Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre Study to Evaluate the Efficacy and Safety of Once-Daily Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 6 Weeks in Adult and Adolescent Subjects 12 years of Age and Older with Perennial Allergic Rhinitis (PAR)

    Summary
    EudraCT number
    		 2005-004493-25
    Trial protocol
    		 LT   EE   LV   DE  
    Global end of trial date
    04 Jul 2006

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Apr 2016
    First version publication date
    20 Jun 2015
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    FFR106080
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00289198
    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 8664357343,
    Scientific contact
    GSK Response Center, GlaxoSmithKline, +1 8664357343,
    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
    11 Aug 2006
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Jul 2006
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg QD aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with PAR.
    Protection of trial subjects
    Participants were allowed to use short-acting inhaled beta2 agonists only on an as needed basis. Any clinically significant AE, laboratory test, nasal examination, ECG finding, or clinically significant unfavorable change observed during the Early Withdrawal Visit necessitated that the subject be followed or treated until satisfactory resolution occurred.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Feb 2006
    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
    Estonia: 34
    Country: Number of subjects enrolled
    Germany: 14
    Country: Number of subjects enrolled
    Latvia: 33
    Country: Number of subjects enrolled
    Lithuania: 36
    Country: Number of subjects enrolled
    Australia: 37
    Country: Number of subjects enrolled
    Canada: 66
    Country: Number of subjects enrolled
    New Zealand: 24
    Country: Number of subjects enrolled
    Russian Federation: 28
    Country: Number of subjects enrolled
    United States: 30
    Worldwide total number of subjects
    302
    EEA total number of subjects
    117
    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)
    39
    Adults (18-64 years)
    238
    From 65 to 84 years
    25
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Following a 7 to 14-day screening period, participants who met randomisation criteria were randomised to 6 weeks of treatment with fluticasone furoate (FF) or placebo nasal spray once daily (QD). A total of 302 participants were randomised, 151 in each of the treatment groups.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants received a blinded matching placebo aqueous nasal spray once daily (QD) every morning for 6 weeks. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days.
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    Self administer by alternately spraying one spray to each nostril followed by a second spray to each nostril (two sprays per nostril) once daily for 42 days

    Arm title
    		 FF 110 µg QD
    Arm description
    		 Participants received a blinded fluticasone furoate (FF) aqueous nasal spray 110 microgram (µg) QD every morning for 6 weeks. Dose was administered by alternately spraying one spray (27.5 µg per spray) into each nostril followed by a second spray into each nostril for 42 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fluticasone furoate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    Self administer by alternately spraying one spray to each nostril followed by a second spray to each nostril (two sprays per nostril) once daily for 42 days. Each spray of the suspension will contain approximately 27.5 µg of GW685698X.

    Number of subjects in period 1
    		Placebo FF 110 µg QD
    Started
    151
    151
    Completed
    120
    121
    Not completed
    31
    30
         Consent withdrawn by subject
    4
    1
         Physician decision
    -
    1
         Low compliance
    -
    1
         Adverse event, non-fatal
    -
    2
         Impossible to come on schedule visit
    -
    1
         Unable to attend on schedule
    2
    1
         Miscalculation of visit date
    21
    22
         Lack of efficacy
    2
    -
         Protocol deviation
    2
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a blinded matching placebo aqueous nasal spray once daily (QD) every morning for 6 weeks. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days.

    Reporting group title
    FF 110 µg QD
    Reporting group description
    		 Participants received a blinded fluticasone furoate (FF) aqueous nasal spray 110 microgram (µg) QD every morning for 6 weeks. Dose was administered by alternately spraying one spray (27.5 µg per spray) into each nostril followed by a second spray into each nostril for 42 days.

    Reporting group values
    		 Placebo FF 110 µg QD Total
    Number of subjects
    		 151 151 302
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 37.2 ( 16.2 ) 37.1 ( 16.57 ) -
    Gender categorical
    Units: Subjects
        Female
    		 86 85 171
        Male
    		 65 66 131
    Race, Customized
    Units: Subjects
        African American/African Heritage
    		 3 4 7
        American Indian or Alaska Native
    		 1 0 1
        Asian - Central/South Asian Heritage
    		 1 2 3
        Asian - East Asian Heritage
    		 1 1 2
        Asian - South East Asian Heritage
    		 4 6 10
        Native Hawaiian or other Pacific Islander
    		 0 3 3
        White - Arabic/North African Heritage
    		 1 0 1
        White - White/Caucasian/European Heritage
    		 139 135 274
        Mixed Race
    		 1 0 1

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a blinded matching placebo aqueous nasal spray once daily (QD) every morning for 6 weeks. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days.

    Reporting group title
    FF 110 µg QD
    Reporting group description
    		 Participants received a blinded fluticasone furoate (FF) aqueous nasal spray 110 microgram (µg) QD every morning for 6 weeks. Dose was administered by alternately spraying one spray (27.5 µg per spray) into each nostril followed by a second spray into each nostril for 42 days.

    Primary: Mean change from Baseline (BL) in daily reflective total nasal symptom score (rTNSS) over the entire treatment period

    		 Close Top of page
    End point title
    		 Mean change from Baseline (BL) in daily reflective total nasal symptom score (rTNSS) over the entire treatment period
    End point description
    TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in morning (AM) and evening (PM). Daily rTNSS is defined as average of the PM rTNSS and the AM rTNSS of the next day prior to AM dosing. The BL daily rTNSS is defined as the average of the daily rTNSS over 4 consecutive 24-hour periods prior to randomization plus randomization day AM assessment. Change from BL was calculated as average of the non-missing daily rTNSS minus BL daily rTNSS. Analysis was performed using analysis of covariance (ANCOVA), adjusting for BL daily rTNSS, country, age, and gender. The Intent To Treat (ITT) Population comprised of all randomized participants who received >=1 dose of study drug. Only those participants available at the specified time points were analyzed.
    End point type
    Primary
    End point timeframe
    From Baseline up to Week 6
    End point values
    		 Placebo FF 110 µg QD
    Number of subjects analysed
    150 [1]
    151 [2]
    Units: Scores on a scale
        least squares mean (standard error)
    -2.69 ( 0.18 )
    -3.95 ( 0.18 )
    Notes
    [1] - ITT Population
    [2] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v FF 110 µg QD
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.256
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.73
         upper limit
    		 -0.78

    Secondary: Mean change from Baseline in AM pre-dose instantaneous TNSS (iTNSS) over the entire treatment period

    		 Close Top of page
    End point title
    		 Mean change from Baseline in AM pre-dose instantaneous TNSS (iTNSS) over the entire treatment period
    End point description
    The AM pre-dose iTNSS is the sum of the 4 individual nasal symptom score assessments for rhinorrhea, nasal congestion, nasal itching, and sneezing performed at the moment immediately prior to taking the daily dose; each symptom is scored on a scale of 0 (none) to 3 (severe). Baseline iTNSS is defined as the average of the non-missing values for iTNSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 6
    End point values
    		 Placebo FF 110 µg QD
    Number of subjects analysed
    149 [3]
    150 [4]
    Units: Scores on a scale
        least squares mean (standard error)
    -2.36 ( 0.18 )
    -3.82 ( 0.18 )
    Notes
    [3] - ITT Population
    [4] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v FF 110 µg QD
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.459
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.93
         upper limit
    		 -0.99

    Secondary: Number of participants with response to therapy at Week 6

    		 Close Top of page
    End point title
    		 Number of participants with response to therapy at Week 6
    End point description
    Response to therapy is defined as the effectiveness of FF for relieving allergic rhinitis symptoms over the entire treatment period. Response was, evaluated at the end of the study (Week 6) using a 7-point categorical scale, categorized as: 1=significantly improved, 2=moderately improved, 3=mildly improved, 4=no change, 5=mildly worse, 6=moderately worse, 7=significantly worse. Analysis was performed using logistic regression to evaluate treatment effect, adjusting for age, gender, and country.
    End point type
    Secondary
    End point timeframe
    Week 6
    End point values
    		 Placebo FF 110 µg QD
    Number of subjects analysed
    151 [5]
    151 [6]
    Units: Participants
    number (not applicable)
        Significantly improved
    21
    56
        Moderately Improved
    38
    37
        Mildly Improved
    37
    31
        No Change
    45
    20
        Mildly Worse
    5
    2
        Moderately Worse
    3
    3
        Significantly Worse
    2
    2
    Notes
    [5] - ITT Population
    [6] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v FF 110 µg QD
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Confidence interval

    Secondary: Mean change from Baseline in AM rTNSS over the entire treatment period

    		 Close Top of page
    End point title
    		 Mean change from Baseline in AM rTNSS over the entire treatment period
    End point description
    TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The AM rTNSS is a rating of the severity of symptoms performed in the morning prior to administering the dose of study drug and assesses how the participant felt during the night (preceding 12 hours). Baseline rTNSS is defined as the average of the non-missing values for rTNSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those par. available at the specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 6
    End point values
    		 Placebo FF 110 µg QD
    Number of subjects analysed
    149 [7]
    150 [8]
    Units: Scores on a scale
        least squares mean (standard error)
    -2.66 ( 0.17 )
    -3.93 ( 0.17 )
    Notes
    [7] - ITT Population
    [8] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v FF 110 µg QD
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.274
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.74
         upper limit
    		 -0.81

    Secondary: Mean change from Baseline in PM rTNSS over the entire treatment period

    		 Close Top of page
    End point title
    		 Mean change from Baseline in PM rTNSS over the entire treatment period
    End point description
    TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The PM rTNSS is a rating of the severity of symptoms performed approximately 12 hours after dosing and before bedtime and assesses how the participant felt during the day. Baseline rTNSS is defined as the average of the non-missing values for rTNSS during the Baseline period where the baseline period includes the 4 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those par. available at the specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 6
    End point values
    		 Placebo FF 110 µg QD
    Number of subjects analysed
    150 [9]
    150 [10]
    Units: Scores on a scale
        least squares mean (standard error)
    -2.73 ( 0.18 )
    -4.02 ( 0.18 )
    Notes
    [9] - ITT Population
    [10] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v FF 110 µg QD
    Number of subjects included in analysis
    300
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.291
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.77
         upper limit
    		 -0.81

    Secondary: Mean percent change from Baseline in Daily rTNSS over the entire treatment period

    		 Close Top of page
    End point title
    		 Mean percent change from Baseline in Daily rTNSS over the entire treatment period
    End point description
    TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in morning (AM) and evening (PM). Daily rTNSS is defined as average of the PM rTNSS and the AM rTNSS of the next day prior to AM dosing. The BL daily rTNSS is defined as the average of the daily rTNSS over 4 consecutive 24-hour periods prior to randomization plus randomization day AM assessment. Change from BL was calculated as average of the non-missing daily rTNSS minus BL daily rTNSS. Percentage change from BL was calculated as: (change from BL/BL)*100. Analysis was performed using ANCOVA, adjusting for BL daily rTNSS, country, age, and gender. Only those par. available at the specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 6
    End point values
    		 Placebo FF 110 µg QD
    Number of subjects analysed
    150 [11]
    151 [12]
    Units: Percentage of daily rTNSS
        least squares mean (standard error)
    -30.23 ( 2.22 )
    -44.35 ( 2.21 )
    Notes
    [11] - ITT Population
    [12] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v FF 110 µg QD
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -14.118
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.03
         upper limit
    		 -8.21

    Secondary: Mean percent change from Baseline in AM Pre-Dose iTNSS over the entire treatment period

    		 Close Top of page
    End point title
    		 Mean percent change from Baseline in AM Pre-Dose iTNSS over the entire treatment period
    End point description
    TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The AM pre-dose iTNSS is a rating of the severity of symptoms performed at the moment immediately prior to dosing. Baseline iTNSS is defined as the average of the non-missing values for iTNSS during the Baseline period where the Baseline period includes the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Percentage change from Baseline was calculated as: (change from Baseline/Baseline)*100. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those par. available at the specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 6
    End point values
    		 Placebo FF 110 µg QD
    Number of subjects analysed
    149 [13]
    150 [14]
    Units: Percentage of AM pre dose iTNSS
        least squares mean (standard error)
    -24.67 ( 2.66 )
    -44.7 ( 2.66 )
    Notes
    [13] - ITT Population
    [14] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v FF 110 µg QD
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -20.033
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -27.13
         upper limit
    		 -12.94

    Secondary: Mean change from Baseline in daily reflective individual nasal symptom scores (INSS) over the entire treatment period

    		 Close Top of page
    End point title
    		 Mean change from Baseline in daily reflective individual nasal symptom scores (INSS) over the entire treatment period
    End point description
    The individual nasal symptom scores (INSS) for rhinorrhea, nasal congestion, nasal itching and sneezing were assessed on a 4 point (0 [none] to 3 [severe]) categorical scale and larger score indicates severe symptoms. The INSS is a rating of the severity of symptoms over the previous 12 hours and is performed in AM and PM. Daily INSS is defined as average of the PM INSS and the AM INSS of the next day prior to AM dosing. The BL daily INSS is defined as the average of the daily INSS over 4 consecutive 24-hour periods prior to randomization plus randomization day AM assessment. Change from BL was calculated as average of the non-missing daily INSS minus BL daily INSS. Analysis was performed using ANCOVA, adjusting for BL value, country, age, and gender. Only those par. available at the specified time points were analyzed (n=X,X).
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 6
    End point values
    		 Placebo FF 110 µg QD
    Number of subjects analysed
    151 [15]
    151 [16]
    Units: Scores on a scale
    least squares mean (standard error)
        Nasal congestion, n=150,151
    -0.69 ( 0.05 )
    -0.97 ( 0.05 )
        Nasal itching, n=150,151
    -0.65 ( 0.05 )
    -0.98 ( 0.05 )
        Sneezing, n=150,151
    -0.68 ( 0.05 )
    -1.07 ( 0.05 )
        Rhinorrhea, n=149, 150
    -0.67 ( 0.05 )
    -0.94 ( 0.05 )
    Notes
    [15] - ITT Population
    [16] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Daily rINSS for nasal congestion
    Comparison groups
    Placebo v FF 110 µg QD
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.277
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.42
         upper limit
    		 -0.14
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Daily rINSS for nasal itching
    Comparison groups
    Placebo v FF 110 µg QD
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.331
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.47
         upper limit
    		 -0.2
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Daily rINSS for sneezing
    Comparison groups
    Placebo v FF 110 µg QD
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.52
         upper limit
    		 -0.27
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    Daily rINSS for rhinorrhea
    Comparison groups
    Placebo v FF 110 µg QD
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.277
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.41
         upper limit
    		 -0.14

    Secondary: Mean change from Baseline in AM pre-dose instantaneous individual nasal symptom score (iINSS) over the entire treatment period

    		 Close Top of page
    End point title
    		 Mean change from Baseline in AM pre-dose instantaneous individual nasal symptom score (iINSS) over the entire treatment period
    End point description
    iINSS for rhinorrhea, nasal congestion, nasal itching and sneezing were assessed on a 4 point (0 [none] to 3 [severe]) categorical scale and larger score indicates severe symptoms. The AM pre-dose iINSS is a rating of the severity of symptoms performed at the moment immediately prior to dosing. Baseline iINSS is defined as the average of the non-missing values for iINSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those par. available at the specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 6
    End point values
    		 Placebo FF 110 µg QD
    Number of subjects analysed
    149 [17]
    150 [18]
    Units: Scores on a scale
    least squares mean (standard error)
        Rhinorrhea
    -0.57 ( 0.05 )
    -0.93 ( 0.05 )
        Nasal Congestion
    -0.55 ( 0.05 )
    -0.92 ( 0.05 )
        Nasal Itching
    -0.61 ( 0.05 )
    -0.98 ( 0.05 )
        Sneezing
    -0.63 ( 0.05 )
    -1 ( 0.05 )
    Notes
    [17] - ITT Population
    [18] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    AM pre-dose iINSS for rhinorrhea
    Comparison groups
    Placebo v FF 110 µg QD
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.357
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 -0.22
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    AM pre-dose iINSS for nasal congestion
    Comparison groups
    Placebo v FF 110 µg QD
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.51
         upper limit
    		 -0.23
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    AM pre-dose iINSS for nasal itching
    Comparison groups
    Placebo v FF 110 µg QD
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.372
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 -0.24
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    AM pre-dose iINSS for sneezing
    Comparison groups
    Placebo v FF 110 µg QD
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.372
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 -0.24

    Secondary: Mean change from Baseline in AM rINSS over the entire treatment period

    		 Close Top of page
    End point title
    		 Mean change from Baseline in AM rINSS over the entire treatment period
    End point description
    INSS for rhinorrhea, nasal congestion, nasal itching and sneezing were assessed on a 4 point (0 [none] to 3 [severe]) categorical scale and larger score indicates severe symptoms. The AM rINSS is a rating of the severity of symptoms performed in the morning prior to administering the dose of study drug and assesses how the participant felt during the night (preceding 12 hours). Baseline rINSS is defined as the average of the non-missing values for rINSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those par. available at the specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 6
    End point values
    		 Placebo FF 110 µg QD
    Number of subjects analysed
    149 [19]
    150 [20]
    Units: Scores on a scale
    least squares mean (standard error)
        Rhinorrhea
    -0.67 ( 0.05 )
    -0.95 ( 0.05 )
        Nasal Congestion
    -0.66 ( 0.05 )
    -0.98 ( 0.05 )
        Nasal Itching
    -0.64 ( 0.05 )
    -0.96 ( 0.05 )
        Sneezing
    -0.69 ( 0.05 )
    -1.06 ( 0.05 )
    Notes
    [19] - ITT Population
    [20] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    AM rINSS for rhinorrhea
    Comparison groups
    Placebo v FF 110 µg QD
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.281
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.42
         upper limit
    		 -0.14
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    AM rINSS for nasal congestion
    Comparison groups
    Placebo v FF 110 µg QD
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.314
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.45
         upper limit
    		 -0.17
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    AM rINSS for nasal itching
    Comparison groups
    Placebo v FF 110 µg QD
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.324
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.45
         upper limit
    		 -0.19
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    AM rINSS for sneezing
    Comparison groups
    Placebo v FF 110 µg QD
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.374
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 -0.25

    Secondary: Mean change from Baseline in PM rINSS over the entire treatment period

    		 Close Top of page
    End point title
    		 Mean change from Baseline in PM rINSS over the entire treatment period
    End point description
    rINSS for rhinorrhea, nasal congestion, nasal itching and sneezing were assessed on a 4 point (0 [none] to 3 [severe]) categorical scale and larger score indicates severe symptoms. The PM rINSS is a rating of the severity of symptoms performed approximately 12 hours after dosing and before bedtime and assesses how the participant felt during the day. Baseline rINSS is defined as the average of the non-missing values for rINSS during the Baseline period where the Baseline period included the 4 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those par. available at the specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 6
    End point values
    		 Placebo FF 110 µg QD
    Number of subjects analysed
    150 [21]
    150 [22]
    Units: Scores on a scale
    least squares mean (standard error)
        Rhinorrhea
    -0.66 ( 0.05 )
    -0.96 ( 0.05 )
        Nasal congestion
    -0.7 ( 0.05 )
    -0.97 ( 0.05 )
        Nasal itching
    -0.68 ( 0.05 )
    -1.01 ( 0.05 )
        Sneezing
    -0.68 ( 0.05 )
    -1.09 ( 0.05 )
    Notes
    [21] - ITT Population
    [22] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    PM rINSS for rhinorrhea
    Comparison groups
    Placebo v FF 110 µg QD
    Number of subjects included in analysis
    300
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.292
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.43
         upper limit
    		 -0.15
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    PM rINSS for nasal congestion
    Comparison groups
    Placebo v FF 110 µg QD
    Number of subjects included in analysis
    300
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.264
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 -0.12
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    PM rINSS for nasal itching
    Comparison groups
    Placebo v FF 110 µg QD
    Number of subjects included in analysis
    300
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.336
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.48
         upper limit
    		 -0.2
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    PM rINSS for sneezing
    Comparison groups
    Placebo v FF 110 µg QD
    Number of subjects included in analysis
    300
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.412
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.54
         upper limit
    		 -0.28

    Secondary: Mean change from Baseline in daily reflective total ocular symptom score (rTOSS) over the entire treatment period

    		 Close Top of page
    End point title
    		 Mean change from Baseline in daily reflective total ocular symptom score (rTOSS) over the entire treatment period
    End point description
    TOSS is defined as the sum of the 3 individual ocular symptom scores for itching/burning eyes, tearing/watering eyes, and eye redness, and ranges from 0 to 9. Each symptom is scored on a 4 point (0 [none] to 3 [severe]) categorical scale. The rTOSS is a rating of the severity of symptoms over the previous 12 hours and is performed in AM and PM. Daily rTOSS is defined as average of the PM rTOSS and the AM rTOSS of the next day prior to AM dosing. The BL daily rTOSS is defined as the average of the daily rTOSS over 4 consecutive 24-hour periods prior to randomization plus randomization day AM assessment. Change from BL was calculated as average of the non-missing daily rTOSS minus BL daily rTOSS. Analysis was performed using ANCOVA, adjusting for BL value, country, age, and gender. Only those par. available at the specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 6
    End point values
    		 Placebo FF 110 µg QD
    Number of subjects analysed
    150 [23]
    150 [24]
    Units: Scores on a scale
        least squares mean (standard error)
    -1.41 ( 0.13 )
    -1.92 ( 0.13 )
    Notes
    [23] - ITT Population
    [24] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v FF 110 µg QD
    Number of subjects included in analysis
    300
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.004
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.506
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.85
         upper limit
    		 -0.16

    Secondary: Mean change from Baseline in AM pre-dose instantaneous TOSS (iTOSS) over the entire treatment period

    		 Close Top of page
    End point title
    		 Mean change from Baseline in AM pre-dose instantaneous TOSS (iTOSS) over the entire treatment period
    End point description
    TOSS is defined as the sum of the 3 individual ocular symptom scores for itching/burning eyes, tearing/watering eyes, and eye redness, and ranges from 0 to 9. Each symptom is scored on a 4 point (0 [none] to 3 [severe]) categorical scale. The AM pre-dose iTOSS is a rating of the severity of symptoms performed at the moment immediately prior to dosing. Baseline iTOSS is defined as the average of the non-missing values for iTOSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those par. available at the specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 6
    End point values
    		 Placebo FF 110 µg QD
    Number of subjects analysed
    149 [25]
    150 [26]
    Units: Scores on a scale
        least squares mean (standard error)
    -1.26 ( 0.13 )
    -1.76 ( 0.13 )
    Notes
    [25] - ITT Population
    [26] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v FF 110 µg QD
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.007
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.491
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.85
         upper limit
    		 -0.13

    Secondary: Mean Change from Baseline in AM rTOSS over the entire treatment period

    		 Close Top of page
    End point title
    		 Mean Change from Baseline in AM rTOSS over the entire treatment period
    End point description
    TOSS is defined as the sum of the 3 individual ocular symptom scores for itching/burning eyes, tearing/watering eyes, and eye redness, and ranges from 0 to 9. Each symptom is scored on a 4 point (0 [none] to 3 [severe]) categorical scale and larger score indicates more severe symptoms. The AM rTOSS is a rating of the severity of symptoms performed in the morning prior to administering the dose of study drug and assesses how the participant felt during the night (preceding 12 hours). Baseline rTOSS is defined as the average of the non-missing values for rTOSS during the Baseline period where the Baseline period includes the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those par. available at the specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 6
    End point values
    		 Placebo FF 110 µg QD
    Number of subjects analysed
    149 [27]
    150 [28]
    Units: Scores on a scale
        least squares mean (standard error)
    -1.39 ( 0.13 )
    -1.92 ( 0.13 )
    Notes
    [27] - ITT Population
    [28] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v FF 110 µg QD
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.003
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.531
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.88
         upper limit
    		 -0.19

    Secondary: Mean change from Baseline in PM rTOSS over the entire treatment period

    		 Close Top of page
    End point title
    		 Mean change from Baseline in PM rTOSS over the entire treatment period
    End point description
    TOSS is defined as the sum of the 3 individual ocular symptom scores for itching/burning eyes, tearing/watering eyes, and eye redness, and ranges from 0 to 9. Each symptom is scored on a 4 point (0 [none] to 3 [severe]) categorical scale. The PM rTOSS is a rating of the severity of symptoms performed approximately 12 hours after dosing and before bedtime and assesses how the participant felt during the day. Baseline rTOSS is defined as the average of the non-missing values for rTOSS during the Baseline period where the baseline period includes the 4 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those par. available at the specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 6
    End point values
    		 Placebo FF 110 µg QD
    Number of subjects analysed
    150 [29]
    150 [30]
    Units: Scores on a scale
        least squares mean (standard error)
    -1.44 ( 0.13 )
    -1.93 ( 0.13 )
    Notes
    [29] - ITT Population
    [30] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v FF 110 µg QD
    Number of subjects included in analysis
    300
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.005
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.496
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.84
         upper limit
    		 -0.15

    Secondary: Mean change from Baseline in daily reflective individual ocular symptom scores (IOSS) over the entire treatment period

    		 Close Top of page
    End point title
    		 Mean change from Baseline in daily reflective individual ocular symptom scores (IOSS) over the entire treatment period
    End point description
    individual ocular symptom scores (IOSS) for itching/burning eyes, tearing/watering eyes, and eye redness were assessed on a 4 point (0 [none]to 3 [severe]) categorical scale. The IOSS is a rating of the severity of symptoms over the previous 12 hours and is performed in AM and PM. Daily IOSS is defined as average of the PM IOSS and the AM IOSS of the next day prior to AM dosing. The BL daily IOSS is defined as the average of the daily IOSS over 4 consecutive 24-hour periods prior to randomization plus randomization day AM assessment. Change from BL was calculated as average of the non-missing daily IOSS minus BL daily IOSS. Analysis was performed using ANCOVA, adjusting for BL value, country, age, and gender. Only those par. available at the specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 6
    End point values
    		 Placebo FF 110 µg QD
    Number of subjects analysed
    150 [31]
    151 [32]
    Units: Scores on a scale
    least squares mean (standard error)
        Eye itching/burning
    -0.47 ( 0.05 )
    -0.69 ( 0.05 )
        Eye tearing/watering
    -0.48 ( 0.05 )
    -0.62 ( 0.05 )
        Eye redness
    -0.45 ( 0.04 )
    -0.61 ( 0.04 )
    Notes
    [31] - ITT Population
    [32] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    rIOSS for eye itching/burning
    Comparison groups
    Placebo v FF 110 µg QD
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.216
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.34
         upper limit
    		 -0.09
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    rIOSS for eye tearing/watering
    Comparison groups
    Placebo v FF 110 µg QD
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.028
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.137
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.26
         upper limit
    		 -0.02
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    rIOSS for eye redness
    Comparison groups
    Placebo v FF 110 µg QD
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.01
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.156
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.27
         upper limit
    		 -0.04

    Secondary: Mean change from Baseline in AM Pre-Dose instantaneous individual ocular sumptiom score (iIOSS) over the entire treatment period

    		 Close Top of page
    End point title
    		 Mean change from Baseline in AM Pre-Dose instantaneous individual ocular sumptiom score (iIOSS) over the entire treatment period
    End point description
    IOSS for itching/burning eyes, tearing/watering eyes, and eye redness were assessed on a 4 point (0 [none]to 3 [severe]) categorical scale. The AM pre-dose iIOSS is a rating of the severity of symptoms performed at the moment immediately prior to dosing. Baseline iIOSS is defined as the average of the non-missing values for iIOSS during the Baseline period where the Baseline period includes the randomization day and the 3 consecutive days prior to randomization. Change from Baseline is calculated as the score over the entire treatment period minus the score at Baseline. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those par. available at the specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 6
    End point values
    		 Placebo FF 110 µg QD
    Number of subjects analysed
    149 [33]
    150 [34]
    Units: Scores on a scale
    least squares mean (standard error)
        Eye itching/burning
    -0.39 ( 0.05 )
    -0.6 ( 0.05 )
        Eye tearing/watering
    -0.43 ( 0.05 )
    -0.59 ( 0.05 )
        Eye redness
    -0.45 ( 0.05 )
    -0.56 ( 0.05 )
    Notes
    [33] - ITT Population
    [34] - ITT Population
    Statistical analysis title
    		 Statistical analysis
    Statistical analysis description
    AM pre-dose iIOSS for eye itching/burning
    Comparison groups
    Placebo v FF 110 µg QD
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.002
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.215
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.35
         upper limit
    		 -0.08
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    AM pre-dose iIOSS for eye tearing/watering
    Comparison groups
    Placebo v FF 110 µg QD
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.016
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.161
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.29
         upper limit
    		 -0.03
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    AM pre-dose iIOSS for eye redness
    Comparison groups
    Placebo v FF 110 µg QD
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.076
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.113
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.24
         upper limit
    		 0.01

    Secondary: Mean change from Baseline in AM reflective individual ocular symptom score (rIOSS) over the entire treatment period

    		 Close Top of page
    End point title
    		 Mean change from Baseline in AM reflective individual ocular symptom score (rIOSS) over the entire treatment period
    End point description
    rIOSS for itching/burning eyes, tearing/watering eyes, and eye redness were assessed on a 4 point (0 [none]to 3 [severe]) categorical scale. The AM rIOSS is a rating of the severity of symptoms performed in the morning prior to administering the dose of study drug and assesses how the participant felt during the night (preceding 12 hours). Baseline rIOSS is defined as the average of the non-missing values for rIOSS during the Baseline period where the Baseline period includes the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those par. available at the specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 6
    End point values
    		 Placebo FF 110 µg QD
    Number of subjects analysed
    149 [35]
    150 [36]
    Units: Scores on a scale
    least squares mean (standard error)
        Eye itching/burning
    -0.48 ( 0.05 )
    -0.69 ( 0.05 )
        Eye tearing/watering
    -0.48 ( 0.05 )
    -0.62 ( 0.05 )
        Eye redness
    -0.44 ( 0.05 )
    -0.61 ( 0.05 )
    Notes
    [35] - ITT Population
    [36] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    AM rIOSS for eye itching/burning
    Comparison groups
    Placebo v FF 110 µg QD
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.211
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.34
         upper limit
    		 -0.08
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    AM rIOSS for eye tearing/watering
    Comparison groups
    Placebo v FF 110 µg QD
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.023
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.145
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.27
         upper limit
    		 -0.02
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    Placebo v FF 110 µg QD
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.005
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.176
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 -0.05

    Secondary: Mean change from Baseline in PM rIOSS over the entire treatment period

    		 Close Top of page
    End point title
    		 Mean change from Baseline in PM rIOSS over the entire treatment period
    End point description
    IOSS for itching/burning eyes, tearing/watering eyes, and eye redness were assessed on a 4 point (0 [none]to 3 [severe]) categorical scale. The PM rIOSS is a rating of the severity of symptoms performed approximately 12 hours after dosing and before bedtime and assesses how the participant felt during the day. Baseline rIOSS is defined as the average of the non-missing values for rIOSS during the Baseline period where the baseline period includes the 4 consecutive days prior to randomization. Change from Baseline is calculated as the score over the entire treatment period minus the score at Baseline. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those par. available at the specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 6
    End point values
    		 Placebo FF 110 µg QD
    Number of subjects analysed
    150 [37]
    150 [38]
    Units: Scores on a scale
    least squares mean (standard error)
        Eye itching/burning
    -0.47 ( 0.05 )
    -0.69 ( 0.05 )
        Eye tearing/watering
    -0.49 ( 0.05 )
    -0.62 ( 0.05 )
        Eye redness
    -0.47 ( 0.05 )
    -0.61 ( 0.05 )
    Notes
    [37] - ITT Population
    [38] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    PM rIOSS for eye itching/burning
    Comparison groups
    Placebo v FF 110 µg QD
    Number of subjects included in analysis
    300
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.223
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.35
         upper limit
    		 -0.09
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    PM rIOSS for eye tearing/watering
    Comparison groups
    Placebo v FF 110 µg QD
    Number of subjects included in analysis
    300
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.04
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.25
         upper limit
    		 -0.01
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    PM rIOSS for eye redness
    Comparison groups
    Placebo v FF 110 µg QD
    Number of subjects included in analysis
    300
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.022
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.142
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.26
         upper limit
    		 -0.02

    Secondary: Mean change from Baseline in daily peak nasal inspiratory flow (PNIF) over the entire treatment period

    		 Close Top of page
    End point title
    		 Mean change from Baseline in daily peak nasal inspiratory flow (PNIF) over the entire treatment period
    End point description
    PNIF is the tool for determining the extent of nasal airway obstruction. Participants used a portable hand-held inspiratory flow meter and face mask to measure and record PNIF. PNIF measurements was completed and recorded following assessment of allergy symptoms in the AM (prior to taking study medication), and 12 hours later in the PM (after recording allergy symptoms). Three measurements were taken and the highest measurement recorded on the electronic diary. Daily PNIF is defined as average of PM PNIF and AM PNIF of the next day prior to AM dosing. The BL is defined as average of the last 8 readings (4 AM and 4 PM) of PNIF measurement over the four 24-hour periods prior to randomization. Change from Baseline is calculated as the value over the entire treatment period minus the value at Baseline. Analysis was performed using ANCOVA, adjusting for BL value, country, age, and gender. Only those par. available at the specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 6
    End point values
    		 Placebo FF 110 µg QD
    Number of subjects analysed
    150 [39]
    151 [40]
    Units: Liter per minute
        least squares mean (standard error)
    17.35 ( 2.13 )
    25.72 ( 2.13 )
    Notes
    [39] - ITT Population
    [40] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v FF 110 µg QD
    Number of subjects included in analysis
    301
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.004
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    8.376
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.71
         upper limit
    		 14.04

    Secondary: Mean change from Baseline in AM PNIF over the entire treatment period

    		 Close Top of page
    End point title
    		 Mean change from Baseline in AM PNIF over the entire treatment period
    End point description
    PNIF is the tool for determining the extent of nasal airway obstruction. Participants used a portable hand-held inspiratory flow meter and face mask to measure and record PNIF. AM PNIF measurements was completed and recorded following assessment of allergy symptoms in the AM (prior to taking study medication). Three measurements were taken and the highest measurement recorded on the electronic diary. Baseline AM PNIF is defined as the average of the non-missing values for PNIF during the Baseline period where the Baseline period includes the randomization day and the 3 consecutive days prior to randomization. Change from Baseline is calculated as the value over the entire treatment period minus the value at Baseline. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those par. available at the specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 6
    End point values
    		 Placebo FF 110 µg QD
    Number of subjects analysed
    149 [41]
    151 [42]
    Units: Liter per minute
        least squares mean (standard error)
    16.33 ( 2.16 )
    25.61 ( 2.17 )
    Notes
    [41] - ITT Population
    [42] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v FF 110 µg QD
    Number of subjects included in analysis
    300
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.002
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    9.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.52
         upper limit
    		 15.04

    Secondary: Mean change from Baseline in PM PNIF over the entire treatment period

    		 Close Top of page
    End point title
    		 Mean change from Baseline in PM PNIF over the entire treatment period
    End point description
    PNIF is the tool for determining the extent of nasal airway obstruction. Participants used a portable hand-held inspiratory flow meter and face mask to measure and record PNIF. PM PNIF measurements was completed and recorded after assessment of allergy symptoms in the PM (12 hours after study medication). Three measurements were taken on each occasion and the highest measurement recorded on the electronic diary. Baseline PM PNIF is defined as the average of the non-missing values for PNIF during the Baseline period where the Baseline period includes the 4 consecutive days prior to randomization. Change from baseline is calculated as the value over the entire treatment period minus the value at Baseline. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those par. available at the specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 6
    End point values
    		 Placebo FF 110 µg QD
    Number of subjects analysed
    150 [43]
    147 [44]
    Units: Liter per minute
        least squares mean (standard error)
    18.51 ( 2.15 )
    26.15 ( 2.2 )
    Notes
    [43] - ITT Population
    [44] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v FF 110 µg QD
    Number of subjects included in analysis
    297
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.009
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    7.638
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.89
         upper limit
    		 13.39

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment until follow-up period (Up to 48 days).
    Adverse event reporting additional description
    SAEs and non-serious AEs were reported for members of the ITT population, comprised of all participants who were randomised to treatment, and received at least one dose of study medication.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    9.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a blinded matching placebo aqueous nasal spray once daily (QD) every morning for 6 weeks. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days.

    Reporting group title
    FF 110 µg QD
    Reporting group description
    		 Participants received a blinded fluticasone furoate (FF) aqueous nasal spray 110 microgram (µg) QD every morning for 6 weeks. Dose was administered by alternately spraying one spray (27.5 µg per spray) into each nostril followed by a second spray into each nostril for 42 days.

    Serious adverse events
    		 Placebo FF 110 µg QD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 151 (0.00%)
    1 / 151 (0.66%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    0 / 151 (0.00%)
    1 / 151 (0.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Placebo FF 110 µg QD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    48 / 151 (31.79%)
    57 / 151 (37.75%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 151 (0.66%)
    4 / 151 (2.65%)
         occurrences all number
    1
    4
    Headache
         subjects affected / exposed
    29 / 151 (19.21%)
    27 / 151 (17.88%)
         occurrences all number
    49
    46
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 151 (0.66%)
    4 / 151 (2.65%)
         occurrences all number
    1
    4
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 151 (3.31%)
    2 / 151 (1.32%)
         occurrences all number
    5
    3
    Epistaxis
         subjects affected / exposed
    6 / 151 (3.97%)
    13 / 151 (8.61%)
         occurrences all number
    7
    20
    Nasal septum ulceration
         subjects affected / exposed
    0 / 151 (0.00%)
    4 / 151 (2.65%)
         occurrences all number
    0
    5
    Pharyngolaryngeal pain
         subjects affected / exposed
    6 / 151 (3.97%)
    13 / 151 (8.61%)
         occurrences all number
    9
    16
    Skin and subcutaneous tissue disorders
    Scab
         subjects affected / exposed
    1 / 151 (0.66%)
    4 / 151 (2.65%)
         occurrences all number
    1
    4
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    7 / 151 (4.64%)
    9 / 151 (5.96%)
         occurrences all number
    10
    9
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 151 (3.97%)
    3 / 151 (1.99%)
         occurrences all number
    6
    3

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Nov 2005
    removed the use of an Independent Data Monitoring Committee in this study, which has been included in error in the original protocol
    14 Feb 2006
    allowed the collection of nasal cytology samples at Early Withdrawal Visits (US and Canada only), added a requirement for subjects to be 18 years of age or older at Visit 1 (Germany only), corrected typographical errors on the cover sheet of Amendment 1, and made other minor text corrections in the protocol

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun May 04 14:23:41 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA