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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo- Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy of Once-Daily Fluticasone Propionate Aqueous Nasal Spray 200mcg for 14 Days on Ocular Symptoms Associated with Seasonal Allergic Rhinitis

    Summary
    EudraCT number
    		 2015-001727-23
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    16 Feb 2013

    Results information
    Results version number
    		 v2(current)
    This version publication date
    09 Jun 2017
    First version publication date
    08 Aug 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Eudract is showing that results have issues. checking the errors
    Summary report(s)
    		 RH01619

    Trial information

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    Trial identification
    Sponsor protocol code
    RH01619
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01817790
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Consumer Healthcare
    Sponsor organisation address
    St. George's Avenue, Weybridge, United Kingdom, KT13 0DE
    Public contact
    Clinical trial disclosure desk, GlaxoSmithKline Consumer Healthcare, 866 435-7343,
    Scientific contact
    Clinical trial disclosure desk, GlaxoSmithKline Consumer Healthcare, 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
    15 May 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Feb 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Feb 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that a 14-day course of FP200QD is superior to placebo in relieving ocular symptoms associated with AR as determined by mean change from baseline in subject-rated reflective total ocular symptom scores (rTOSS)
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the World Medical Association Declaration of Helsinki. The study procedures did not pose any threat to the lives of the patients.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Apr 2012
    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: 626
    Worldwide total number of subjects
    626
    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)
    75
    Adults (18-64 years)
    522
    From 65 to 84 years
    29
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited at 6 clinical sites in the US.

    Pre-assignment
    Screening details
    		 Of the 855 participants screened, 626 were randomized in the study. Of the 229 participants not randomized into the study, 151 did not meet the study criteria; 3 developed AEs; 10 were lost to follow-up; 4 violated protocol; 28 withdrew consent; and the remaining 33 were not randomized for other reasons.

    Period 1
    Period 1 title
    Overall Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Fluticasone Propionate Nasal Spray
    Arm description
    		 Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fluticasone propionate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    50 mcg/spray (16 mL bottle – 120 metered sprays)

    Arm title
    		 Placebo Nasal Spray
    Arm description
    		 Two sprays of placebo per nostril to be administered in morning
    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
    50 mcg/spray (16 mL bottle – 120 metered sprays)

    Number of subjects in period 1
    		Fluticasone Propionate Nasal Spray Placebo Nasal Spray
    Started
    314
    312
    Completed
    310
    304
    Not completed
    4
    8
         Consent withdrawn by subject
    1
    3
         Adverse event, non-fatal
    -
    2
         Lost to follow-up
    -
    1
         Could not attend appointment
    1
    1
         Protocol deviation
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Fluticasone Propionate Nasal Spray
    Reporting group description
    		 Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).

    Reporting group title
    Placebo Nasal Spray
    Reporting group description
    		 Two sprays of placebo per nostril to be administered in morning

    Reporting group values
    		 Fluticasone Propionate Nasal Spray Placebo Nasal Spray Total
    Number of subjects
    		 314 312 626
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 40.4 ( 14.55 ) 40.5 ( 16.36 ) -
    Gender categorical
    Units: Subjects
        Female
    		 212 201 413
        Male
    		 102 111 213
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 1 0 1
        Asian
    		 1 2 3
        Black or African American
    		 36 38 74
        White
    		 272 270 542
        Native Hawaiian or other Pacific Islander
    		 1 1 2
        Multiple
    		 3 1 4

    End points

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    End points reporting groups
    Reporting group title
    Fluticasone Propionate Nasal Spray
    Reporting group description
    		 Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).

    Reporting group title
    Placebo Nasal Spray
    Reporting group description
    		 Two sprays of placebo per nostril to be administered in morning

    Primary: Mean Change From Baseline in Reflective Total Ocular Symptom Score (rTOSS)

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    End point title
    		 Mean Change From Baseline in Reflective Total Ocular Symptom Score (rTOSS)
    End point description
    The Reflective Total Ocular Symptom Score (rTOSS) is the sum of 3 individual participant-assessed symptom scores (eye itching/burning, eye tearing/watering, and eye redness), each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. Subjects completed rTOSS in the evening (PM rTOSS; 12 hours post morning nasal spray use) and once in the morning (AM score: prior to nasal spray use). Daily (i.e. during one dosing interval) rTOSS is defined as the average of the PM rTOSS and the AM rTOSS of the next day prior to AM dosing. The mean change from baseline in (daily, AM, PM) TOSS was calculated as the subject’s treatment period mean (over 14 days; from Day 0 PM to Day 14 AM) minus the baseline period (placebo run-in) mean.
    End point type
    Primary
    End point timeframe
    Baseline to 14 days
    End point values
    		 Fluticasone Propionate Nasal Spray Placebo Nasal Spray
    Number of subjects analysed
    314
    312
    Units: Score on Scale
        arithmetic mean (standard deviation)
    -0.91 ( 1.625 )
    -0.63 ( 1.525 )
    Statistical analysis title
    		 Reflective Total Ocular Symptom Score (rTOSS)
    Comparison groups
    Placebo Nasal Spray v Fluticasone Propionate Nasal Spray
    Number of subjects included in analysis
    626
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0024
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.59
         upper limit
    		 -0.13

    Secondary: Mean Change From Baseline in AM rTOSS

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    End point title
    		 Mean Change From Baseline in AM rTOSS
    End point description
    rTOSS is the sum of 3 individual participant-assessed symptom scores (eye itching/ burning, eye tearing/watering, and eye redness), each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For AM rToss, subject
    End point type
    Secondary
    End point timeframe
    Baseline to 14 days
    End point values
    		 Fluticasone Propionate Nasal Spray Placebo Nasal Spray
    Number of subjects analysed
    314
    312
    Units: Score on scale
        arithmetic mean (standard deviation)
    -0.96 ( 1.627 )
    -0.68 ( 1.573 )
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in PM rTOSS

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    End point title
    		 Mean Change From Baseline in PM rTOSS
    End point description
    rTOSS is the sum of 3 individual participant-assessed symptom scores (eye itching/ burning, eye tearing/watering, and eye redness), each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For PM rTOSS, subjects completed rTOSS in the evening, 12 hours post morning nasal spray use. The mean change from baseline in PM rTOSS was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.
    End point type
    Secondary
    End point timeframe
    Baseline to 14 days
    End point values
    		 Fluticasone Propionate Nasal Spray Placebo Nasal Spray
    Number of subjects analysed
    314
    312
    Units: Score on scale
        arithmetic mean (standard deviation)
    -0.87 ( 1.735 )
    -0.6 ( 1.577 )
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Itching/Burning

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    End point title
    		 Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Itching/Burning
    End point description
    The AM Reflective Ocular Symptom Score was assessed individually for eye itching/burning using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the morning, prior to nasal spray use. The mean change from baseline in AM Reflective Ocular Symptom Score (eye itching and burning) was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean
    End point type
    Secondary
    End point timeframe
    Baseline to 14 days
    End point values
    		 Fluticasone Propionate Nasal Spray Placebo Nasal Spray
    Number of subjects analysed
    314
    312
    Units: Score on scale
        arithmetic mean (standard deviation)
    -0.35 ( 0.581 )
    -0.28 ( 0.553 )
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Itching/Burning

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    End point title
    		 Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Itching/Burning
    End point description
    The PM Reflective Ocular Symptom Score was assessed individually for eye itching/burning using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the evening, 12 hours post morning nasal spray use. The mean change from baseline in PM Reflective Ocular Symptom Score (eye itching and burning) was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean
    End point type
    Secondary
    End point timeframe
    Baseline to 14 days
    End point values
    		 Fluticasone Propionate Nasal Spray Placebo Nasal Spray
    Number of subjects analysed
    314
    312
    Units: Score on scale
        arithmetic mean (standard deviation)
    -0.33 ( 0.626 )
    -0.24 ( 0.554 )
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Tearing/Watering

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    End point title
    		 Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Tearing/Watering
    End point description
    The AM Reflective Ocular Symptom Score was assessed individually for eye tearing/watering using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the morning, prior to nasal spray use. The mean change from baseline in AM Reflective Ocular Symptom Score (eye tearing/watering) was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.
    End point type
    Secondary
    End point timeframe
    Baseline to 14 days
    End point values
    		 Fluticasone Propionate Nasal Spray Placebo Nasal Spray
    Number of subjects analysed
    314
    312
    Units: Score on sclae
        arithmetic mean (standard deviation)
    -0.35 ( 0.596 )
    -0.24 ( 0.589 )
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Tearing/Watering

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    End point title
    		 Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Tearing/Watering
    End point description
    The PM Reflective Ocular Symptom Score was assessed individually for eye tearing/watering using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the evening, 12 hours post morning nasal spray use. The mean change from baseline in PM Reflective Ocular Symptom Score (eye tearing/watering) was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.
    End point type
    Secondary
    End point timeframe
    Baseline to 14 days
    End point values
    		 Fluticasone Propionate Nasal Spray Placebo Nasal Spray
    Number of subjects analysed
    314
    312
    Units: Score on scale
        arithmetic mean (standard deviation)
    -0.32 ( 0.653 )
    -0.19 ( 0.586 )
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Redness

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    End point title
    		 Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Redness
    End point description
    The AM Reflective Ocular Symptom Score was assessed individually for eye redness using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the morning, prior to nasal spray use. The mean change from baseline in AM Reflective Ocular Symptom Score (eye redness) was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean
    End point type
    Secondary
    End point timeframe
    Baseline to 14 days
    End point values
    		 Fluticasone Propionate Nasal Spray Placebo Nasal Spray
    Number of subjects analysed
    314
    312
    Units: Score on scale
        arithmetic mean (standard deviation)
    -0.26 ( 0.597 )
    -0.17 ( 0.613 )
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Redness

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    End point title
    		 Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Redness
    End point description
    The PM Reflective Ocular Symptom Score was assessed individually for eye redness using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the evening, 12 hours post morning nasal spray use. The mean change from baseline in PM Reflective Ocular Symptom Score (eye redness) was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.
    End point type
    Secondary
    End point timeframe
    Baseline to 14 days
    End point values
    		 Fluticasone Propionate Nasal Spray Placebo Nasal Spray
    Number of subjects analysed
    314
    312
    Units: Score on scale
        arithmetic mean (standard deviation)
    -0.22 ( 0.628 )
    -0.17 ( 0.635 )
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in AM Pre-dose Instantaneous Total Ocular Symptom Scores (iTOSS)

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    End point title
    		 Mean Change From Baseline in AM Pre-dose Instantaneous Total Ocular Symptom Scores (iTOSS)
    End point description
    Instantaneous total ocular symptom scores (iTOSS) assessments are self perceived evaluation of symptom severity immediately before the dose (how the subject feels at that point in time). iTOSS (possible score of 0-9) is the sum of 3 individual participant-assessed symptom scores for eye itching/burning, eye tearing/watering, and eye redness each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. Mean changes from baseline were calculated as treatment period iTOSS minus baseline iTOSS.
    End point type
    Secondary
    End point timeframe
    Baseline to 14 days
    End point values
    		 Fluticasone Propionate Nasal Spray Placebo Nasal Spray
    Number of subjects analysed
    314
    312
    Units: Score on a scale
        arithmetic mean (standard deviation)
    -0.8 ( 1.443 )
    -0.55 ( 1.531 )
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Reflective Nasal Congestion Symptom Score (rNCSS)

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    End point title
    		 Mean Change From Baseline in Reflective Nasal Congestion Symptom Score (rNCSS)
    End point description
    The rNCSS is a participant perceived evaluation of overall congestion symptom severity (evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe) which was completed once in the evening (PM), and once in the morning (AM). rNCSS is defined as the average of the PM rNCSS and the AM rNCSS of the next day prior to AM dosing. The mean change from baseline in rNCSS (daily, AM, PM)was calculated as the subject's treatment period mean (over 14 days; from Day 0 PM to Day 14 AM) minus the baseline period (placebo run-in) mean.
    End point type
    Secondary
    End point timeframe
    Baseline to 14 days
    End point values
    		 Fluticasone Propionate Nasal Spray Placebo Nasal Spray
    Number of subjects analysed
    314
    312
    Units: Score on scale
        arithmetic mean (standard deviation)
    -0.34 ( 0.547 )
    -0.2 ( 0.443 )
    No statistical analyses for this end point

    Secondary: End-of-treatment Assessment of Response to Therapy for Ocular Symptoms

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    End point title
    		 End-of-treatment Assessment of Response to Therapy for Ocular Symptoms
    End point description
    Overall response to therapy assessment was done using a 7-point categorical scale in which participants rated their response to therapy as follows: +3 = Significantly Improved; +2 = Moderately Improved; +1 = Mildly Improved; 0 = No Change; -1= Mildly Worse; -2 = Moderately Worse; -3 = Significantly Worse.
    End point type
    Secondary
    End point timeframe
    Baseline to 14 days
    End point values
    		 Fluticasone Propionate Nasal Spray Placebo Nasal Spray
    Number of subjects analysed
    313
    309
    Units: Participants
    number (not applicable)
        Significantly improved
    22
    16
        Moderately improved
    76
    59
        Mildly improved
    79
    71
        No change
    81
    97
        Mildly Worse
    21
    20
        Moderately Worse
    24
    24
        Significantly Worse
    10
    22
    No statistical analyses for this end point

    Secondary: Mean Change in Objective Assessment of Conjunctival Redness

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    End point title
    		 Mean Change in Objective Assessment of Conjunctival Redness
    End point description
    Conjunctival redness was evaluated as a clinical sign of SAR by the investigator. Scoring of severity was rated according to a 4-point scale: 0 = normal; 1 = Slightly pink; 2 = Moderately pink, some dilation; 3 = Intense red vessels, dilated.
    End point type
    Secondary
    End point timeframe
    Baseline to 14 days
    End point values
    		 Fluticasone Propionate Nasal Spray Placebo Nasal Spray
    Number of subjects analysed
    314
    312
    Units: Score on scale
        arithmetic mean (standard deviation)
    -0.2 ( 0.815 )
    -0.15 ( 0.736 )
    No statistical analyses for this end point

    Secondary: Mean Changes From Baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Scores

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    End point title
    		 Mean Changes From Baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Scores
    End point description
    MiniRQLQ is a 14-item, disease-specific instrument for assessing the impact of allergic rhinitis on activities of daily living and overall well-being. It measures five domains of functional impairment that are most important to subjects with SAR: practical problems, nasal symptoms, eye symptoms, activity limitations, and other symptoms. Participants scored their degree of impairment on a seven-point scale. (0 - 6). Mini RQLQ final score is the average of sub-scales, ranges from 0 (best possible outcome) to 6 (worst possible outcome).
    End point type
    Secondary
    End point timeframe
    Baseline to 14 days
    End point values
    		 Fluticasone Propionate Nasal Spray Placebo Nasal Spray
    Number of subjects analysed
    314
    311
    Units: Score on scale
        arithmetic mean (standard deviation)
    -0.98 ( 1.311 )
    -0.49 ( 1.091 )
    No statistical analyses for this end point

    Secondary: Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Activities

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    End point title
    		 Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Activities
    End point description
    MiniRQLQ is a 14-item, disease-specific instrument for assessing the impact of allergic rhinitis on activities of daily living and overall well-being. Activity limitations is one of the domains of Mini RQLQ scores. Participants scored their degree of impairment on a seven-point scale (0 = not troubled, 6 = extremely troubled).
    End point type
    Secondary
    End point timeframe
    Baseline to 14 days
    End point values
    		 Fluticasone Propionate Nasal Spray Placebo Nasal Spray
    Number of subjects analysed
    314
    311
    Units: Score on scale
        arithmetic mean (standard deviation)
    -0.93 ( 1.384 )
    -0.39 ( 1.269 )
    No statistical analyses for this end point

    Secondary: Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Practical Problems

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    End point title
    		 Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Practical Problems
    End point description
    MiniRQLQ is a 14-item, disease-specific instrument for assessing the impact of allergic rhinitis on activities of daily living and overall well-being. Activity limitations is one of the domains of Mini RQLQ scores. Participants scored their degree of impairment on a seven-point scale (0 = not troubled, 6 = extremely troubled).
    End point type
    Secondary
    End point timeframe
    Baseline to 14 days
    End point values
    		 Fluticasone Propionate Nasal Spray Placebo Nasal Spray
    Number of subjects analysed
    314
    311
    Units: Score on a scale
        arithmetic mean (standard deviation)
    -1.04 ( 1.476 )
    -0.57 ( 1.258 )
    No statistical analyses for this end point

    Secondary: Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Nose Symptoms

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    End point title
    		 Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Nose Symptoms
    End point description
    MiniRQLQ is a 14-item, disease-specific instrument for assessing the impact of allergic rhinitis on activities of daily living and overall well-being. "Nose Symptoms" is one of the domains of Mini RQLQ scores. Participants scored their degree of impairment on a seven-point scale (0 = not troubled, 6 = extremely troubled).
    End point type
    Secondary
    End point timeframe
    Baseline to 14 days
    End point values
    		 Fluticasone Propionate Nasal Spray Placebo Nasal Spray
    Number of subjects analysed
    313
    310
    Units: Score on scale
        arithmetic mean (standard deviation)
    -1.09 ( 1.456 )
    -0.5 ( 1.257 )
    No statistical analyses for this end point

    Secondary: Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Eye Symptoms

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    End point title
    		 Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Eye Symptoms
    End point description
    MiniRQLQ is a 14-item, disease-specific instrument for assessing the impact of allergic rhinitis on activities of daily living and overall well-being. "Eye Symptoms" is one of the domains of Mini RQLQ scores. Participants scored their degree of impairment on a seven-point scale (0 = not troubled, 6 = extremely troubled).
    End point type
    Secondary
    End point timeframe
    Baseline to 14 days
    End point values
    		 Fluticasone Propionate Nasal Spray Placebo Nasal Spray
    Number of subjects analysed
    313
    310
    Units: Score on a scale
        arithmetic mean (standard deviation)
    -0.98 ( 1.512 )
    -0.55 ( 1.284 )
    No statistical analyses for this end point

    Secondary: Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Other Symptoms

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    End point title
    		 Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Other Symptoms
    End point description
    MiniRQLQ is a 14-item, disease-specific instrument for assessing the impact of allergic rhinitis on activities of daily living and overall well-being. "Other Symptoms" is one of the domains of Mini RQLQ scores. Participants scored their degree of impairment on a seven-point scale (0 = not troubled, 6 = extremely troubled).
    End point type
    Secondary
    End point timeframe
    Baseline to 14 days
    End point values
    		 Fluticasone Propionate Nasal Spray Placebo Nasal Spray
    Number of subjects analysed
    313
    310
    Units: Score on a scale
        arithmetic mean (standard deviation)
    -0.89 ( 1.607 )
    -0.48 ( 1.294 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Participants were followed for the duration of study, an average of 3 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    Fluticasone Propionate Nasal Spray
    Reporting group description
    		 Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).

    Reporting group title
    Placebo Nasal Spray
    Reporting group description
    		 Two sprays of placebo per nostril to be administered in morning.

    Serious adverse events
    		 Fluticasone Propionate Nasal Spray Placebo Nasal Spray
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 312 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0.3%
    Non-serious adverse events
    		 Fluticasone Propionate Nasal Spray Placebo Nasal Spray
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 314 (2.55%)
    8 / 312 (2.56%)
    Injury, poisoning and procedural complications
    Laceration
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 312 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 312 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 312 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 314 (0.64%)
    0 / 312 (0.00%)
         occurrences all number
    2
    0
    Migraine
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences all number
    0
    1
    Pyrexia
         subjects affected / exposed
    1 / 314 (0.32%)
    2 / 312 (0.64%)
         occurrences all number
    1
    2
    Thrist
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 312 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences all number
    0
    1
    Respiratory Tract Congestion
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences all number
    0
    1
    Throat irritation
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 312 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences all number
    0
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 314 (0.00%)
    2 / 312 (0.64%)
         occurrences all number
    0
    2
    Gastrointestinal Viral
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 312 (0.00%)
         occurrences all number
    1
    0
    Influenza
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 312 (0.32%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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