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    Clinical Trial Results:
    A Pilot, Randomised, Double-blind, Placebo-controlled, Parallel-group, Multicentre Study to Evaluate the Efficacy and Safety of Once-daily Intranasal Administration of Fluticasone Furoate Nasal Spray 110 mcg for 4 Weeks in Adults and Adolescents with Irritant (Non-Allergic) Rhinitis

    Summary
    EudraCT number
    		 2015-004888-37
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    10 Feb 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Jan 2017
    First version publication date
    26 Jan 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    FFR111158
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    06 May 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Feb 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    TBD
    Protection of trial subjects
    Not Applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Mar 2008
    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
    Thailand: 102
    Worldwide total number of subjects
    102
    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)
    3
    Adults (18-64 years)
    99
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 147 participants were screened, of which 102 participants were randomized into the study.

    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, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Vehicle placebo nasal spray once daily
    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
    FFNS-matching placebo nasal spray, containing only the vehicle, was administered once daily for 4 weeks.

    Arm title
    		 FFNS 110 mcg
    Arm description
    		 Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fluticasone Furoate Nasal Spray (FFNS)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    FFNS was provided as a suspension containing 0.05% weight by weight of micronized fluticasone furoate. Each spray of the suspension delivered approximately 27.5 micrograms (mcg) of fluticasone furoate. Four sprays (two in each nostril), equivalent to 110 mcg, were administered in the morning, once daily for 4 weeks.

    Number of subjects in period 1
    		Placebo FFNS 110 mcg
    Started
    49
    53
    Completed
    45
    48
    Not completed
    4
    5
         Withdrew Consent
    -
    1
         Adverse event, non-fatal
    2
    -
         Protocol Deviation
    1
    2
         Lost to follow-up
    -
    1
         Lack of efficacy
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Vehicle placebo nasal spray once daily

    Reporting group title
    FFNS 110 mcg
    Reporting group description
    		 Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily

    Reporting group values
    		 Placebo FFNS 110 mcg Total
    Number of subjects
    		 49 53
    Age categorical
    Units: Subjects
    Age continuous
    Participants must have been 12 years of age or older.
    Units: years
        arithmetic mean (standard deviation)
    		 35.9 ( 10.89 ) 37.1 ( 12.78 ) -
    Gender categorical
    Gender categorical description
    Units: Subjects
        Female
    		 37 33 70
        Male
    		 12 20 32
    Race/Ethnicity, Customized
    Units: Subjects
        Asian
    		 49 53 102
    Other - Daily Reflective TNSS
    Total Symptom Scores (scale of 0-9; sum of the three individual nasal or ocular scores) based on 3 nasal symptoms (rhinorrhea, nasal congestion, and post-nasal drip) and 3 ocular symptoms (eye itching/burning, eye tearing/watering, and eye redness). Symptoms were evaluated on a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe).
    Units: points on a scale
        arithmetic mean (standard deviation)
    		 6.4 ( 1.16 ) 6.7 ( 1.25 ) -
    Other - Morning (AM) pre-dose instantaneous (i) TNSS
    Total Symptom Scores (scale of 0-9; sum of the three individual nasal or ocular scores) based on 3 nasal symptoms (rhinorrhea, nasal congestion, and post-nasal drip) and 3 ocular symptoms (eye itching/burning, eye tearing/watering, and eye redness). Symptoms were evaluated on a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe).
    Units: points on a scale
        arithmetic mean (standard deviation)
    		 6.3 ( 1.5 ) 6.5 ( 1.57 ) -
    Other - AM Reflective TNSS
    Total Symptom Scores (scale of 0-9; sum of the three individual nasal or ocular scores) based on 3 nasal symptoms (rhinorrhea, nasal congestion, and post-nasal drip) and 3 ocular symptoms (eye itching/burning, eye tearing/watering, and eye redness). Symptoms were evaluated on a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe).
    Units: points on a scale
        arithmetic mean (standard deviation)
    		 6.4 ( 1.24 ) 6.7 ( 1.36 ) -
    Other - Evening (PM) Reflective TNSS
    Total Symptom Scores (scale of 0-9; sum of the three individual nasal or ocular scores) based on 3 nasal symptoms (rhinorrhea, nasal congestion, and post-nasal drip) and 3 ocular symptoms (eye itching/burning, eye tearing/watering, and eye redness). Symptoms were evaluated on a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe).
    Units: points on a scale
        arithmetic mean (standard deviation)
    		 6.3 ( 1.31 ) 6.7 ( 1.32 ) -
    Other - Daily Reflective TOSS
    Total Symptom Scores (scale of 0-9; sum of the three individual nasal or ocular scores) based on 3 nasal symptoms (rhinorrhea, nasal congestion, and post-nasal drip) and 3 ocular symptoms (eye itching/burning, eye tearing/watering, and eye redness). Symptoms were evaluated on a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe).
    Units: points on a scale
        arithmetic mean (standard deviation)
    		 2.4 ( 2.17 ) 3.1 ( 2.27 ) -
    Other - AM pre-dose iTOSS
    Total Symptom Scores (scale of 0-9; sum of the three individual nasal or ocular scores) based on 3 nasal symptoms (rhinorrhea, nasal congestion, and post-nasal drip) and 3 ocular symptoms (eye itching/burning, eye tearing/watering, and eye redness). Symptoms were evaluated on a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe).
    Units: points on a scale
        arithmetic mean (standard deviation)
    		 2.4 ( 2.24 ) 3.1 ( 2.17 ) -
    Other - AM Reflective TOSS
    Total Symptom Scores (scale of 0-9; sum of the three individual nasal or ocular scores) based on 3 nasal symptoms (rhinorrhea, nasal congestion, and post-nasal drip) and 3 ocular symptoms (eye itching/burning, eye tearing/watering, and eye redness). Symptoms were evaluated on a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe).
    Units: points on a scale
        arithmetic mean (standard deviation)
    		 2.4 ( 2.2 ) 3 ( 2.16 ) -
    Other - PM Reflective TOSS
    Total Symptom Scores (scale of 0-9; sum of the three individual nasal or ocular scores) based on 3 nasal symptoms (rhinorrhea, nasal congestion, and post-nasal drip) and 3 ocular symptoms (eye itching/burning, eye tearing/watering, and eye redness). Symptoms were evaluated on a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe).
    Units: points on a scale
        arithmetic mean (standard deviation)
    		 2.4 ( 2.19 ) 3.2 ( 2.42 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Vehicle placebo nasal spray once daily

    Reporting group title
    FFNS 110 mcg
    Reporting group description
    		 Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily

    Primary: Mean change from baseline in daily rTNSS over the entire treatment period (28 days)

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    End point title
    		 Mean change from baseline in daily rTNSS over the entire treatment period (28 days)
    End point description
    The Total Nasal Symptom Score (TNSS) is the sum (scale 0-9) of the individual nasal scores for rhinorrhea, nasal congestion, and post-nasal drip. All symptoms were evaluated using a scale of 0 (None), 1 (Mild), 2 (Moderate), or 3 (Severe). Reflective (r) assessments were performed in the morning (AM) and evening (PM) and assessed the participant's symptoms over the preceding 12 hours. The daily reflective Total Nasal Symptoms Score (daily rTNSS) is the average of the AM and PM rTNSS. Mean change from baseline was calculated as the participant's treatment period mean minus the baseline mean. Intent-to-Treat (ITT) Population: all participants who received at least one dose of study medication
    End point type
    Primary
    End point timeframe
    Baseline through Week 4 (28 days)
    End point values
    		 Placebo FFNS 110 mcg
    Number of subjects analysed
    49 [1]
    53
    Units: points on a scale
        least squares mean (standard error)
    -2.1 ( 0.25 )
    -2.17 ( 0.23 )
    Notes
    [1] - ITT population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Center, baseline eosinophils, baseline symptom score, age, and gender were included as covariates in all efficacy analyses.
    Comparison groups
    FFNS 110 mcg v Placebo
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.845
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Mean change from baseline in AM rTNSS, PM rTNSS, and AM pre-dose iTNSS over the entire treatment period (28 days)

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    End point title
    		 Mean change from baseline in AM rTNSS, PM rTNSS, and AM pre-dose iTNSS over the entire treatment period (28 days)
    End point description
    The TNSS is the Total Nasal Symptom Score (scale 0-9), a sum of the individual nasal scores for (1) rhinorrhea, (2) nasal congestion, and (3) post-nasal drip. All 3 symptoms were evaluated using a scale of: 0 (None), 1 (Mild), 2 (Moderate), or 3 (Severe). Reflective (r) assessments were performed in the morning (AM) and evening (PM) and assessed the participant's symptoms over the preceding 12 hours (AM rTNSS, PM rTNSS). The AM pre-dose instantaneous assessment (AM pre-dose iTNSS) was performed in the morning just prior to dosing and assessed symptoms at that moment.
    End point type
    Secondary
    End point timeframe
    Baseline through Week 4 (28 days)
    End point values
    		 Placebo FFNS 110 mcg
    Number of subjects analysed
    49 [2]
    53
    Units: points on a scale
    least squares mean (standard error)
        AM pre-dose iTNSS
    -1.82 ( 0.26 )
    -1.9 ( 0.24 )
        AM rTNSS
    -2.13 ( 0.27 )
    -2.15 ( 0.24 )
        PM rTNSS
    -2.09 ( 0.25 )
    -2.19 ( 0.23 )
    Notes
    [2] - ITT population
    No statistical analyses for this end point

    Secondary: Mean change from baseline in daily reflective individual nasal symptoms score over the entire treatment period (28 days)

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    End point title
    		 Mean change from baseline in daily reflective individual nasal symptoms score over the entire treatment period (28 days)
    End point description
    Mean change for the individual symptoms of rhinorrhea, nasal congestion, and post-nasal drip. Reflective rating represents the participant's symptoms over the preceding 12 hours. Reflective assessments were performed in the morning (AM) and evening (PM). The daily reflective individual nasal symptom score average of the AM and PM reflective individual nasal symptoms is the daily reflective individual nasal symptom score. All symptoms were evaluated on a 0 (none) to 3 (severe) scale.
    End point type
    Secondary
    End point timeframe
    Baseline through Week 4 (28 days)
    End point values
    		 Placebo FFNS 110 mcg
    Number of subjects analysed
    49 [3]
    53
    Units: points on a scale
    least squares mean (standard error)
        Rhinorrhea
    -0.64 ( 0.09 )
    -0.72 ( 0.08 )
        Nasal congestion
    -0.75 ( 0.09 )
    -0.79 ( 0.08 )
        Post-nasal drip
    -0.7 ( 0.1 )
    -0.67 ( 0.09 )
    Notes
    [3] - ITT population
    No statistical analyses for this end point

    Secondary: Mean change from baseline in AM pre-dose instantaneous individual nasal symptoms over the entire treatment period (28 days)

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    End point title
    		 Mean change from baseline in AM pre-dose instantaneous individual nasal symptoms over the entire treatment period (28 days)
    End point description
    The AM pre-dose instantaneous assessment is performed in the morning prior to dosing and evaluates symptoms at that moment. The individual symptoms of rhinorrhea, nasal congestion, and post-nasal drip were measured at this time. All three symptoms were evaluated using a 0 (none) to 3 (severe) scale. This assessment provides information on the duration of action of the treatment.
    End point type
    Secondary
    End point timeframe
    Baseline through Week 4 (28 days)
    End point values
    		 Placebo FFNS 110 mcg
    Number of subjects analysed
    49 [4]
    53
    Units: points on a scale
    least squares mean (standard error)
        Rhinorrhea
    -0.52 ( 0.09 )
    -0.61 ( 0.09 )
        Nasal congestion
    -0.64 ( 0.09 )
    -0.71 ( 0.08 )
        Post-nasal drip
    -0.66 ( 0.1 )
    -0.58 ( 0.09 )
    Notes
    [4] - ITT population
    No statistical analyses for this end point

    Secondary: Mean change from baseline in AM and PM reflective individual nasal symptoms over the entire treatment period (28 days)

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    End point title
    		 Mean change from baseline in AM and PM reflective individual nasal symptoms over the entire treatment period (28 days)
    End point description
    Mean change for the individual symptoms of rhinorrhea, nasal congestion, and post-nasal drip as measured in the morning and evening. Reflective rating represents the participant's symptoms over the preceding 12 hours. All symptoms were evaluated on a 0 (none) to 3 (severe) scale.
    End point type
    Secondary
    End point timeframe
    Baseline through Week 4 (28 days)
    End point values
    		 Placebo FFNS 110 mcg
    Number of subjects analysed
    49 [5]
    53
    Units: points on a scale
    least squares mean (standard error)
        AM, rhinorrhea
    -0.65 ( 0.09 )
    -0.72 ( 0.08 )
        PM, rhinorrhea
    -0.63 ( 0.09 )
    -0.72 ( 0.09 )
        AM, nasal congestion
    -0.75 ( 0.09 )
    -0.78 ( 0.08 )
        PM, nasal congestion
    -0.76 ( 0.09 )
    -0.79 ( 0.09 )
        AM, post-nasal drip
    -0.73 ( 0.1 )
    -0.65 ( 0.09 )
        PM, post-nasal drip
    -0.69 ( 0.1 )
    -0.68 ( 0.09 )
    Notes
    [5] - ITT population
    No statistical analyses for this end point

    Secondary: Mean change from baseline in total ocular symptoms over the entire treatment period (28 days)

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    End point title
    		 Mean change from baseline in total ocular symptoms over the entire treatment period (28 days)
    End point description
    The Total Ocular Symptom Score (TOSS) is a sum (scale 0-9) of the individual ocular scores for eye itching/burning, eye tearing/watering, and eye redness. All 3 symptoms were evaluated using a scale of 0 (None), 1 (Mild), 2 (Moderate), or 2 (Severe). The daily reflective TOSS (daily rTOSS) is the average of the morning (AM) and evening (PM) rTOSS assessments that measure symptoms over the previous 12 hours. The AM pre-dose instantaneous (iTOSS) assessment is performed in the morning prior to dosing and evaluates symptoms at that moment, providing data on the duration of action of treatment.
    End point type
    Secondary
    End point timeframe
    Baseline through Week 4 (28 days)
    End point values
    		 Placebo FFNS 110 mcg
    Number of subjects analysed
    49 [6]
    53
    Units: points on a scale
    least squares mean (standard error)
        Daily rTOSS
    -0.77 ( 0.16 )
    -1.04 ( 0.14 )
        AM pre-dose iTOSS
    -0.85 ( 0.17 )
    -0.98 ( 0.15 )
        AM rTOSS
    -0.81 ( 0.17 )
    -0.96 ( 0.16 )
        PM rTOSS
    -0.74 ( 0.16 )
    -1.13 ( 0.15 )
    Notes
    [6] - ITT population
    No statistical analyses for this end point

    Secondary: Mean change from baseline in daily reflective individual ocular symptoms over the entire treatment period (28 days)

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    End point title
    		 Mean change from baseline in daily reflective individual ocular symptoms over the entire treatment period (28 days)
    End point description
    Mean change for the individual symptoms of eye itching/burning, eye tearing/watering, and eye redness. Reflective rating represents the participant's symptoms over the preceding 12 hours. Reflective assessments were performed twice daily (AM and PM). The average of the AM and PM reflective individual ocular symptoms is the daily reflective individual ocular symptoms. Reflective individual ocular symptoms were evaluated on a 0 (none) to 3 (severe) scale.
    End point type
    Secondary
    End point timeframe
    Baseline through Week 4 (28 days)
    End point values
    		 Placebo FFNS 110 mcg
    Number of subjects analysed
    49 [7]
    53
    Units: points on a scale
    least squares mean (standard error)
        Eye itching/burning
    -0.32 ( 0.07 )
    -0.45 ( 0.06 )
        Eye tearing/watering
    -0.29 ( 0.06 )
    -0.31 ( 0.06 )
        Eye redness
    -0.17 ( 0.06 )
    -0.28 ( 0.05 )
    Notes
    [7] - ITT population
    No statistical analyses for this end point

    Secondary: Mean change from baseline in AM pre-dose instantaneous individual ocular symptoms over the entire treatment period (28 days)

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    End point title
    		 Mean change from baseline in AM pre-dose instantaneous individual ocular symptoms over the entire treatment period (28 days)
    End point description
    The AM pre-dose instantaneous assessment is performed in the morning prior to dosing and evaluates symptoms at that moment. The individual symptoms of eye itching/burning, eye tearing/watering, and eye redness were measured at this time. All three symptoms were evaluated using a 0 (none) to 3 (severe) scale. This assessment provides information on the duration of action of the treatment.
    End point type
    Secondary
    End point timeframe
    Baseline through Week 4 (28 days)
    End point values
    		 Placebo FFNS 110 mcg
    Number of subjects analysed
    49 [8]
    53
    Units: points on a scale
    least squares mean (standard error)
        Eye itching/burning
    -0.35 ( 0.08 )
    -0.37 ( 0.07 )
        Eye tearing/watering
    -0.3 ( 0.06 )
    -0.33 ( 0.06 )
        Eye redness
    -0.21 ( 0.05 )
    -0.27 ( 0.05 )
    Notes
    [8] - ITT population
    No statistical analyses for this end point

    Secondary: Mean change from baseline in AM and PM reflective individual ocular symptoms over the entire treatment period (28 days)

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    End point title
    		 Mean change from baseline in AM and PM reflective individual ocular symptoms over the entire treatment period (28 days)
    End point description
    Mean change for the individual symptoms of eye itching/burning, eye tearing/watering, and eye redeness. Reflective ratings assessed the participant's symptoms over the preceding 12 hours. Reflective assessments were performed twice daily (AM and PM) and were evaluated on a 0 (none) to 3 (severe) scale.
    End point type
    Secondary
    End point timeframe
    Baseline through Week 4 (28 days)
    End point values
    		 Placebo FFNS 110 mcg
    Number of subjects analysed
    49 [9]
    53
    Units: points on a scale
    least squares mean (standard error)
        AM, eye itching/burning
    -0.34 ( 0.07 )
    -0.42 ( 0.06 )
        PM, eye itching/burning
    -0.3 ( 0.07 )
    -0.48 ( 0.06 )
        AM, eye tearing/watering
    -0.32 ( 0.07 )
    -0.29 ( 0.06 )
        PM, eye tearing/watering
    -0.27 ( 0.06 )
    -0.33 ( 0.05 )
        AM, eye redness
    -0.16 ( 0.06 )
    -0.23 ( 0.05 )
        PM, eye redness
    -0.19 ( 0.06 )
    -0.31 ( 0.05 )
    Notes
    [9] - ITT population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious adverse events (SAEs) and non-serious AEs were collected from Visit 2 (the start of study medication) to 5 days after the follow-up Visit 6 (approximately 34 days).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    FFNS 110 mcg
    Reporting group description
    		 Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily

    Reporting group title
    Placebo
    Reporting group description
    		 Vehicle placebo nasal spray once daily

    Serious adverse events
    		 FFNS 110 mcg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 49 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 FFNS 110 mcg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 53 (16.98%)
    3 / 49 (6.12%)
    Nervous system disorders
    Migraine
         subjects affected / exposed
    2 / 53 (3.77%)
    1 / 49 (2.04%)
         occurrences all number
    2
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 53 (5.66%)
    1 / 49 (2.04%)
         occurrences all number
    4
    3
    Nasal ulcer
         subjects affected / exposed
    2 / 53 (3.77%)
    1 / 49 (2.04%)
         occurrences all number
    3
    1
    Epistaxis
         subjects affected / exposed
    2 / 53 (3.77%)
    0 / 49 (0.00%)
         occurrences all number
    2
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Oct 2007
    The protocol amendment, made prior to beginning study enrolment, was to correct the wording regarding randomization stratification. Wording was changed to reflect that randomization would be stratified by baseline eosinophil levels collected by the nasal cytology assessment (positive level of >=5% versus negative levels of <5%). This change applied to all study centers.

    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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