Clinical Trial Results:
A randomised, double-blind, placebo-controlled, 3 way, incomplete block cross over study in subjects with allergic rhinitis to assess the effect of once daily single and repeat doses of intranasal Fluticasone furoate/Levocabastine fixed dose combination (FDC) relative to Levocabastine and Fluticasone furoate alone on the onset and magnitude of symptoms of rhinitis in an allergen challenge chamber

Trial information Top of page
Trial identification
Sponsor protocol code	200286
Additional study identifiers
ISRCTN number	-
US NCT number	-
WHO universal trial number (UTN)	-
Sponsors
Sponsor organisation name	GlaxoSmithKline
Sponsor organisation address	980 Great West Road, Brentford, Middlesex, United Kingdom,
Public contact	GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
Scientific contact	GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
Paediatric regulatory details
Is trial part of an agreed paediatric investigation plan (PIP)	No
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?	No
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?	No
Results analysis stage
Analysis stage	Final
Date of interim/final analysis	20 Feb 2014
Is this the analysis of the primary completion data?	No
Global end of trial reached?	Yes
Global end of trial date	20 Feb 2014
Was the trial ended prematurely?	No
General information about the trial
Main objective of the trial	Effect of 8 day treatment with intranasal FF/levocabastine on nasal symptoms elicited by an allergen chamber challenge in subjects with allergic rhinitis when administered once daily compared with FF and levocabastine alone.
Protection of trial subjects	Safety assessments at screen, Day 1, Day 8 and follow up.
Background therapy	-
Evidence for comparator	-
Actual start date of recruitment	14 Nov 2013
Long term follow-up planned	No
Independent data monitoring committee (IDMC) involvement?	No
Population of trial subjects
Number of subjects enrolled per country
Country: Number of subjects enrolled	Austria: 71
Worldwide total number of subjects	71
EEA total number of subjects	71
Number of subjects enrolled per age group
In utero	0
Preterm newborn - gestational age < 37 wk	0
Newborns (0-27 days)	0
Infants and toddlers (28 days-23 months)	0
Children (2-11 years)	0
Adolescents (12-17 years)	0
Adults (18-64 years)	71
From 65 to 84 years	0
85 years and over	0

Trial information Top of page

Subject disposition Top of page
Recruitment
Recruitment details	-
Pre-assignment
Screening details	Participants (par.) who met the eligibility criteria at Screening were randomized to 1 of 18 treatment sequences. The treatment phase was comprised of three 8-day treatment periods, each separated by a 14- to 28-day washout period.
Period 1
Period 1 title	Treatment Period 1 (8 days) (Overall)
Is this the baseline period?	Yes
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator, Monitor, Data analyst
Arms
Are arms mutually exclusive	Yes
Arm title	Sequence 1: Levo 200 µg, FF 100 μg/Levo 200 μg, placebo
Arm description	Participants received levocabastine (Levo) 200 micrograms (µg), fluticasone furoate (FF) 100 μg/Levo 200 μg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg once daily (OD) in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 2: Levo 200 µg, FF 100 μg, FF 100 μg/Levo 200 μg
Arm description	Participants received Levo 200 µg, FF 100 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 3: Levo 200 µg, FF 100 μg/Levo 200 μg, FF 100 μg
Arm description	Participants received Levo 200 µg, FF 100 μg/Levo 200 μg and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 4: Placebo, FF 100 μg, FF 100 μg/Levo 200 μg
Arm description	Participants received placebo, FF 100 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays and FF 100 µg OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 5: Placebo, FF 100 μg/Levo 200 μg, Levo 200 μg
Arm description	Participants received placebo, FF 100 μg/Levo 200 μg and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 6: FF 100 μg/Levo 200 μg, Placebo, Levo 200 μg
Arm description	Participants received FF 100 μg/Levo 200 μg, placebo and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo OD in the morning as 2 nasal sprays and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 7: FF 100 μg, Placebo 200 μg, FF 100 μg/Levo 200 μg
Arm description	Participants received FF 100 µg, placebo and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and placebo OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 8: FF 100 μg/Levo 200 μg, FF 100 μg, Placebo
Arm description	Participants received FF 100 μg/Levo 200 μg, FF 100 µg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 9: Placebo, FF 100 μg/Levo 200 μg, FF 100 μg
Arm description	Participants received placebo, FF 100 μg/Levo 200 μg and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 10: FF 100 μg, FF 100 μg/Levo 200 μg, Levo 200 μg
Arm description	Participants received FF 100 µg, FF 100 μg/Levo 200 μg and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 11: Levo 200 μg, Placebo, FF 100 μg/Levo 200 μg
Arm description	Participants received Levo 200 µg, placebo and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and placebo OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 12: FF 100 μg/Levo 200 μg, Levo 200 μg, FF 100 μg
Arm description	Participants received FF 100 μg/Levo 200 μg, Levo 200 µg and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 13: FF 100 μg/Levo 200 μg, Levo 200 μg, Placebo
Arm description	Participants received FF 100 μg/Levo 200 μg, Levo 200 µg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 14: FF 100 μg, FF 100 μg/Levo 200 μg, Placebo
Arm description	Participants received FF 100 µg, FF 100 μg/Levo 200 μg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 15: FF 100 μg/Levo 200 μg, FF 100 μg, Levo 200 μg
Arm description	Participants received FF 100 μg/Levo 200 μg, FF 100 µg and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 16: FF 100 μg/Levo 200 μg, Placebo, FF 100 μg
Arm description	Participants received FF 100 μg/Levo 200 μg, placebo and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo OD in the morning as 2 nasal sprays and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 17: FF 100 μg, Levo 200 μg, FF 100 μg/Levo 200 μg
Arm description	Participants received FF 100 µg, Levo 200 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 18: Placebo, Levo 200 μg, FF 100 μg/Levo 200 μg
Arm description	Participants received placebo, Levo 200 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Number of subjects in period 1 Sequence 1: Levo 200 µg, FF 100 μg/Levo 200 μg, placebo Sequence 2: Levo 200 µg, FF 100 μg, FF 100 μg/Levo 200 μg Sequence 3: Levo 200 µg, FF 100 μg/Levo 200 μg, FF 100 μg Sequence 4: Placebo, FF 100 μg, FF 100 μg/Levo 200 μg Sequence 5: Placebo, FF 100 μg/Levo 200 μg, Levo 200 μg Sequence 6: FF 100 μg/Levo 200 μg, Placebo, Levo 200 μg Sequence 7: FF 100 μg, Placebo 200 μg, FF 100 μg/Levo 200 μg Sequence 8: FF 100 μg/Levo 200 μg, FF 100 μg, Placebo Sequence 9: Placebo, FF 100 μg/Levo 200 μg, FF 100 μg Sequence 10: FF 100 μg, FF 100 μg/Levo 200 μg, Levo 200 μg Sequence 11: Levo 200 μg, Placebo, FF 100 μg/Levo 200 μg Sequence 12: FF 100 μg/Levo 200 μg, Levo 200 μg, FF 100 μg Sequence 13: FF 100 μg/Levo 200 μg, Levo 200 μg, Placebo Sequence 14: FF 100 μg, FF 100 μg/Levo 200 μg, Placebo Sequence 15: FF 100 μg/Levo 200 μg, FF 100 μg, Levo 200 μg Sequence 16: FF 100 μg/Levo 200 μg, Placebo, FF 100 μg Sequence 17: FF 100 μg, Levo 200 μg, FF 100 μg/Levo 200 μg Sequence 18: Placebo, Levo 200 μg, FF 100 μg/Levo 200 μg Started 3 6 6 3 3 2 3 3 3 6 3 6 3 3 6 3 6 3 Completed 3 6 6 3 3 2 3 3 3 6 3 6 3 3 6 3 6 3
Period 2
Period 2 title	Washout Period 1 (14 to 28 days)
Is this the baseline period?	No
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator, Monitor, Data analyst
Arms
Are arms mutually exclusive	Yes
Arm title	Sequence 1: Levo 200 µg, FF 100 μg/Levo 200 μg, placebo
Arm description	Participants received Levo 200 µg, FF 100 μg/Levo 200 μg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 2: Levo 200 µg, FF 100 μg, FF 100 μg/Levo 200 μg
Arm description	Participants received Levo 200 µg, FF 100 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 3: Levo 200 µg, FF 100 μg/Levo 200 μg, FF 100 μg
Arm description	Participants received Levo 200 µg, FF 100 μg/Levo 200 μg and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 4: Placebo, FF 100 μg, FF 100 μg/Levo 200 μg
Arm description	Participants received placebo, FF 100 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays and FF 100 µg OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 5: Placebo, FF 100 μg/Levo 200 μg, Levo 200 μg
Arm description	Participants received placebo, FF 100 μg/Levo 200 μg and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 6: FF 100 μg/Levo 200 μg, Placebo, Levo 200 μg
Arm description	Participants received FF 100 μg/Levo 200 μg, placebo and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo OD in the morning as 2 nasal sprays and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 7: FF 100 μg, Placebo 200 μg, FF 100 μg/Levo 200 μg
Arm description	Participants received FF 100 µg, placebo and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and placebo OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 8: FF 100 μg/Levo 200 μg, FF 100 μg, Placebo
Arm description	Participants received FF 100 μg/Levo 200 μg, FF 100 µg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 9: Placebo, FF 100 μg/Levo 200 μg, FF 100 μg
Arm description	Participants received placebo, FF 100 μg/Levo 200 μg and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 10: FF 100 μg, FF 100 μg/Levo 200 μg, Levo 200 μg
Arm description	Participants received FF 100 µg, FF 100 μg/Levo 200 μg and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 11: Levo 200 μg, Placebo, FF 100 μg/Levo 200 μg
Arm description	Participants received Levo 200 µg, placebo and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and placebo OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 12: FF 100 μg/Levo 200 μg, Levo 200 μg, FF 100 μg
Arm description	Participants received FF 100 μg/Levo 200 μg, Levo 200 µg and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 13: FF 100 μg/Levo 200 μg, Levo 200 μg, Placebo
Arm description	Participants received FF 100 μg/Levo 200 μg, Levo 200 µg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 14: FF 100 μg, FF 100 μg/Levo 200 μg, Placebo
Arm description	Participants received FF 100 µg, FF 100 μg/Levo 200 μg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 15: FF 100 μg/Levo 200 μg, FF 100 μg, Levo 200 μg
Arm description	Participants received FF 100 μg/Levo 200 μg, FF 100 µg and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 16: FF 100 μg/Levo 200 μg, Placebo, FF 100 μg
Arm description	Participants received FF 100 μg/Levo 200 μg, placebo and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo OD in the morning as 2 nasal sprays and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 17: FF 100 μg, Levo 200 μg, FF 100 μg/Levo 200 μg
Arm description	Participants received FF 100 µg, Levo 200 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 18: Placebo, Levo 200 μg, FF 100 μg/Levo 200 μg
Arm description	Participants received placebo, Levo 200 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Number of subjects in period 2 Sequence 1: Levo 200 µg, FF 100 μg/Levo 200 μg, placebo Sequence 2: Levo 200 µg, FF 100 μg, FF 100 μg/Levo 200 μg Sequence 3: Levo 200 µg, FF 100 μg/Levo 200 μg, FF 100 μg Sequence 4: Placebo, FF 100 μg, FF 100 μg/Levo 200 μg Sequence 5: Placebo, FF 100 μg/Levo 200 μg, Levo 200 μg Sequence 6: FF 100 μg/Levo 200 μg, Placebo, Levo 200 μg Sequence 7: FF 100 μg, Placebo 200 μg, FF 100 μg/Levo 200 μg Sequence 8: FF 100 μg/Levo 200 μg, FF 100 μg, Placebo Sequence 9: Placebo, FF 100 μg/Levo 200 μg, FF 100 μg Sequence 10: FF 100 μg, FF 100 μg/Levo 200 μg, Levo 200 μg Sequence 11: Levo 200 μg, Placebo, FF 100 μg/Levo 200 μg Sequence 12: FF 100 μg/Levo 200 μg, Levo 200 μg, FF 100 μg Sequence 13: FF 100 μg/Levo 200 μg, Levo 200 μg, Placebo Sequence 14: FF 100 μg, FF 100 μg/Levo 200 μg, Placebo Sequence 15: FF 100 μg/Levo 200 μg, FF 100 μg, Levo 200 μg Sequence 16: FF 100 μg/Levo 200 μg, Placebo, FF 100 μg Sequence 17: FF 100 μg, Levo 200 μg, FF 100 μg/Levo 200 μg Sequence 18: Placebo, Levo 200 μg, FF 100 μg/Levo 200 μg Started 3 6 6 3 3 2 3 3 3 6 3 6 3 3 6 3 6 3 Completed 3 6 6 3 3 2 3 3 3 6 3 6 3 3 6 3 6 3
Period 3
Period 3 title	Treatment Period 2 (8 days)
Is this the baseline period?	No
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator, Monitor, Data analyst
Arms
Are arms mutually exclusive	Yes
Arm title	Sequence 1: Levo 200 µg, FF 100 μg/Levo 200 μg, placebo
Arm description	Participants received Levo 200 µg, FF 100 μg/Levo 200 μg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 2: Levo 200 µg, FF 100 μg, FF 100 μg/Levo 200 μg
Arm description	Participants received Levo 200 µg, FF 100 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 3: Levo 200 µg, FF 100 μg/Levo 200 μg, FF 100 μg
Arm description	Participants received Levo 200 µg, FF 100 μg/Levo 200 μg and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 4: Placebo, FF 100 μg, FF 100 μg/Levo 200 μg
Arm description	Participants received placebo, FF 100 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays and FF 100 µg OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 5: Placebo, FF 100 μg/Levo 200 μg, Levo 200 μg
Arm description	Participants received placebo, FF 100 μg/Levo 200 μg and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 6: FF 100 μg/Levo 200 μg, Placebo, Levo 200 μg
Arm description	Participants received FF 100 μg/Levo 200 μg, placebo and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo OD in the morning as 2 nasal sprays and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 7: FF 100 μg, Placebo 200 μg, FF 100 μg/Levo 200 μg
Arm description	Participants received FF 100 µg, placebo and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and placebo OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 8: FF 100 μg/Levo 200 μg, FF 100 μg, Placebo
Arm description	Participants received FF 100 μg/Levo 200 μg, FF 100 µg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 9: Placebo, FF 100 μg/Levo 200 μg, FF 100 μg
Arm description	Participants received placebo, FF 100 μg/Levo 200 μg and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 10: FF 100 μg, FF 100 μg/Levo 200 μg, Levo 200 μg
Arm description	Participants received FF 100 µg, FF 100 μg/Levo 200 μg and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 11: Levo 200 μg, Placebo, FF 100 μg/Levo 200 μg
Arm description	Participants received Levo 200 µg, placebo and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and placebo OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 12: FF 100 μg/Levo 200 μg, Levo 200 μg, FF 100 μg
Arm description	Participants received FF 100 μg/Levo 200 μg, Levo 200 µg and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 13: FF 100 μg/Levo 200 μg, Levo 200 μg, Placebo
Arm description	Participants received FF 100 μg/Levo 200 μg, Levo 200 µg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 14: FF 100 μg, FF 100 μg/Levo 200 μg, Placebo
Arm description	Participants received FF 100 µg, FF 100 μg/Levo 200 μg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 15: FF 100 μg/Levo 200 μg, FF 100 μg, Levo 200 μg
Arm description	Participants received FF 100 μg/Levo 200 μg, FF 100 µg and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 16: FF 100 μg/Levo 200 μg, Placebo, FF 100 μg
Arm description	Participants received FF 100 μg/Levo 200 μg, placebo and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo OD in the morning as 2 nasal sprays and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 17: FF 100 μg, Levo 200 μg, FF 100 μg/Levo 200 μg
Arm description	Participants received FF 100 µg, Levo 200 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 18: Placebo, Levo 200 μg, FF 100 μg/Levo 200 μg
Arm description	Participants received placebo, Levo 200 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Number of subjects in period 3 Sequence 1: Levo 200 µg, FF 100 μg/Levo 200 μg, placebo Sequence 2: Levo 200 µg, FF 100 μg, FF 100 μg/Levo 200 μg Sequence 3: Levo 200 µg, FF 100 μg/Levo 200 μg, FF 100 μg Sequence 4: Placebo, FF 100 μg, FF 100 μg/Levo 200 μg Sequence 5: Placebo, FF 100 μg/Levo 200 μg, Levo 200 μg Sequence 6: FF 100 μg/Levo 200 μg, Placebo, Levo 200 μg Sequence 7: FF 100 μg, Placebo 200 μg, FF 100 μg/Levo 200 μg Sequence 8: FF 100 μg/Levo 200 μg, FF 100 μg, Placebo Sequence 9: Placebo, FF 100 μg/Levo 200 μg, FF 100 μg Sequence 10: FF 100 μg, FF 100 μg/Levo 200 μg, Levo 200 μg Sequence 11: Levo 200 μg, Placebo, FF 100 μg/Levo 200 μg Sequence 12: FF 100 μg/Levo 200 μg, Levo 200 μg, FF 100 μg Sequence 13: FF 100 μg/Levo 200 μg, Levo 200 μg, Placebo Sequence 14: FF 100 μg, FF 100 μg/Levo 200 μg, Placebo Sequence 15: FF 100 μg/Levo 200 μg, FF 100 μg, Levo 200 μg Sequence 16: FF 100 μg/Levo 200 μg, Placebo, FF 100 μg Sequence 17: FF 100 μg, Levo 200 μg, FF 100 μg/Levo 200 μg Sequence 18: Placebo, Levo 200 μg, FF 100 μg/Levo 200 μg Started 3 6 6 3 3 2 3 3 3 6 3 6 3 3 6 3 6 3 Completed 3 5 6 3 3 2 3 3 3 6 3 6 3 3 6 3 5 3 Not completed 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0      Consent withdrawn by subject - 1 - - - - - - - - - - - - - - 1 -
Period 4
Period 4 title	Washout Period 2 (14 to 28 days)
Is this the baseline period?	No
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator, Monitor, Data analyst
Arms
Are arms mutually exclusive	Yes
Arm title	Sequence 1: Levo 200 µg, FF 100 μg/Levo 200 μg, placebo
Arm description	Participants received Levo 200 µg, FF 100 μg/Levo 200 μg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 2: Levo 200 µg, FF 100 μg, FF 100 μg/Levo 200 μg
Arm description	Participants received Levo 200 µg, FF 100 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 3: Levo 200 µg, FF 100 μg/Levo 200 μg, FF 100 μg
Arm description	Participants received Levo 200 µg, FF 100 μg/Levo 200 μg and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 4: Placebo, FF 100 μg, FF 100 μg/Levo 200 μg
Arm description	Participants received placebo, FF 100 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays and FF 100 µg OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 5: Placebo, FF 100 μg/Levo 200 μg, Levo 200 μg
Arm description	Participants received placebo, FF 100 μg/Levo 200 μg and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 6: FF 100 μg/Levo 200 μg, Placebo, Levo 200 μg
Arm description	Participants received FF 100 μg/Levo 200 μg, placebo and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo OD in the morning as 2 nasal sprays and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 7: FF 100 μg, Placebo 200 μg, FF 100 μg/Levo 200 μg
Arm description	Participants received FF 100 µg, placebo and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and placebo OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 8: FF 100 μg/Levo 200 μg, FF 100 μg, Placebo
Arm description	Participants received FF 100 μg/Levo 200 μg, FF 100 µg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 9: Placebo, FF 100 μg/Levo 200 μg, FF 100 μg
Arm description	Participants received placebo, FF 100 μg/Levo 200 μg and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 10: FF 100 μg, FF 100 μg/Levo 200 μg, Levo 200 μg
Arm description	Participants received FF 100 µg, FF 100 μg/Levo 200 μg and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 11: Levo 200 μg, Placebo, FF 100 μg/Levo 200 μg
Arm description	Participants received Levo 200 µg, placebo and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and placebo OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 12: FF 100 μg/Levo 200 μg, Levo 200 μg, FF 100 μg
Arm description	Participants received FF 100 μg/Levo 200 μg, Levo 200 µg and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 13: FF 100 μg/Levo 200 μg, Levo 200 μg, Placebo
Arm description	Participants received FF 100 μg/Levo 200 μg, Levo 200 µg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 14: FF 100 μg, FF 100 μg/Levo 200 μg, Placebo
Arm description	Participants received FF 100 µg, FF 100 μg/Levo 200 μg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 15: FF 100 μg/Levo 200 μg, FF 100 μg, Levo 200 μg
Arm description	Participants received FF 100 μg/Levo 200 μg, FF 100 µg and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 16: FF 100 μg/Levo 200 μg, Placebo, FF 100 μg
Arm description	Participants received FF 100 μg/Levo 200 μg, placebo and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo OD in the morning as 2 nasal sprays and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 17: FF 100 μg, Levo 200 μg, FF 100 μg/Levo 200 μg
Arm description	Participants received FF 100 µg, Levo 200 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 18: Placebo, Levo 200 μg, FF 100 μg/Levo 200 μg
Arm description	Participants received placebo, Levo 200 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Number of subjects in period 4 Sequence 1: Levo 200 µg, FF 100 μg/Levo 200 μg, placebo Sequence 2: Levo 200 µg, FF 100 μg, FF 100 μg/Levo 200 μg Sequence 3: Levo 200 µg, FF 100 μg/Levo 200 μg, FF 100 μg Sequence 4: Placebo, FF 100 μg, FF 100 μg/Levo 200 μg Sequence 5: Placebo, FF 100 μg/Levo 200 μg, Levo 200 μg Sequence 6: FF 100 μg/Levo 200 μg, Placebo, Levo 200 μg Sequence 7: FF 100 μg, Placebo 200 μg, FF 100 μg/Levo 200 μg Sequence 8: FF 100 μg/Levo 200 μg, FF 100 μg, Placebo Sequence 9: Placebo, FF 100 μg/Levo 200 μg, FF 100 μg Sequence 10: FF 100 μg, FF 100 μg/Levo 200 μg, Levo 200 μg Sequence 11: Levo 200 μg, Placebo, FF 100 μg/Levo 200 μg Sequence 12: FF 100 μg/Levo 200 μg, Levo 200 μg, FF 100 μg Sequence 13: FF 100 μg/Levo 200 μg, Levo 200 μg, Placebo Sequence 14: FF 100 μg, FF 100 μg/Levo 200 μg, Placebo Sequence 15: FF 100 μg/Levo 200 μg, FF 100 μg, Levo 200 μg Sequence 16: FF 100 μg/Levo 200 μg, Placebo, FF 100 μg Sequence 17: FF 100 μg, Levo 200 μg, FF 100 μg/Levo 200 μg Sequence 18: Placebo, Levo 200 μg, FF 100 μg/Levo 200 μg Started 3 5 6 3 3 2 3 3 3 6 3 6 3 3 6 3 5 3 Completed 3 5 6 3 3 2 3 3 3 6 3 6 3 3 6 3 5 3
Period 5
Period 5 title	Treatment Period 3 (8 days)
Is this the baseline period?	No
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator, Monitor, Data analyst
Arms
Are arms mutually exclusive	Yes
Arm title	Sequence 1: Levo 200 µg, FF 100 μg/Levo 200 μg, placebo
Arm description	Participants received Levo 200 µg, fluticasone furoate (FF) 100 μg/Levo 200 μg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 2: Levo 200 µg, FF 100 μg, FF 100 μg/Levo 200 μg
Arm description	Participants received Levo 200 µg, FF 100 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 3: Levo 200 µg, FF 100 μg/Levo 200 μg, FF 100 μg
Arm description	Participants received Levo 200 µg, FF 100 μg/Levo 200 μg and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 4: Placebo, FF 100 μg, FF 100 μg/Levo 200 μg
Arm description	Participants received placebo, FF 100 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays and FF 100 µg OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 5: Placebo, FF 100 μg/Levo 200 μg, Levo 200 μg
Arm description	Participants received placebo, FF 100 μg/Levo 200 μg and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 6: FF 100 μg/Levo 200 μg, Placebo, Levo 200 μg
Arm description	Participants received FF 100 μg/Levo 200 μg, placebo and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo OD in the morning as 2 nasal sprays and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 7: FF 100 μg, Placebo 200 μg, FF 100 μg/Levo 200 μg
Arm description	Participants received FF 100 µg, placebo and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and placebo OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 8: FF 100 μg/Levo 200 μg, FF 100 μg, Placebo
Arm description	Participants received FF 100 μg/Levo 200 μg, FF 100 µg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 9: Placebo, FF 100 μg/Levo 200 μg, FF 100 μg
Arm description	Participants received placebo, FF 100 μg/Levo 200 μg and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 10: FF 100 μg, FF 100 μg/Levo 200 μg, Levo 200 μg
Arm description	Participants received FF 100 µg, FF 100 μg/Levo 200 μg and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 11: Levo 200 μg, Placebo, FF 100 μg/Levo 200 μg
Arm description	Participants received Levo 200 µg, placebo and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and placebo OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 12: FF 100 μg/Levo 200 μg, Levo 200 μg, FF 100 μg
Arm description	Participants received FF 100 μg/Levo 200 μg, Levo 200 µg and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 13: FF 100 μg/Levo 200 μg, Levo 200 μg, Placebo
Arm description	Participants received FF 100 μg/Levo 200 μg, Levo 200 µg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 14: FF 100 μg, FF 100 μg/Levo 200 μg, Placebo
Arm description	Participants received FF 100 µg, FF 100 μg/Levo 200 μg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 15: FF 100 μg/Levo 200 μg, FF 100 μg, Levo 200 μg
Arm description	Participants received FF 100 μg/Levo 200 μg, FF 100 µg and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 16: FF 100 μg/Levo 200 μg, Placebo, FF 100 μg
Arm description	Participants received FF 100 μg/Levo 200 μg, placebo and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo OD in the morning as 2 nasal sprays and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 17: FF 100 μg, Levo 200 μg, FF 100 μg/Levo 200 μg
Arm description	Participants received FF 100 µg, Levo 200 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Arm title	Sequence 18: Placebo, Levo 200 μg, FF 100 μg/Levo 200 μg
Arm description	Participants received placebo, Levo 200 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
Arm type	Active comparator:Experimental:Placebo
Investigational medicinal product name	Fluticasone furoate
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	levocabastine
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25 µg once daily
Investigational medicinal product name	Fluticasone furoate +levocabastine as fixed dose combination
Investigational medicinal product code
Other name
Pharmaceutical forms	Nasal spray, solution
Routes of administration	Intranasal use
Dosage and administration details	25µg/50 µg once daily
Number of subjects in period 5 Sequence 1: Levo 200 µg, FF 100 μg/Levo 200 μg, placebo Sequence 2: Levo 200 µg, FF 100 μg, FF 100 μg/Levo 200 μg Sequence 3: Levo 200 µg, FF 100 μg/Levo 200 μg, FF 100 μg Sequence 4: Placebo, FF 100 μg, FF 100 μg/Levo 200 μg Sequence 5: Placebo, FF 100 μg/Levo 200 μg, Levo 200 μg Sequence 6: FF 100 μg/Levo 200 μg, Placebo, Levo 200 μg Sequence 7: FF 100 μg, Placebo 200 μg, FF 100 μg/Levo 200 μg Sequence 8: FF 100 μg/Levo 200 μg, FF 100 μg, Placebo Sequence 9: Placebo, FF 100 μg/Levo 200 μg, FF 100 μg Sequence 10: FF 100 μg, FF 100 μg/Levo 200 μg, Levo 200 μg Sequence 11: Levo 200 μg, Placebo, FF 100 μg/Levo 200 μg Sequence 12: FF 100 μg/Levo 200 μg, Levo 200 μg, FF 100 μg Sequence 13: FF 100 μg/Levo 200 μg, Levo 200 μg, Placebo Sequence 14: FF 100 μg, FF 100 μg/Levo 200 μg, Placebo Sequence 15: FF 100 μg/Levo 200 μg, FF 100 μg, Levo 200 μg Sequence 16: FF 100 μg/Levo 200 μg, Placebo, FF 100 μg Sequence 17: FF 100 μg, Levo 200 μg, FF 100 μg/Levo 200 μg Sequence 18: Placebo, Levo 200 μg, FF 100 μg/Levo 200 μg Started 3 5 6 3 3 2 3 3 3 6 3 6 3 3 6 3 5 3 Completed 3 5 6 3 3 2 3 3 3 6 3 6 3 3 6 3 4 3 Not completed 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0      Adverse event, non-fatal - - - - - - - - - - - - - - - - 1 -