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    Clinical Trial Results:
    Study FFU109045, A Comparison of Fluticasone Furoate Nasal Spray versus Oral Fexofenadine in the Treatment of Seasonal Allergic Rhinitis

    Summary
    EudraCT number
    		 2015-004885-27
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    28 Feb 2007

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Dec 2016
    First version publication date
    29 Dec 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    FFU109045
    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
    25 Apr 2007
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Feb 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that Fluticasone furoate nasal spray (FFNS) provides superior nighttime symptom relief compared to fexofenadine as determined by the mean change from baseline in the nighttime nasal symptoms score (NSS)
    Protection of trial subjects
    Not applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Dec 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
    United States: 936
    Worldwide total number of subjects
    936
    EEA total number of subjects
    0
    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)
    81
    Adults (18-64 years)
    831
    From 65 to 84 years
    24
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study included 5-21 days of screening period followed by two weeks of treatment period and a Follow-up. Participants had to meet five symptom assessment criteria before randomization. Two of these were based on the average Nasal Symptom Score (NSS) assessment and three criteria’s were based on the Daytime reflective Nasal Symptom Score D-rTNSS.

    Pre-assignment
    Screening details
    		 Total of 1360 participants were planned for enrollment so as to have 951 evaluable participants. A total of 1338 participants were screened and 936 were randomized.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants received vehicle placebo nasal spray and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo capsule each morning once daily for two weeks following pre-dose symptom assessment.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    Placebo nasal spray each morning once daily for two weeks following pre-dose symptom assessment.

    Arm title
    		 FFNS 110 microgram (mcg)
    Arm description
    		 Participants received fluticasone fuorate nasal spray (FFNS) 110 mcg and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment.
    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
    110 µg nasal spray each morning once daily for two weeks following pre-dose symptom assessment.

    Arm title
    		 Fex 180 milligram (mg)
    Arm description
    		 Participants received oral capsule (overencapsulated fexofenadine [Fex] 180 mg oral tablet) and vehicle placebo nasal spray each morning once daily for two weeks following pre-dose symptom assessment.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Fexofenadine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Oral capsule (over encapsulated fexofenadine 180 mg oral tablet) each morning once daily for two weeks following pre-dose symptom assessment.

    Number of subjects in period 1
    		Placebo FFNS 110 microgram (mcg) Fex 180 milligram (mg)
    Started
    313
    312
    311
    Completed
    290
    298
    287
    Not completed
    23
    14
    24
         Randomized in error
    1
    -
    -
         Subject ended study one day early
    1
    -
    -
         Subject could not tolerate symptoms
    -
    -
    1
         Compliance less than 80 percent
    1
    -
    -
         subject could not swallow capsule
    -
    -
    1
         Visit changed to EarlyWithdrawn Visit
    1
    -
    -
         noncompliance with study requirements
    1
    1
    1
         Consent withdrawn by subject
    1
    -
    2
         Adverse event, non-fatal
    1
    2
    6
         Non-Compliance of diary
    2
    -
    1
         Pregnancy
    2
    -
    -
         In error, two study medications switched
    1
    -
    -
         Subject randomized with inadequate score
    1
    -
    -
         Subject moved eDiary and studymedication
    1
    -
    -
         Lost to follow-up
    1
    1
    2
         Protocol deviation
    6
    9
    10
         Lack of efficacy
    2
    1
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received vehicle placebo nasal spray and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment.

    Reporting group title
    FFNS 110 microgram (mcg)
    Reporting group description
    		 Participants received fluticasone fuorate nasal spray (FFNS) 110 mcg and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment.

    Reporting group title
    Fex 180 milligram (mg)
    Reporting group description
    		 Participants received oral capsule (overencapsulated fexofenadine [Fex] 180 mg oral tablet) and vehicle placebo nasal spray each morning once daily for two weeks following pre-dose symptom assessment.

    Reporting group values
    		 Placebo FFNS 110 microgram (mcg) Fex 180 milligram (mg) Total
    Number of subjects
    		 313 312 311
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 37.8 ( 14.39 ) 37.8 ( 13.95 ) 39.6 ( 14.63 ) -
    Gender categorical
    Units:
        Female
    		 194 209 199 602
        Male
    		 119 103 112 334
    Race, Customized
    Units: Subjects
        African American/African Heritage
    		 22 26 9 57
        American Indian or Alaska Native
    		 7 5 6 18
        Asian - Central/South Asian Heritage
    		 3 1 1 5
        Asian - East Asian Heritage
    		 1 2 0 3
        Asian - Japanese Heritage
    		 0 1 0 1
        Asian - South East Asian Heritage
    		 2 1 2 5
        Native Hawaiian or other Pacific Islander
    		 2 1 2 5
        White/Caucasian/European Heritage
    		 270 268 286 824
        Mixed Race
    		 6 7 5 18

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received vehicle placebo nasal spray and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment.

    Reporting group title
    FFNS 110 microgram (mcg)
    Reporting group description
    		 Participants received fluticasone fuorate nasal spray (FFNS) 110 mcg and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment.

    Reporting group title
    Fex 180 milligram (mg)
    Reporting group description
    		 Participants received oral capsule (overencapsulated fexofenadine [Fex] 180 mg oral tablet) and vehicle placebo nasal spray each morning once daily for two weeks following pre-dose symptom assessment.

    Primary: Mean change from Baseline over the two-week treatment period in Nighttime Symptoms Score (NSS)

    		 Close Top of page
    End point title
    		 Mean change from Baseline over the two-week treatment period in Nighttime Symptoms Score (NSS)
    End point description
    The NSS is a three-item questionnaire which assesses three aspects of allergic rhinitis symptoms at night: (PM nasal congestion upon awakening [PMNCA], difficulty in going to sleep due to nasal symptoms [DSNS], and nighttime awakenings due to nasal symptoms [NANS]). These symptoms were rated using three 4-point scales, the sum of which comprises NSS. Each participant's baseline NSS was defined as the average of the NSS calculated for the day of randomization and the three highest NSS scores calculated during the six days immediately prior to the day of randomization. Each participant's average change from baseline NSS for Weeks 1-2 was the participant's average NSS over the treatment period minus the participant's baseline NSS. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Primary
    End point timeframe
    Baseline and up to 2 weeks
    End point values
    		 Placebo FFNS 110 microgram (mcg) Fex 180 milligram (mg)
    Number of subjects analysed
    313 [1]
    312
    311
    Units: Scores on a scale
    arithmetic mean (standard error)
        NSS, Week 1-2, n=312, 312, 309
    -1.9 ( 0.1 )
    -2.9 ( 0.1 )
    -2 ( 0.09 )
        PMNCA, Week 1-2, n=312, 312, 309
    -0.6 ( 0.03 )
    -0.9 ( 0.03 )
    -0.6 ( 0.03 )
        NANS, Week 1-2, n=312, 312, 309
    -0.7 ( 0.04 )
    -1 ( 0.04 )
    -0.7 ( 0.03 )
        DSNS, Week 1-2, n=312, 312, 309
    -0.7 ( 0.04 )
    -1.1 ( 0.04 )
    -0.8 ( 0.04 )
    Notes
    [1] - Intent To Treat (ITT) Population: Included all participants randomized to double-blind treatment.
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    FFNS 110 microgram (mcg) v Fex 180 milligram (mg)
    Number of subjects included in analysis
    623
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.2
         upper limit
    		 -0.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Placebo v FFNS 110 microgram (mcg)
    Number of subjects included in analysis
    625
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.2
         upper limit
    		 -0.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Placebo v Fex 180 milligram (mg)
    Number of subjects included in analysis
    624
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.816
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 0.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14

    Secondary: Mean change from Baseline over the two-week treatment period in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) and Component Nasal Symtoms Score

    		 Close Top of page
    End point title
    		 Mean change from Baseline over the two-week treatment period in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) and Component Nasal Symtoms Score
    End point description
    The nighttime reflective assessments were recorded each morning and assessed the four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing) over the previous 12 hours (evening and night). The scores of each of the four nighttime symptoms were summed for each participant to create a N-rTNSS for each day. Each participant's baseline total symptom score was the average of the nighttime total symptom score on the day of randomization and the three highest scores calculated for the six days immediately prior to the day of randomization. Each participant's average change from baseline nighttime total symptom score for Weeks 1-2 was the participant's average Nighttime total symptom score over the treatment period minus the participant's baseline score. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline and up to 2 weeks
    End point values
    		 Placebo FFNS 110 microgram (mcg) Fex 180 milligram (mg)
    Number of subjects analysed
    313 [2]
    312
    311
    Units: Scores on a scale
    arithmetic mean (standard error)
        TNSS, n=312, 312, 309
    -2.5 ( 0.13 )
    -3.7 ( 0.14 )
    -2.7 ( 0.13 )
        Nasal congestion, n=312, 312, 309
    -0.6 ( 0.03 )
    -0.9 ( 0.04 )
    -0.7 ( 0.03 )
        Itchy nose, n=312, 312, 309
    -0.7 ( 0.04 )
    -0.9 ( 0.04 )
    -0.7 ( 0.04 )
        Runny nose, n=312, 312, 309
    -0.6 ( 0.04 )
    -0.9 ( 0.04 )
    -0.7 ( 0.03 )
        Sneezing, n=312, 312, 309
    -0.7 ( 0.04 )
    -1 ( 0.04 )
    -0.7 ( 0.04 )
    Notes
    [2] - ITT population
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v FFNS 110 microgram (mcg)
    Number of subjects included in analysis
    625
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 -0.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.18
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Placebo v Fex 180 milligram (mg)
    Number of subjects included in analysis
    624
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.136
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.6
         upper limit
    		 0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.18
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    FFNS 110 microgram (mcg) v Fex 180 milligram (mg)
    Number of subjects included in analysis
    623
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 -0.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.18

    Secondary: Mean change from Baseline over the two-week treatment period in Daytime Reflective Total Nasal Symptom Scores (D-rTNSS)

    		 Close Top of page
    End point title
    		 Mean change from Baseline over the two-week treatment period in Daytime Reflective Total Nasal Symptom Scores (D-rTNSS)
    End point description
    The Daytime reflective assessments were recorded each evening and assessed the four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing) over the previous 12 hours (evening and night). The scores of each of the four Daytime symptoms were summed for each participant to create a D-rTNSS for each day. Each participant's baseline total symptom score was the average of the four highest total symptom score calculated for the seven days immediately prior to the day of randomization. Each participant's average change from baseline Daytime total symptom score for Weeks 1-2 was the participant's average Daytime total symptom score over the treatment period minus the participants baseline score. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline and up to 2 weeks
    End point values
    		 Placebo FFNS 110 microgram (mcg) Fex 180 milligram (mg)
    Number of subjects analysed
    313 [3]
    312
    311
    Units: Scores on a scale
    arithmetic mean (standard error)
        TNSS n=312, 312, 309
    -2.6 ( 0.13 )
    -3.7 ( 0.14 )
    -3 ( 0.13 )
        Nasal congestion, n=312, 312, 309
    -0.7 ( 0.04 )
    -0.9 ( 0.04 )
    -0.8 ( 0.03 )
        Itchy nose, n=312, 312, 309
    -0.7 ( 0.04 )
    -1 ( 0.04 )
    -0.8 ( 0.04 )
        Runny nose, n=312, 312, 309
    -0.6 ( 0.04 )
    -0.9 ( 0.04 )
    -0.7 ( 0.03 )
        Sneezing, n=312, 312, 309
    -0.7 ( 0.04 )
    -1.1 ( 0.04 )
    -0.9 ( 0.04 )
    Notes
    [3] - ITT population
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v FFNS 110 microgram (mcg)
    Number of subjects included in analysis
    625
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.5
         upper limit
    		 -0.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.19
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Placebo v Fex 180 milligram (mg)
    Number of subjects included in analysis
    624
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.136
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.19
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    FFNS 110 microgram (mcg) v Fex 180 milligram (mg)
    Number of subjects included in analysis
    623
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.2
         upper limit
    		 -0.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.19

    Secondary: Mean change from Baseline over the two-week treatment period in 24-hour Reflective Total Nasal Symptom Scores (24-hour rTNSS) and Component Nasal Score.

    		 Close Top of page
    End point title
    		 Mean change from Baseline over the two-week treatment period in 24-hour Reflective Total Nasal Symptom Scores (24-hour rTNSS) and Component Nasal Score.
    End point description
    Daily 24-hour rTNSS was calculated as the average of the corresponding N-rTNSS and D-rTNSS. The 24-hour total symptom score for a Day is the average of the daytime total symptom score for that Day and the nighttime score for (D+1). If either component of a given date’s 24-hour total symptom score was missing, then the 24-hour total symptom score itself were to be set to missing. Each participant's average change from baseline 24-hour total symptom score for Weeks 1-2 was the participants average 24-hour total symptom score over the treatment period minus the participant's baseline score. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline and up to 2 weeks
    End point values
    		 Placebo FFNS 110 microgram (mcg) Fex 180 milligram (mg)
    Number of subjects analysed
    313 [4]
    312
    311
    Units: Scores on a scale
    arithmetic mean (standard error)
        TNSS, n=312, 312, 308
    -2.5 ( 0.13 )
    -3.6 ( 0.14 )
    -2.8 ( 0.13 )
        Nasal congestion, n=312, 312, 308
    -0.6 ( 0.03 )
    -0.9 ( 0.04 )
    -0.7 ( 0.03 )
        Itchy nose, n=312, 312, 308
    -0.7 ( 0.04 )
    -0.9 ( 0.04 )
    -0.8 ( 0.04 )
        Runny nose, n=312, 312, 308
    -0.6 ( 0.03 )
    -0.9 ( 0.04 )
    -0.7 ( 0.03 )
        Sneezing, n=312, 312, 308
    -0.7 ( 0.04 )
    -1 ( 0.04 )
    -0.8 ( 0.04 )
    Notes
    [4] - ITT population
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v FFNS 110 microgram (mcg)
    Number of subjects included in analysis
    625
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 -0.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.18
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    FFNS 110 microgram (mcg) v Fex 180 milligram (mg)
    Number of subjects included in analysis
    623
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 -0.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.18
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Placebo v Fex 180 milligram (mg)
    Number of subjects included in analysis
    624
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.136
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.6
         upper limit
    		 0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.18

    Secondary: Mean change from Baseline over the two-week treatment period in Nighttime Reflective Total Ocular Symptom Scores (N-rTOSS)

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    End point title
    		 Mean change from Baseline over the two-week treatment period in Nighttime Reflective Total Ocular Symptom Scores (N-rTOSS)
    End point description
    The nighttime reflective assessments were recorded each morning and assessed the three ocular symptoms (tearing/watering, itching/burning, and redness) over the previous 12 hours (evening and night). The scores of each of the three Nighttime symptoms were summed for each participant to create a N-rTOSS for each day. Each participants baseline total symptom score was the average of the nighttime total symptom score on the day of randomization and the three highest scores calculated for the six days immediately prior to the day of randomization. Each participant's average change from baseline nighttime total symptom score for Weeks 1-2 was the participant's average Nighttime total symptom score over the treatment period minus the participant's baseline score. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline and up to 2 weeks
    End point values
    		 Placebo FFNS 110 microgram (mcg) Fex 180 milligram (mg)
    Number of subjects analysed
    313 [5]
    312
    311
    Units: Scores on a scale
    arithmetic mean (standard error)
        TOSS n=312, 312, 309
    -2 ( 0.11 )
    -2.5 ( 0.11 )
    -2.2 ( 0.11 )
        Eye tearing, n=312, 312, 309
    -0.7 ( 0.04 )
    -0.9 ( 0.04 )
    -0.8 ( 0.04 )
        Eye itching, n=312, 312, 309
    -0.7 ( 0.04 )
    -0.9 ( 0.04 )
    -0.8 ( 0.04 )
        Eye redness, n=312, 312, 309
    -0.6 ( 0.04 )
    -0.8 ( 0.04 )
    -0.7 ( 0.04 )
    Notes
    [5] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v FFNS 110 microgram (mcg)
    Number of subjects included in analysis
    625
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8
         upper limit
    		 -0.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.15
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    FFNS 110 microgram (mcg) v Fex 180 milligram (mg)
    Number of subjects included in analysis
    623
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.106
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.6
         upper limit
    		 0
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.15
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Placebo v Fex 180 milligram (mg)
    Number of subjects included in analysis
    624
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.286
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.15

    Secondary: Mean change from Bbaseline over the two-week treatment period in Daytime Reflective Total Ocular Symptom Scores (D-rTOSS)

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    End point title
    		 Mean change from Bbaseline over the two-week treatment period in Daytime Reflective Total Ocular Symptom Scores (D-rTOSS)
    End point description
    The Daytime reflective assessments were recorded each evening and assessed the three nasal symptoms (tearing/watering, itching/burning, and redness) over the previous 12 hours (evening and night). The scores of each of the three Daytime symptoms were summed for each participant to create a D-rTOSS for each day. Each participants baseline total symptom score was the average of the four highest total symptom score calculated for the seven days immediately prior to the day of randomization. Each participant's average change from baseline Daytime total symptom score for Weeks 1-2 was the participant's average Daytime total symptom score over the treatment period minus the participant's baseline score. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline and up to 2 weeks
    End point values
    		 Placebo FFNS 110 microgram (mcg) Fex 180 milligram (mg)
    Number of subjects analysed
    313 [6]
    312
    311
    Units: Scores on a scale
    arithmetic mean (standard error)
        TOSS n=312, 312, 309
    -2.2 ( 0.11 )
    -2.6 ( 0.11 )
    -2.4 ( 0.11 )
        Eye tearing, n=312, 312, 309
    -0.8 ( 0.04 )
    -0.9 ( 0.04 )
    -0.8 ( 0.04 )
        Eye itching, n=312, 312, 309
    -0.8 ( 0.04 )
    -0.9 ( 0.04 )
    -0.9 ( 0.04 )
        Eye redness, n=312, 312, 309
    -0.7 ( 0.04 )
    -0.8 ( 0.04 )
    -0.7 ( 0.04 )
    Notes
    [6] - ITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v FFNS 110 microgram (mcg)
    Number of subjects included in analysis
    625
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.007
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 -0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.15
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Placebo v Fex 180 milligram (mg)
    Number of subjects included in analysis
    624
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.286
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.15
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    FFNS 110 microgram (mcg) v Fex 180 milligram (mg)
    Number of subjects included in analysis
    623
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.106
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.15

    Secondary: Mean change from Baseline over the two-week treatment period in 24-hour Reflective Total Ocular Symptom Scores (24-hour rTOSS)

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    End point title
    		 Mean change from Baseline over the two-week treatment period in 24-hour Reflective Total Ocular Symptom Scores (24-hour rTOSS)
    End point description
    Daily 24-hour rTOSS was calculated as the average of the corresponding N-rTOSS and D-rTOSS. The 24-hour total symptom score for a Day is the average of the daytime total symptom score for that Day and the nighttime score for (D+1). If either component of a given date’s 24-hour total symptom score was missing, then the 24-hour total symptom score itself was to be set to missing. Each participant's average change from baseline 24-hour total symptom score for Weeks 1-2 was the participant's average 24-hour total symptom score over the treatment period minus the participant's baseline score. Baseline is the 4 highest scores calculated for the 7 days prior to Day 1. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline and up to 2 weeks
    End point values
    		 Placebo FFNS 110 microgram (mcg) Fex 180 milligram (mg)
    Number of subjects analysed
    313 [7]
    312
    311
    Units: Scores on a scale
    arithmetic mean (standard error)
        TOSS n=312, 312, 308
    -2 ( 0.11 )
    -2.5 ( 0.11 )
    -2.2 ( 0.11 )
        Eye tearing, n=312, 312, 308
    -0.7 ( 0.04 )
    -0.9 ( 0.04 )
    -0.8 ( 0.04 )
        Eye itching, n=312, 312, 308
    -0.7 ( 0.04 )
    -0.9 ( 0.04 )
    -0.8 ( 0.04 )
        Eye redness, n=312, 312, 308
    -0.7 ( 0.04 )
    -0.8 ( 0.04 )
    -0.7 ( 0.04 )
    Notes
    [7] - ITT Population
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v FFNS 110 microgram (mcg)
    Number of subjects included in analysis
    625
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.003
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 -0.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.15
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Placebo v Fex 180 milligram (mg)
    Number of subjects included in analysis
    624
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.286
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.15
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    FFNS 110 microgram (mcg) v Fex 180 milligram (mg)
    Number of subjects included in analysis
    623
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.106
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.6
         upper limit
    		 0
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.15

    Secondary: Mean change from Baseline over the two-week treatment period in Pre-dose Instantaneous Total Nasal Symptom Score (Pre-dose iTNSS) and Pre-dose Instantaneous Total Ocular Symptom Scores (Pre-dose iTOSS)

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    End point title
    		 Mean change from Baseline over the two-week treatment period in Pre-dose Instantaneous Total Nasal Symptom Score (Pre-dose iTNSS) and Pre-dose Instantaneous Total Ocular Symptom Scores (Pre-dose iTOSS)
    End point description
    Participants were instructed to score and document their symptoms in an instantaneous manner on a diary card. The instantaneous rating was performed once daily just prior to administering their morning dose. The scores of each of the three instantaneous nasal symptoms (nasal congestion, itching, rhinorrhea, and sneezing) and ocular symptoms (tearing/watering, itching/burning, and redness) were summed for each participant to create a iTNSS and iTOSS, respectively. Each participant's average change from Baseline iTNSS and iTOSS was the participant's average iTNSS and iTOSS total symptom score over the treatment period minus the participant's baseline score. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline and up to 2 weeks
    End point values
    		 Placebo FFNS 110 microgram (mcg) Fex 180 milligram (mg)
    Number of subjects analysed
    313 [8]
    312
    311
    Units: Score on a scale
    arithmetic mean (standard error)
        TNSS, n=312, 312, 309
    -2.3 ( 0.13 )
    -3.6 ( 0.14 )
    -2.6 ( 0.12 )
        Pre-dose iTNSS, Nasal congestion n=312, 312, 309
    -0.6 ( 0.03 )
    -0.8 ( 0.03 )
    -0.6 ( 0.03 )
        Pre-dose iTNSS, Itchy nose n=312, 312, 309
    -0.7 ( 0.04 )
    -1 ( 0.04 )
    -0.7 ( 0.04 )
        Pre-dose iTNSS, Runny nose n=312, 312, 309
    -0.6 ( 0.04 )
    -0.9 ( 0.04 )
    -0.6 ( 0.04 )
        Pre-dose iTNSS, Sneezing n=312, 312, 309
    -0.7 ( 0.04 )
    -1 ( 0.04 )
    -0.7 ( 0.04 )
        TOSS, n=312, 312, 309
    -1.9 ( 0.11 )
    -2.4 ( 0.12 )
    -2.2 ( 0.1 )
        Pre-dose iTOSS, Eye tearing, n=312, 312, 309
    -0.7 ( 0.04 )
    -0.9 ( 0.04 )
    -0.8 ( 0.04 )
        Pre-dose iTOSS, Eye itching, n=312, 312, 309
    -0.7 ( 0.04 )
    -0.9 ( 0.04 )
    -0.8 ( 0.04 )
        Pre-dose iTOSS, Eye redness, n=312, 312, 309
    -0.6 ( 0.04 )
    -0.8 ( 0.04 )
    -0.7 ( 0.04 )
    Notes
    [8] - ITT Population
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Pre-dose iTNSS
    Comparison groups
    Placebo v FFNS 110 microgram (mcg)
    Number of subjects included in analysis
    625
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.7
         upper limit
    		 -1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.18
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Pre-dose iTNSS
    Comparison groups
    FFNS 110 microgram (mcg) v Fex 180 milligram (mg)
    Number of subjects included in analysis
    623
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 -0.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.18
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Pre-dose iTNSS
    Comparison groups
    Placebo v Fex 180 milligram (mg)
    Number of subjects included in analysis
    624
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.193
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.6
         upper limit
    		 0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.18
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    Pre-dose iTOSS
    Comparison groups
    Placebo v FFNS 110 microgram (mcg)
    Number of subjects included in analysis
    625
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8
         upper limit
    		 -0.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.15
    Statistical analysis title
    		 Statistical Analysis 5
    Statistical analysis description
    Pre-dose iTOSS
    Comparison groups
    FFNS 110 microgram (mcg) v Fex 180 milligram (mg)
    Number of subjects included in analysis
    623
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.058
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.6
         upper limit
    		 0
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.15
    Statistical analysis title
    		 Statistical Analysis 6
    Statistical analysis description
    Pre-dose iTOSS
    Comparison groups
    Placebo v Fex 180 milligram (mg)
    Number of subjects included in analysis
    624
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.16
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 0
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.15

    Secondary: Mean change from Baseline over the two-week treatment period in Peak NasalIinspiratory Flow (PNIF)

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    End point title
    		 Mean change from Baseline over the two-week treatment period in Peak NasalIinspiratory Flow (PNIF)
    End point description
    PNIF was measured by participants using an In-Check Nasal portable hand-held inspiratory flow meter and face mask. Participants recorded PNIF twice daily (in the morning prior to taking their study medication and in the evening). Three measurements were taken on each occasion and the highestmeasurement recorded on the electronic diary. Each participant's average change from Baseline PNIF was the participant's average PNIF over the treatment period minus the participant's baseline PNIF. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline and up to 2 weeks
    End point values
    		 Placebo FFNS 110 microgram (mcg) Fex 180 milligram (mg)
    Number of subjects analysed
    313 [9]
    312
    311
    Units: Liter(L)/minute (min)
    arithmetic mean (standard error)
        Morning PNIF n=312, 312, 308
    1.7 ( 0.99 )
    9.9 ( 1.28 )
    1.4 ( 1.18 )
        Evening PNIF n=312, 311, 308
    0.2 ( 1.12 )
    7.1 ( 1.31 )
    1.3 ( 1.23 )
    Notes
    [9] - ITT Population
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Morning assessment
    Comparison groups
    FFNS 110 microgram (mcg) v Fex 180 milligram (mg)
    Number of subjects included in analysis
    623
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    8.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.7
         upper limit
    		 11.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.59
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Morning assessment
    Comparison groups
    Placebo v FFNS 110 microgram (mcg)
    Number of subjects included in analysis
    625
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    8.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.3
         upper limit
    		 11.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.59
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Morning assessment
    Comparison groups
    Placebo v Fex 180 milligram (mg)
    Number of subjects included in analysis
    624
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.779
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.6
         upper limit
    		 2.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.59
    Statistical analysis title
    		 Statistical Analysis 4
    Statistical analysis description
    Evening assessment
    Comparison groups
    FFNS 110 microgram (mcg) v Fex 180 milligram (mg)
    Number of subjects included in analysis
    623
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    6.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.1
         upper limit
    		 9.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.65
    Statistical analysis title
    		 Statistical Analysis 5
    Statistical analysis description
    Evening assessment
    Comparison groups
    Placebo v FFNS 110 microgram (mcg)
    Number of subjects included in analysis
    625
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.8
         upper limit
    		 10.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.65
    Statistical analysis title
    		 Statistical Analysis 6
    Statistical analysis description
    Evening assessment
    Comparison groups
    Placebo v Fex 180 milligram (mg)
    Number of subjects included in analysis
    624
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.662
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.5
         upper limit
    		 4
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.65

    Secondary: Mean change from Baseline for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)

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    End point title
    		 Mean change from Baseline for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)
    End point description
    The NRQLQ is a paper instrument administered on the day of randomization and at Visit 4/Early Withdrawal to assess nocturnal rhinitis-related quality of life. The NRQLQ is a 16-item, self-administered, disease-specific (allergic rhinitis), and quality of life instrument that measures the functional problems most troublesome to patients with nocturnal allergy symptoms over a one-week interval. Each question is scored from 0 to 6 with higher scores indicating more nocturnal impairment. Items are grouped into four domains: Sleep problems, Sleep time problems, Symptoms on waking in the morning and Practical problems.An overall score was calculated from the mean score of all items. Each participant's average change from Baseline NRQLQ score was the participant's average NRQLQ score over the treatment period minus the participant's baseline score. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline and Day 15
    End point values
    		 Placebo FFNS 110 microgram (mcg) Fex 180 milligram (mg)
    Number of subjects analysed
    313 [10]
    312
    311
    Units: Scores on a scale
    arithmetic mean (standard error)
        Overall score, n=308, 309, 304
    -1.3 ( 0.08 )
    -1.9 ( 0.09 )
    -1.5 ( 0.08 )
        Sleep problems, n=308, 311, 305
    -1.2 ( 0.09 )
    -1.9 ( 0.09 )
    -1.5 ( 0.09 )
        Sleep time problems, n=308, 311, 305
    -1.3 ( 0.09 )
    -1.9 ( 0.09 )
    -1.5 ( 0.09 )
        Symptoms on waking, n=308, 309, 304
    -1.4 ( 0.09 )
    -2 ( 0.1 )
    -1.5 ( 0.09 )
        Practicle problems, n=308, 309, 304
    -1.2 ( 0.09 )
    -1.9 ( 0.1 )
    -1.6 ( 0.1 )
    Notes
    [10] - ITT Population
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    FFNS 110 microgram (mcg) v Fex 180 milligram (mg)
    Number of subjects included in analysis
    623
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 -0.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.11
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Placebo v Fex 180 milligram (mg)
    Number of subjects included in analysis
    624
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.203
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.4
         upper limit
    		 0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.11
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Placebo v FFNS 110 microgram (mcg)
    Number of subjects included in analysis
    625
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8
         upper limit
    		 -0.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.11

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events (AEs) and Serious adverse events (SAEs) were collected from the time the first dose of study medication until the follow up contact (Up to Day 20)
    Adverse event reporting additional description
    SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    9.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received vehicle placebo nasal spray and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment.

    Reporting group title
    Fex 180 milligram (mg)
    Reporting group description
    		 Participants received oral capsule (overencapsulated fexofenadine [Fex] 180 mg oral tablet) and vehicle placebo nasal spray each morning once daily for two weeks following pre-dose symptom assessment.

    Reporting group title
    FFNS 110 microgram (mcg)
    Reporting group description
    		 Participants received fluticasone fuorate nasal spray (FFNS) 110 mcg and oral placebo capsule each morning once daily for two weeks following pre-dose symptom assessment.

    Serious adverse events
    		 Placebo Fex 180 milligram (mg) FFNS 110 microgram (mcg)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 311 (0.32%)
    0 / 312 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 311 (0.32%)
    0 / 312 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Placebo Fex 180 milligram (mg) FFNS 110 microgram (mcg)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 313 (3.51%)
    10 / 311 (3.22%)
    12 / 312 (3.85%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    11 / 313 (3.51%)
    10 / 311 (3.22%)
    12 / 312 (3.85%)
         occurrences all number
    13
    11
    14

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Dec 2006
    (1) permitted visit windows for Visits 3 and 4 that accommodated the Monday holidays which occurred during the study period, (2) permitted the use of the estrogenic vaginal ring as an acceptable method of birth control, and (3) provided a criterion for unacceptable diary compliance for the treatment period.

    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
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