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    Clinical Trial Results:
    A randomized, double-blind, placebo controlled, parallel group, multi-centre, 2-week treatment study to evaluate the safety and efficacy of fluticasone furoate nasal spray (FFNS) 110 mcg, administered either once daily or twice daily, compared with placebo, as effective monotherapy in the treatment of uncomplicated acute rhinosinusitis (ARS) in adult and adolescent subjects 12 years of age and older.

    Summary
    EudraCT number
    		 2009-015014-22
    Trial protocol
    		 EE   NL   NO   SE   ES   DE   PL   CZ   BG  
    Global end of trial date
    16 Jul 2010

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

    Trial information

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    Trial identification
    Sponsor protocol code
    FFS113203
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01018030
    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, GSK Response Center, 1 866-435-7343,
    Scientific contact
    GSK Response Center, GSK Response Center, 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
    09 Sep 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Jul 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study is to evaluate the safety and efficacy of two doses of FFNS (110 mcg once daily and 110 mcg twice daily) compared to placebo as monotherapy in the treatment of adult and adolescent subjects 12 years of age and older with uncomplicated ARS.
    Protection of trial subjects
    Safety monitoring included monitoring for adverse events, clinical laboratory tests, vital signs, and nasal examinations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Jan 2010
    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
    Netherlands: 40
    Country: Number of subjects enrolled
    Norway: 24
    Country: Number of subjects enrolled
    Poland: 58
    Country: Number of subjects enrolled
    Spain: 24
    Country: Number of subjects enrolled
    Sweden: 34
    Country: Number of subjects enrolled
    Bulgaria: 104
    Country: Number of subjects enrolled
    Czech Republic: 26
    Country: Number of subjects enrolled
    Estonia: 39
    Country: Number of subjects enrolled
    Germany: 157
    Country: Number of subjects enrolled
    Canada: 123
    Country: Number of subjects enrolled
    Russian Federation: 55
    Country: Number of subjects enrolled
    Ukraine: 53
    Worldwide total number of subjects
    737
    EEA total number of subjects
    506
    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)
    43
    Adults (18-64 years)
    653
    From 65 to 84 years
    41
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants were randomized to a double-blind, placebo-controlled, parallel-group, 2-week treatment study to evaluate the safety and efficacy of fluticasone furoate nasal spray 110 micrograms (either once or twice daily) for the treatment of uncomplicated acute rhinosinusitis in adults and adolescent participants 12 years of age and older.

    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
    		 Investigator, Monitor, Carer, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    vehicle placebo

    Arm title
    		 FFNS 110 mcg QD
    Arm description
    		 Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fluticasone furoate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    110 micrograms once daily

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    vehicle placebo

    Arm title
    		 FFNS 110 mcg BD
    Arm description
    		 FFNS 110 mcg administered BD for 14 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fluticasone furoate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    110 micrograms twice daily

    Number of subjects in period 1
    		Placebo FFNS 110 mcg QD FFNS 110 mcg BD
    Started
    245
    240
    252
    Completed
    227
    232
    239
    Not completed
    18
    8
    13
         Consent withdrawn by subject
    2
    2
    4
         Physician decision
    1
    -
    1
         Adverse event, non-fatal
    10
    5
    5
         Lost to follow-up
    2
    -
    3
         Protocol deviation
    2
    1
    -
         Lack of efficacy
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days

    Reporting group title
    FFNS 110 mcg QD
    Reporting group description
    		 Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days

    Reporting group title
    FFNS 110 mcg BD
    Reporting group description
    		 FFNS 110 mcg administered BD for 14 days

    Reporting group values
    		 Placebo FFNS 110 mcg QD FFNS 110 mcg BD Total
    Number of subjects
    		 245 240 252 737
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 39.1 ( 14.81 ) 39.7 ( 15.64 ) 39 ( 16.02 ) -
    Gender categorical
    Units: Subjects
        Female
    		 143 148 169 460
        Male
    		 102 92 83 277
    Race, Customized
    Units: Subjects
        White
    		 238 234 244 716
        Black
    		 3 0 3 6
        Other (Other than White and Black)
    		 4 6 5 15

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days

    Reporting group title
    FFNS 110 mcg QD
    Reporting group description
    		 Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days

    Reporting group title
    FFNS 110 mcg BD
    Reporting group description
    		 FFNS 110 mcg administered BD for 14 days

    Primary: Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period (Weeks 1-2)

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    End point title
    		 Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period (Weeks 1-2)
    End point description
    The MSS was calculated as the sum of 3 individual symptom scores for nasal congestion/stuffiness, sinus headache/pressure or facial pain/pressure, and postnasal drip. Daily MSS was calculated as the average of the morning (AM) and evening (PM) MSS. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The total score ranged from 0 to 9. Change from baseline was calculated as the daily MSS averaged over the entire treatment period minus daily MSS over the baseline period (defined as the average daily MSS over the last 3 days prior to randomization). Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of ouble-blind study drug. Participants with missing diary data at baseline or post-baseline were not included in this analysis.
    End point type
    Primary
    End point timeframe
    Baseline and entire treatment period (up to 2 weeks)
    End point values
    		 Placebo FFNS 110 mcg QD FFNS 110 mcg BD
    Number of subjects analysed
    242 [1]
    237 [2]
    245 [3]
    Units: units on a scale
        least squares mean (standard error)
    -2.97 ( 0.12 )
    -3.36 ( 0.13 )
    -3.33 ( 0.13 )
    Notes
    [1] - ITT Population.
    [2] - ITT Population.
    [3] - ITT Population.
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    The estimation for least squares mean was adjusted for baseline value, country, allergic rhinitis status, age, and gender.
    Comparison groups
    Placebo v FFNS 110 mcg QD v FFNS 110 mcg BD
    Number of subjects included in analysis
    724
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.008
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    -0.386
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.67
         upper limit
    		 -0.1
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    The estimation for least squares mean was adjusted for baseline value, country, allergic rhinitis status, age, and gender.
    Comparison groups
    Placebo v FFNS 110 mcg BD v FFNS 110 mcg QD
    Number of subjects included in analysis
    724
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.014
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    -0.357
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.64
         upper limit
    		 -0.07

    Secondary: First Time to Symptom Improvement

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    End point title
    		 First Time to Symptom Improvement
    End point description
    Symptom improvement was defined as symptom scores less than or equal to 1 (i.e., mild or no symptoms) for all three major symptoms (nasal congestion/stuffiness, sinus headache/pressure or facial pain/pressure, and postnasal drip) on 2 consecutive 12-hour assessments. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. Participants with missing diary data at baseline or post-baseline were not included in this analysis.
    End point type
    Secondary
    End point timeframe
    Entire treatment period (up to 2 weeks)
    End point values
    		 Placebo FFNS 110 mcg QD FFNS 110 mcg BD
    Number of subjects analysed
    243 [4]
    239 [5]
    247 [6]
    Units: days
        median (full range (min-max))
    8 (1 to 14)
    7 (1 to 14)
    7 (1 to 14)
    Notes
    [4] - ITT Population.
    [5] - ITT Population.
    [6] - ITT Population.
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline Over the Entire Treatment Period in AM MSS

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    End point title
    		 Mean Change From Baseline Over the Entire Treatment Period in AM MSS
    End point description
    Mean change from baseline in MSS for nasal congestion/stuffiness, sinus headache/pressure or facial pain/pressure, and postnasal drip as measured in the morning (AM) was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The total score ranged from 0 to 9. Change from baseline in AM MSS was calculated as the AM MSS averaged over the entire treatment period minus the AM MSS over the baseline period (defined as the average AM MSS over the last 3 days prior to randomization). Participants with missing diary data at baseline or post-baseline were not included in this analysis.
    End point type
    Secondary
    End point timeframe
    Baseline and entire treatment period (up to 2 weeks)
    End point values
    		 Placebo FFNS 110 mcg QD FFNS 110 mcg BD
    Number of subjects analysed
    241 [7]
    235 [8]
    244 [9]
    Units: units on a scale
        arithmetic mean (standard deviation)
    -3.1 ( 0.12 )
    -3.4 ( 0.12 )
    -3.3 ( 0.11 )
    Notes
    [7] - ITT Population
    [8] - ITT Population
    [9] - ITT Population
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline Over the Entire Treatment Period in PM MSS

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    End point title
    		 Mean Change From Baseline Over the Entire Treatment Period in PM MSS
    End point description
    Mean change from baseline in MSS for nasal congestion/stuffiness, sinus headache/pressure or facial pain/pressure, and postnasal drip as measured in the evening (PM) was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The total score ranged from 0 to 9. Change from baseline in PM MSS was calculated as the PM MSS averaged over the entire treatment period minus the PM MSS over the baseline period (defined as the average PM MSS over the last 3 days prior to randomization). Participants with missing diary data at baseline or post-baseline were not included in this analysis.
    End point type
    Secondary
    End point timeframe
    Baseline and entire treatment period (up to 2 weeks)
    End point values
    		 Placebo FFNS 110 mcg QD FFNS 110 mcg BD
    Number of subjects analysed
    242 [10]
    236 [11]
    242 [12]
    Units: units on a scale
        arithmetic mean (standard error)
    -3 ( 0.12 )
    -3.4 ( 0.12 )
    -3.4 ( 0.12 )
    Notes
    [10] - ITT Population.
    [11] - ITT Population.
    [12] - ITT Population.
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline Over the Entire Treatment Period in the Daily Nasal Congestion/Stuffiness Score

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    End point title
    		 Mean Change From Baseline Over the Entire Treatment Period in the Daily Nasal Congestion/Stuffiness Score
    End point description
    Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the daily nasal congestion/stuffiness score was calculated as the daily score averaged over the entire treatment period minus the daily score over the baseline period (defined as the average daily score over the last 3 days prior to randomization). Participants with missing diary data at baseline or post-baseline were not included in this analysis.
    End point type
    Secondary
    End point timeframe
    Baseline and entire treatment period (up to 2 weeks)
    End point values
    		 Placebo FFNS 110 mcg QD FFNS 110 mcg BD
    Number of subjects analysed
    242 [13]
    237 [14]
    245 [15]
    Units: units on a scale
        arithmetic mean (standard error)
    -1 ( 0.04 )
    -1.1 ( 0.04 )
    -1.1 ( 0.04 )
    Notes
    [13] - ITT Population.
    [14] - ITT Population.
    [15] - ITT Population.
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline Over the Entire Treatment Period in the AM Nasal Congestion/Stuffiness Score

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    End point title
    		 Mean Change From Baseline Over the Entire Treatment Period in the AM Nasal Congestion/Stuffiness Score
    End point description
    Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the AM nasal congestion/stuffiness score was calculated as the AM score averaged over the entire treatment period minus the AM score over the baseline period (defined as the average AM score over the last 3 days prior to randomization). Participants with missing diary data at baseline or post-baseline were not included in this analysis.
    End point type
    Secondary
    End point timeframe
    Baseline and entire treatment period (up to 2 weeks)
    End point values
    		 Placebo FFNS 110 mcg QD FFNS 110 mcg BD
    Number of subjects analysed
    241 [16]
    235 [17]
    244 [18]
    Units: units on a scale
        arithmetic mean (standard error)
    -1 ( 0.04 )
    -1.1 ( 0.04 )
    -1.1 ( 0.04 )
    Notes
    [16] - ITT Population
    [17] - ITT Population
    [18] - ITT Population
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline Over the Entire Treatment Period in the PM Nasal Congestion/Stuffiness Score

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    End point title
    		 Mean Change From Baseline Over the Entire Treatment Period in the PM Nasal Congestion/Stuffiness Score
    End point description
    Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the PM nasal congestion/stuffiness score was calculated as the PM score averaged over the entire treatment period minus the PM score over the baseline period (defined as the average PM score over the last 3 days prior to randomization). Participants with missing diary data at baseline or post-baseline were not included in this analysis.
    End point type
    Secondary
    End point timeframe
    Baseline and entire treatment period (up to 2 weeks)
    End point values
    		 Placebo FFNS 110 mcg QD FFNS 110 mcg BD
    Number of subjects analysed
    242 [19]
    237 [20]
    242 [21]
    Units: units on a scale
        arithmetic mean (standard error)
    -1 ( 0.04 )
    -1.1 ( 0.05 )
    -1.1 ( 0.04 )
    Notes
    [19] - ITT Population.
    [20] - ITT Population.
    [21] - ITT Population.
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline Over the Entire Treatment Period in the Daily Sinus Headache/Pressure or Facial Pain/Pressure Score

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    End point title
    		 Mean Change From Baseline Over the Entire Treatment Period in the Daily Sinus Headache/Pressure or Facial Pain/Pressure Score
    End point description
    Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the daily sinus headache/pressure or facial pain/pressure score was calculated as the daily score averaged over the entire treatment period minus the daily score over the baseline period (defined as the average daily score over the last 3 days prior to randomization). Participants with missing diary data at baseline or post-baseline were not included in this analysis.
    End point type
    Secondary
    End point timeframe
    Baseline and entire treatment period (up to 2 weeks)
    End point values
    		 Placebo FFNS 110 mcg QD FFNS 110 mcg BD
    Number of subjects analysed
    242 [22]
    237 [23]
    245 [24]
    Units: units on a scale
        arithmetic mean (standard error)
    -1.1 ( 0.04 )
    -1.2 ( 0.05 )
    -1.2 ( 0.05 )
    Notes
    [22] - ITT Population.
    [23] - ITT Population.
    [24] - ITT Population.
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline Over the Entire Treatment Period in the AM Sinus Headache/Pressure or Facial Pain/Pressure Score

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    End point title
    		 Mean Change From Baseline Over the Entire Treatment Period in the AM Sinus Headache/Pressure or Facial Pain/Pressure Score
    End point description
    Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the AM sinus headache/pressure or facial pain/pressure score was calculated as the AM score averaged over the entire treatment period minus the AM score over the baseline period (defined as the average AM score over the last 3 days prior to randomization). Participants with missing diary data at baseline or post-baseline were not included in this analysis.
    End point type
    Secondary
    End point timeframe
    Baseline and entire treatment period (up to 2 weeks)
    End point values
    		 Placebo FFNS 110 mcg QD FFNS 110 mcg BD
    Number of subjects analysed
    241 [25]
    235 [26]
    244 [27]
    Units: units on a scale
        arithmetic mean (standard error)
    -1.2 ( 0.05 )
    -1.2 ( 0.05 )
    -1.2 ( 0.05 )
    Notes
    [25] - ITT Population.
    [26] - ITT Population.
    [27] - ITT Population.
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline Over the Entire Treatment Period in the PM Sinus Headache/Pressure or Facial Pain/Pressure Score

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    End point title
    		 Mean Change From Baseline Over the Entire Treatment Period in the PM Sinus Headache/Pressure or Facial Pain/Pressure Score
    End point description
    Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the PM sinus headache/pressure or facial pain/pressure score was calculated as the PM score averaged over the entire treatment period minus the PM score over the baseline period (defined as the average PM score over the last 3 days prior to randomization). Participants with missing diary data at baseline or post-baseline were not included in this analysis.
    End point type
    Secondary
    End point timeframe
    Baseline and entire treatment period (up to 2 weeks)
    End point values
    		 Placebo FFNS 110 mcg QD FFNS 110 mcg BD
    Number of subjects analysed
    242 [28]
    237 [29]
    242 [30]
    Units: units on a scale
        arithmetic mean (standard error)
    -1.1 ( 0.05 )
    -1.2 ( 0.05 )
    -1.2 ( 0.05 )
    Notes
    [28] - ITT Population
    [29] - ITT Population
    [30] - ITT Population
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline Over the Entire Treatment Period in the Daily Postnasal Drip Score

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    End point title
    		 Mean Change From Baseline Over the Entire Treatment Period in the Daily Postnasal Drip Score
    End point description
    Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the daily postnasal drip score was calculated as the daily postnasal drip score averaged over the entire treatment period minus the daily postnasal drip score over the baseline period (defined as the average daily postnasal drip score over the last 3 days prior to randomization). Participants with missing diary data at baseline or post-baseline were not included in this analysis.
    End point type
    Secondary
    End point timeframe
    Baseline and entire treatment period (up to 2 weeks)
    End point values
    		 Placebo FFNS 110 mcg QD FFNS 110 mcg BD
    Number of subjects analysed
    242 [31]
    237 [32]
    245 [33]
    Units: units on a scale
        arithmetic mean (standard error)
    -0.9 ( 0.05 )
    -1 ( 0.05 )
    -1 ( 0.04 )
    Notes
    [31] - ITT Population
    [32] - ITT Population
    [33] - ITT Population
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline Over the Entire Treatment Period in the AM Postnasal Drip Score

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    End point title
    		 Mean Change From Baseline Over the Entire Treatment Period in the AM Postnasal Drip Score
    End point description
    Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the AM postnasal drip score was calculated as the AM postnasal drip score averaged over the entire treatment period minus the AM postnasal drip score over the baseline period (defined as the average AM postnasal drip score over the last 3 days prior to randomization). Participants with missing diary data at baseline or post-baseline were not included in this analysis.
    End point type
    Secondary
    End point timeframe
    Baseline and entire treatment period (up to 2 weeks)
    End point values
    		 Placebo FFNS 110 mcg QD FFNS 110 mcg BD
    Number of subjects analysed
    241 [34]
    235 [35]
    244 [36]
    Units: units on a scale
        arithmetic mean (standard error)
    -0.9 ( 0.05 )
    -1.1 ( 0.05 )
    -1 ( 0.04 )
    Notes
    [34] - ITT Population
    [35] - ITT Population
    [36] - ITT Population
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline Over the Entire Treatment Period in the PM Postnasal Drip Score

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    End point title
    		 Mean Change From Baseline Over the Entire Treatment Period in the PM Postnasal Drip Score
    End point description
    Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the PM postnasal drip score was calculated as the PM postnasal drip score averaged over the entire treatment period minus the PM postnasal drip score over the baseline period (defined as the average PM postnasal drip score over the last 3 days prior to randomization). Participants with missing diary data at baseline or post-baseline were not included in this analysis.
    End point type
    Secondary
    End point timeframe
    Baseline and entire treatment period (up to 2 weeks)
    End point values
    		 Placebo FFNS 110 mcg QD FFNS 110 mcg BD
    Number of subjects analysed
    242 [37]
    236 [38]
    242 [39]
    Units: units on a scale
        arithmetic mean (standard error)
    -0.9 ( 0.05 )
    -1.1 ( 0.05 )
    -1 ( 0.05 )
    Notes
    [37] - ITT Population
    [38] - ITT Population
    [39] - ITT Population
    No statistical analyses for this end point

    Secondary: Number of Participants Who Require the Use of an Antibiotic Due to the Development of Fulminant Bacterial Rhinosinusitis (FBRS)

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    End point title
    		 Number of Participants Who Require the Use of an Antibiotic Due to the Development of Fulminant Bacterial Rhinosinusitis (FBRS)
    End point description
    Participants who required the use of an antibiotic due to the development of FBRS during the 2-week treatment period and the 2-week follow-up period were included in the analysis.
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    		 Placebo FFNS 110 mcg QD FFNS 110 mcg BD
    Number of subjects analysed
    245 [40]
    240 [41]
    252 [42]
    Units: participants
        number (not applicable)
    7
    7
    7
    Notes
    [40] - ITT Population
    [41] - ITT Population
    [42] - ITT Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from randomization until the follow up contact (Day 29).
    Adverse event reporting additional description
    The MedDRA version used for this study was not available.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days

    Reporting group title
    FFNS 110 mcg QD
    Reporting group description
    		 Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days

    Reporting group title
    FFNS 110 mcg BD
    Reporting group description
    		 FFNS 110 mcg administered BD for 14 days

    Serious adverse events
    		 Placebo FFNS 110 mcg QD FFNS 110 mcg BD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 240 (0.00%)
    1 / 252 (0.40%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Rib fracture
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 240 (0.00%)
    1 / 252 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Placebo FFNS 110 mcg QD FFNS 110 mcg BD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 245 (8.57%)
    23 / 240 (9.58%)
    23 / 252 (9.13%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    9 / 245 (3.67%)
    9 / 240 (3.75%)
    14 / 252 (5.56%)
         occurrences all number
    10
    9
    16
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    5 / 245 (2.04%)
    11 / 240 (4.58%)
    3 / 252 (1.19%)
         occurrences all number
    5
    12
    4
    Infections and infestations
    Sinusitis bacterial
         subjects affected / exposed
    8 / 245 (3.27%)
    7 / 240 (2.92%)
    7 / 252 (2.78%)
         occurrences all number
    8
    7
    7

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Feb 2010
    This is a country-specific amendment. The purpose of FFS113203 Amendment 01 is to remove the inclusion of adolescent subjects (12  ages < 18) for Czech Republic. Inclusion criterion 3., Age, on page 19 of the original protocol is amended accordingly.
    26 Feb 2010
    This is a country-specific amendment. The purpose of FFS113203 Amendment 02 is to clarify that anterior rhinoscopy using a speculum is used to assess nasal cavities during nasal examination.

    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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