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    Clinical Trial Results:
    A Phase III, Double-Blind, Randomized, Placebo-Controlled Cross-Over Clinical Trial to Study the Efficacy and Safety of MK-0476 in Japanese Pediatric Subjects with Seasonal Allergic Rhinitis

    Summary
    EudraCT number
    		 2014-004774-42
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    01 Sep 2013

    Results information
    Results version number
    		 v2(current)
    This version publication date
    10 Mar 2016
    First version publication date
    09 Jul 2015
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    0476-519
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01857063
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 MK-0476-519: Merck protocol number
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    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
    01 Sep 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Sep 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Sep 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study will evaluate the efficacy and safety of montelukast (MK-0476) in the treatment of Japanese pediatric participants with seasonal allergic rhinitis (SAR). The primary hypothesis of this study is that montelukast is superior to placebo in the treatment of nasal symptoms in SAR.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Jun 2013
    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
    Japan: 220
    Worldwide total number of subjects
    220
    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)
    68
    Adolescents (12-17 years)
    152
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Japanese participants aged 10 to 15 years who had allergic rhinitis symptoms (Japanese Cedar [JC] pollinosis) were screened for this study.

    Period 1
    Period 1 title
    Treatment Period 1 (7 days)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Montelukast/Placebo
    Arm description
    		 Participants receive montelukast 5 mg chewable tablets for 7 days during Treatment Period 1 and receive placebo chewable tablets for 7 days during Treatment Period 2. There is a 7-day washout period between Treatment Periods 1 and 2.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Montelukast
    Investigational medicinal product code
    Other name
    MK-0476
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Montelukast 5 mg chewable tablets orally once daily for 7 days

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo chewable tablets orally once daily for 7 days

    Arm title
    		 Placebo/Montelukast
    Arm description
    		 Participants receive placebo chewable tablets for 7 days during Treatment Period 1 and receive montelukast 5 mg chewable tablets for 7 days during Treatment Period 2. There is a 7-day washout period between Treatment Periods 1 and 2.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo chewable tablets orally once daily for 7 days

    Investigational medicinal product name
    Montelukast
    Investigational medicinal product code
    Other name
    MK-0476
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Montelukast 5 mg chewable tablets orally once daily for 7 days

    Number of subjects in period 1
    		Montelukast/Placebo Placebo/Montelukast
    Started
    110
    110
    Completed
    108
    106
    Not completed
    2
    4
         Consent withdrawn by subject
    1
    3
         Physician decision
    1
    -
         Adverse event, non-fatal
    -
    1
    Period 2
    Period 2 title
    Treatment Period 2 (7 days)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo/Montelukast
    Arm description
    		 Participants receive placebo chewable tablets for 7 days during Treatment Period 1 and receive montelukast 5 mg chewable tablets for 7 days during Treatment Period 2. There is a 7-day washout period between Treatment Periods 1 and 2.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo chewable tablets orally once daily for 7 days

    Investigational medicinal product name
    Montelukast
    Investigational medicinal product code
    Other name
    MK-0476
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Montelukast 5 mg chewable tablets orally once daily for 7 days

    Arm title
    		 Montelukast/Placebo
    Arm description
    		 Participants receive montelukast 5 mg chewable tablets for 7 days during Treatment Period 1 and receive placebo chewable tablets for 7 days during Treatment Period 2. There is a 7-day washout period between Treatment Periods 1 and 2.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo chewable tablets orally once daily for 7 days

    Investigational medicinal product name
    Montelukast
    Investigational medicinal product code
    Other name
    MK-0476
    Pharmaceutical forms
    Chewable tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Montelukast 5 mg chewable tablets orally once daily for 7 days

    Number of subjects in period 2
    		Placebo/Montelukast Montelukast/Placebo
    Started
    106
    108
    Completed
    104
    104
    Not completed
    2
    4
         Physician decision
    1
    1
         Consent withdrawn by subject
    -
    1
         Adverse event, non-fatal
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Montelukast/Placebo
    Reporting group description
    		 Participants receive montelukast 5 mg chewable tablets for 7 days during Treatment Period 1 and receive placebo chewable tablets for 7 days during Treatment Period 2. There is a 7-day washout period between Treatment Periods 1 and 2.

    Reporting group title
    Placebo/Montelukast
    Reporting group description
    		 Participants receive placebo chewable tablets for 7 days during Treatment Period 1 and receive montelukast 5 mg chewable tablets for 7 days during Treatment Period 2. There is a 7-day washout period between Treatment Periods 1 and 2.

    Reporting group values
    		 Montelukast/Placebo Placebo/Montelukast Total
    Number of subjects
    		 110 110 220
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 31 37 68
        Adolescents (12-17 years)
    		 79 73 152
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 12.6 ( 1.5 ) 12.4 ( 1.6 ) -
    Gender, Male/Female
    Units: participants
        Female
    		 55 59 114
        Male
    		 55 51 106

    End points

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    End points reporting groups
    Reporting group title
    Montelukast/Placebo
    Reporting group description
    		 Participants receive montelukast 5 mg chewable tablets for 7 days during Treatment Period 1 and receive placebo chewable tablets for 7 days during Treatment Period 2. There is a 7-day washout period between Treatment Periods 1 and 2.

    Reporting group title
    Placebo/Montelukast
    Reporting group description
    		 Participants receive placebo chewable tablets for 7 days during Treatment Period 1 and receive montelukast 5 mg chewable tablets for 7 days during Treatment Period 2. There is a 7-day washout period between Treatment Periods 1 and 2.
    Reporting group title
    Placebo/Montelukast
    Reporting group description
    		 Participants receive placebo chewable tablets for 7 days during Treatment Period 1 and receive montelukast 5 mg chewable tablets for 7 days during Treatment Period 2. There is a 7-day washout period between Treatment Periods 1 and 2.

    Reporting group title
    Montelukast/Placebo
    Reporting group description
    		 Participants receive montelukast 5 mg chewable tablets for 7 days during Treatment Period 1 and receive placebo chewable tablets for 7 days during Treatment Period 2. There is a 7-day washout period between Treatment Periods 1 and 2.

    Subject analysis set title
    Montelukast - Efficacy
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants receive montelukast 5 mg for 7 days, regardless of sequence. Efficacy analysis set includes all randomized participants who took at least one dose of study drug (montelukast), and had a baseline assessment and at least one post-baseline assessment in a treatment period.

    Subject analysis set title
    Montelukast - Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants receive montelukast 5 mg for 7 days, regardless of sequence. Safety analysis set includes all randomized participants who received at least one dose of study drug (montelukast). Adverse events (AEs) are reported by study drug (montelukast) taken at time of the event.

    Subject analysis set title
    Placebo - Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants receive placebo for 7 days, regardless of sequence. Safety analysis set includes all randomized participants who received at least one dose of study drug (placebo for montelukast). Adverse events (AEs) are reported by study drug (placebo for montelukast) taken at time of the event.

    Subject analysis set title
    Placebo - Efficacy
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants receive placebo for 7 days, regardless of sequence. Efficacy analysis set includes all randomized participants who took at least one dose of study drug (placebo for montelukast), and had a baseline assessment and at least one post-baseline assessment in a treatment period.

    Primary: Change from Baseline in Total Nasal Symptom Score (TNSS) Averaged During 3 Hours of Exposure

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    End point title
    		 Change from Baseline in Total Nasal Symptom Score (TNSS) Averaged During 3 Hours of Exposure
    End point description
    The TNSS is the sum of the three nasal symptom scores for nasal congestion, nasal discharge and sneezing. Participants completed a questionnaire about their nasal symptoms. Scores ranged from 0 to 4 for each of the three nasal symptoms, with a total possible score ranging from 0 to 12 and a higher score indicating more severe nasal symptoms. The Baseline TNSS was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-Baseline TNSS was assessed on Day 7 of a treatment period during 3 hours of exposure to JC pollen in the chamber room, as an average of measurements at 30, 60, 90, 120, 150 and 180 minutes. Analysis was done by study drug as taken.
    End point type
    Primary
    End point timeframe
    Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period
    End point values
    		 Montelukast - Efficacy Placebo - Efficacy
    Number of subjects analysed
    213
    211
    Units: score on a scale
        least squares mean (confidence interval 95%)
    1.17 (1.03 to 1.31)
    1.18 (1.04 to 1.32)
    Statistical analysis title
    		 Difference in least squares (LS) means
    Statistical analysis description
    Difference in LS means of change from Baseline in TNSS averaged during 3 hours of exposure - Montelukast vs. Placebo. Based on longitudinal data analysis (LDA) model with Baseline TNSS as a covariate, sequence, treatment and period as fixed effects and participants as a random effect.
    Comparison groups
    Montelukast - Efficacy v Placebo - Efficacy
    Number of subjects included in analysis
    424
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.913 [1]
    Method
    		 Longitudinal Data Analysis (LDA)
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.11
         upper limit
    		 0.1
    Notes
    [1] - LDA model with baseline TNSS as a covariate, sequence, treatment and period as fixed effects and participant as a random effect.

    Primary: Percentage of Participants Who Experience at Least One Adverse Event

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    End point title
    		 Percentage of Participants Who Experience at Least One Adverse Event [2]
    End point description
    An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for occurrence of adverse events for up to 14 days after last dose of study drug. Analysis was done by study drug as taken.
    End point type
    Primary
    End point timeframe
    Up to 5 weeks
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this end point.
    End point values
    		 Montelukast - Safety Placebo - Safety
    Number of subjects analysed
    216
    218
    Units: percentage of participants
        number (not applicable)
    22
    36
    No statistical analyses for this end point

    Secondary: Change from Baseline in Weighted TNSS Averaged During 3 Hours of Exposure

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    End point title
    		 Change from Baseline in Weighted TNSS Averaged During 3 Hours of Exposure
    End point description
    TNSS was weighted as 2:1:1 for nasal congestion, nasal discharge and sneezing, respectively. The Weighted TNSS ranged from 0 to 16, with a higher score indicating more severe weighted total nasal symptoms. The Baseline Weighted TNSS was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-Baseline TNSS was assessed on Day 7 of a treatment period during 3 hours of exposure to JC pollen in the chamber room, as an average of measurements at 30, 60, 90, 120, 150 and 180 minutes. Analysis was done by study drug as taken.
    End point type
    Secondary
    End point timeframe
    Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period
    End point values
    		 Montelukast - Efficacy Placebo - Efficacy
    Number of subjects analysed
    213
    211
    Units: score on a scale
        least squares mean (confidence interval 95%)
    1.85 (1.63 to 2.07)
    1.86 (1.63 to 2.08)
    Statistical analysis title
    		 Difference in LS means
    Statistical analysis description
    Difference in LS means for change from Baseline in weighted TNSS averaged during 3 hours of exposure - Montelukast vs. Placebo. Based on LDA model with Baseline weighted TNSS as a covariate, sequence, treatment and period as fixed effects and participants as a random effect.
    Comparison groups
    Montelukast - Efficacy v Placebo - Efficacy
    Number of subjects included in analysis
    424
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.953 [3]
    Method
    		 LDA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.17
         upper limit
    		 0.16
    Notes
    [3] - LDA model with baseline Weighted TNSS as a covariate, sequence, treatment and period as fixed effects and participant as a random effect.

    Secondary: Change from Baseline in Nasal Congestion Score Averaged During 3 Hours of Exposure

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    End point title
    		 Change from Baseline in Nasal Congestion Score Averaged During 3 Hours of Exposure
    End point description
    The Nasal Congestion Score was assessed as 0 = No symptoms of nasal congestion to 4 = Completely obstructed all day, with a possible Nasal Congestion Score ranging from 0 to 4 and a higher score indicating more severe nasal congestion. The Baseline Nasal Congestion Score was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-Baseline Nasal Congestion Score was assessed on Day 7 of a treatment period during 3 hours of exposure to JC pollen in the chamber room, as an average of measurements at 30, 60, 90, 120, 150 and 180 minutes. Analysis was done by study drug as taken.
    End point type
    Secondary
    End point timeframe
    Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period
    End point values
    		 Montelukast - Efficacy Placebo - Efficacy
    Number of subjects analysed
    213
    211
    Units: score on a scale
        least squares mean (confidence interval 95%)
    0.68 (0.59 to 0.76)
    0.68 (0.59 to 0.76)
    Statistical analysis title
    		 Difference in LS means
    Statistical analysis description
    Difference in LS means of change from Baseline in Nasal Congestion Score averaged during 3 hours of exposures - Montelukast vs. Placebo. Based on LDA model with Baseline Nasal Congestion Score as a coavariate, sequence, treatment and period as fixed effects and participants as a random effect.
    Comparison groups
    Montelukast - Efficacy v Placebo - Efficacy
    Number of subjects included in analysis
    424
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.974 [4]
    Method
    		 LDA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.07
         upper limit
    		 0.07
    Notes
    [4] - LDA model with baseline nasal congestion score as a covariate, sequence, treatment and period as fixed effects and participant as a random effect.

    Secondary: Change from Baseline in Nasal Discharge Score Averaged During 3 Hours of Exposure

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    End point title
    		 Change from Baseline in Nasal Discharge Score Averaged During 3 Hours of Exposure
    End point description
    The Nasal Discharge Score was assessed as 0 = 0 times participant blew his/her nose to 4 = 21 or more times participant blew his/her nose, with a possible Nasal Discharge Score ranging from 0 to 4 and a higher score indicating more severe nasal discharge. The Baseline Nasal Discharge Score was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-Baseline Nasal Discharge Score was assessed on Day 7 of a treatment period during 3 hours of exposure to JC pollen in the chamber room, as an average of measurements at 30, 60, 90, 120, 150 and 180 minutes. Analysis was done by study drug as taken.
    End point type
    Secondary
    End point timeframe
    Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period
    End point values
    		 Montelukast - Efficacy Placebo - Efficacy
    Number of subjects analysed
    213
    211
    Units: score on a scale
        least squares mean (confidence interval 95%)
    0.29 (0.25 to 0.34)
    0.32 (0.27 to 0.37)
    Statistical analysis title
    		 Difference in LS means
    Statistical analysis description
    Difference in LS means for change from Baseline in Nasal Discharge Score averaged during 3 hours of exposure - Montelukast vs. Placebo. Based on LDA model with Baseline Nasal Discharge Score as a covariate, sequence, treatment and period as fixed effects and participant as a random effect.
    Comparison groups
    Montelukast - Efficacy v Placebo - Efficacy
    Number of subjects included in analysis
    424
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.182 [5]
    Method
    		 LDA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.06
         upper limit
    		 0.01
    Notes
    [5] - LDA model with baseline nasal discharge score as a covariate, sequence, treatment and period as fixed effects and participant as a random effect.

    Secondary: Change from Baseline in Sneezing Score Averaged During 3 Hours of Exposure

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    End point title
    		 Change from Baseline in Sneezing Score Averaged During 3 Hours of Exposure
    End point description
    The Sneezing Score was assessed as 0 = 0 times participant sneezed to 4 = 21 or more times participant sneezed, with a possible Sneezing Score ranging from 0 to 4 and a higher score indicating more severe sneezing. The Baseline Sneezing Score was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-Baseline Sneezing Score was assessed on Day 7 of a treatment period during 3 hours of exposure to JC pollen in the chamber room, as an average of measurements at 30, 60, 90, 120, 150 and 180 minutes. Analysis was done by study drug as taken.
    End point type
    Secondary
    End point timeframe
    Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period
    End point values
    		 Montelukast - Efficacy Placebo - Efficacy
    Number of subjects analysed
    213
    211
    Units: score on a scale
        least squares mean (confidence interval 95%)
    0.2 (0.16 to 0.24)
    0.18 (0.14 to 0.22)
    Statistical analysis title
    		 Difference in LS means
    Statistical analysis description
    Difference in LS means for change from Baseline in Sneezing Score averaged during 3 hours of exposure - Montelukast vs. Placebo. Based on LDA model with Baseline Sneezing Score as a covariate, sequence, treatment and period as fixed effects and participant as a random effect.
    Comparison groups
    Montelukast - Efficacy v Placebo - Efficacy
    Number of subjects included in analysis
    424
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.161 [6]
    Method
    		 LDA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.01
         upper limit
    		 0.05
    Notes
    [6] - LDA model with baseline sneezing score as a covariate, sequence, treatment and period as fixed effects and participant as a random effect.

    Secondary: Change from Baseline in TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room

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    End point title
    		 Change from Baseline in TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room
    End point description
    The TNSS is the sum of the three nasal symptom scores for nasal congestion, nasal discharge and sneezing. The possible TNSS ranged from 0 to 12, with a higher score indicting more severe total nasal symptoms. The Baseline TNSS was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-Baseline TNSS was assessed on Day 7 of a treatment period at 30, 60, 90, 120, 150 and 180 minutes after entering the chamber room. Analysis was done by study drug as taken.
    End point type
    Secondary
    End point timeframe
    Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period
    End point values
    		 Montelukast - Efficacy Placebo - Efficacy
    Number of subjects analysed
    213
    211
    Units: score on a scale
    least squares mean (confidence interval 95%)
        30 minutes after entering chamber room
    0.54 (0.42 to 0.67)
    0.59 (0.46 to 0.71)
        60 minutes after entering chamber room
    1 (0.84 to 1.16)
    1.07 (0.91 to 1.23)
        90 minutes after entering chamber room
    1.36 (1.18 to 1.55)
    1.31 (1.12 to 1.49)
        120 minutes after entering chamber room
    1.38 (1.18 to 1.57)
    1.35 (1.16 to 1.54)
        150 minutes after entering chamber room
    1.38 (1.19 to 1.57)
    1.35 (1.16 to 1.54)
        180 minutes after entering chamber room
    1.39 (1.19 to 1.59)
    1.4 (1.21 to 1.6)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Weighted TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room

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    End point title
    		 Change from Baseline in Weighted TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room
    End point description
    TNSS was weighted as 2:1:1 for nasal congestion, nasal discharge and sneezing. The possible Weighted TNSS ranged from 0 to 16, with a higher score indicating more severe total nasal symptoms. The Baseline TNSS was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-Baseline Weighted TNSS was assessed on Day 7 of a treatment period at 30, 60, 90, 120, 150 and 180 minutes after entering the chamber room. Analysis was done by study drug as taken.
    End point type
    Secondary
    End point timeframe
    Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period
    End point values
    		 Montelukast - Efficacy Placebo - Efficacy
    Number of subjects analysed
    213
    211
    Units: score on a scale
    least squares mean (confidence interval 95%)
        30 minutes after entering chamber room
    0.86 (0.67 to 1.05)
    0.91 (0.72 to 1.11)
        60 minutes after entering chamber room
    1.55 (1.31 to 1.79)
    1.63 (1.4 to 1.87)
        90 minutes after entering chamber room
    2.11 (1.83 to 2.38)
    2.04 (1.76 to 2.32)
        120 minutes after entering chamber room
    2.17 (1.87 to 2.47)
    2.17 (1.87 to 2.47)
        150 minutes after entering chamber room
    2.21 (1.92 to 2.51)
    2.16 (1.86 to 2.46)
        180 minutes after entering chamber room
    2.22 (1.91 to 2.53)
    2.21 (1.9 to 2.52)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Nasal Congestion Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room

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    End point title
    		 Change from Baseline in Nasal Congestion Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room
    End point description
    The Nasal Congestion Score was assessed as 0 = No symptoms of nasal congestion to 4 = Completely obstructed all day. The possible Nasal Congestion Score ranged from 0 to 4, with a higher score indicating more severe nasal congestion.The Nasal Congestion Score was assessed on Day 7 prior to entering the chamber room and at 30, 60, 90, 120, 150 and 180 minutes after entering the chamber room. Analysis was done by study drug as taken.
    End point type
    Secondary
    End point timeframe
    Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period
    End point values
    		 Montelukast - Efficacy Placebo - Efficacy
    Number of subjects analysed
    213
    211
    Units: score on a scale
    least squares mean (confidence interval 95%)
        30 minutes after entering chamber room
    0.32 (0.24 to 0.39)
    0.33 (0.25 to 0.4)
        60 minutes after entering chamber room
    0.55 (0.46 to 0.63)
    0.56 (0.48 to 0.65)
        90 minutes after entering chamber room
    0.74 (0.64 to 0.85)
    0.73 (0.63 to 0.83)
        120 minutes after entering chamber room
    0.8 (0.68 to 0.91)
    0.82 (0.7 to 0.94)
        150 minutes after entering chamber room
    0.83 (0.72 to 0.95)
    0.81 (0.7 to 0.93)
        180 minutes after entering chamber room
    0.83 (0.7 to 0.95)
    0.81 (0.69 to 0.93)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Nasal Discharge Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room

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    End point title
    		 Change from Baseline in Nasal Discharge Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room
    End point description
    The Nasal Discharge Score was assessed as 0 = 0 times participant blew his/her nose to 4 = 21 or more times participant blew his/her nose. The possible Nasal Discharge Score ranged from 0 to 4, with a higher score indicating more severe nasal discharge. The Nasal Discharge Score was assessed on Day 7 prior to entering the chamber room and at 30, 60, 90, 120, 150 and 180 minutes after entering the chamber room. Analysis was done by study drug as taken.
    End point type
    Secondary
    End point timeframe
    Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period
    End point values
    		 Montelukast - Efficacy Placebo - Efficacy
    Number of subjects analysed
    213
    211
    Units: score on a scale
    least squares mean (confidence interval 95%)
        30 minutes after entering chamber room
    0.13 (0.08 to 0.18)
    0.17 (0.12 to 0.22)
        60 minutes after entering chamber room
    0.27 (0.21 to 0.34)
    0.33 (0.27 to 0.4)
        90 minutes after entering chamber room
    0.39 (0.32 to 0.46)
    0.38 (0.31 to 0.45)
        120 minutes after entering chamber room
    0.34 (0.27 to 0.4)
    0.36 (0.29 to 0.42)
        150 minutes after entering chamber room
    0.31 (0.24 to 0.37)
    0.32 (0.25 to 0.39)
        180 minutes after entering chamber room
    0.33 (0.26 to 0.4)
    0.37 (0.3 to 0.44)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Sneezing Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room

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    End point title
    		 Change from Baseline in Sneezing Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room
    End point description
    The Sneezing Score was assessed as 0 = 0 times participant sneezed to 4 = 21 or more times participant sneezed. The possible Sneezing Score ranged from 0 to 4, with a higher score indicating more severe sneezing. The Sneezing Score was assessed on Day 7 prior to entering the chamber room and at 30, 60, 90, 120, 150 and 180 minutes after entering the chamber room. Analysis was done by study drug as taken.
    End point type
    Secondary
    End point timeframe
    Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period
    End point values
    		 Montelukast - Efficacy Placebo - Efficacy
    Number of subjects analysed
    213
    211
    Units: score on a scale
    least squares mean (confidence interval 95%)
        30 minutes after entering chamber room
    0.09 (0.05 to 0.14)
    0.09 (0.05 to 0.14)
        60 minutes after entering chamber room
    0.18 (0.12 to 0.23)
    0.18 (0.12 to 0.23)
        90 minutes after entering chamber room
    0.23 (0.16 to 0.29)
    0.2 (0.13 to 0.26)
        120 minutes after entering chamber room
    0.25 (0.19 to 0.31)
    0.17 (0.11 to 0.23)
        150 minutes after entering chamber room
    0.24 (0.18 to 0.3)
    0.21 (0.15 to 0.27)
        180 minutes after entering chamber room
    0.23 (0.17 to 0.3)
    0.23 (0.16 to 0.29)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 14 days after last dose of study drug (Up to 5 weeks)
    Adverse event reporting additional description
    The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one dose of study drug. AEs are reported by dose taken at time of the AE and not by randomly assigned sequence.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants receive placebo for 7 days, regardless of sequence.

    Reporting group title
    Montelukast
    Reporting group description
    		 Participants receive montelukast 5 mg for 7 days, regardless of sequence.

    Serious adverse events
    		 Placebo Montelukast
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 218 (0.00%)
    0 / 216 (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: 5%
    Non-serious adverse events
    		 Placebo Montelukast
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 218 (7.80%)
    10 / 216 (4.63%)
    Investigations
    Protein urine present
         subjects affected / exposed
    17 / 218 (7.80%)
    10 / 216 (4.63%)
         occurrences all number
    17
    10

    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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