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    Clinical Trial Results:
    Randomized, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of Inhaled Corticosteroid Plus Montelukast Compared with Inhaled Corticosteroid Therapy Alone in Patients with Chronic Asthma

    Summary
    EudraCT number
    2007-006097-28
    Trial protocol
    GB  
    Global end of trial date
    16 Feb 2009

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

    Trial information

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    Trial identification
    Sponsor protocol code
    0476-386
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00666679
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    MK-0476-386: Merck Registration
    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
    16 Feb 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Feb 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Feb 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1) To demonstrate that treatment with montelukast and mometasone (an inhaled corticosteroid), compared with mometasone alone, results in improvement in Forced Expiratory Volume in 1 Second (FEV1) in participants aged 15 to 85 years with chronic asthma; 2) To determine the safety and tolerability of montelukast and mometasone, compared with mometasone alone, in participants aged 15 to 85 years with chronic asthma.
    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. The following additional measure defined for this individual study was in place for the protection of trial subjects: Subjects were provided with open-label inhaled corticosteroid (mometasone furoate) for asthma control throughout the study.
    Background therapy
    Subjects were provided with open-label inhaled corticosteroid (mometasone furoate) for asthma control throughout the study.
    Evidence for comparator
    -
    Actual start date of recruitment
    15 Apr 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
    Canada: 11
    Country: Number of subjects enrolled
    Colombia: 9
    Country: Number of subjects enrolled
    Israel: 26
    Country: Number of subjects enrolled
    Peru: 55
    Country: Number of subjects enrolled
    United States: 33
    Worldwide total number of subjects
    134
    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)
    10
    Adults (18-64 years)
    115
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Participants were screened who were nonsmoking males and females aged 15 to 85 years, had chronic asthma, had an FEV1 50-80% of predicted while withholding short-acting ß-agonist (SABA) and demonstrated reversibility of airway obstruction >12% following SABA administration.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Montelukast+Mometasone then Placebo+Mometasone
    Arm description
    Participants received montelukast 1 mg plus open-label mometasone 220 mcg by inhalation once daily for 2 weeks in Treatment Period 1 and received placebo plus open-label mometasone 220 mcg by inhalation once daily for 2 weeks in Treatment Period 2. Treatment Periods 1 and 2 were separated by a 1-week wash-out period during which all participants received open-label mometasone plus blinded placebo by inhalation.
    Arm type
    Experimental

    Investigational medicinal product name
    montelukast
    Investigational medicinal product code
    Other name
    MK-0476
    Pharmaceutical forms
    Inhalation powder, hard capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    Montelukast 1 mg via dry powder inhaler by inhalation once daily at bedtime

    Investigational medicinal product name
    mometasone
    Investigational medicinal product code
    Other name
    ASMANEX™ TWISTHALER™
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Mometasone 220 mcg via dry powder inhaler by inhalation once daily at bedtime

    Arm title
    Placebo+Mometasone then Montelukast+Mometasone
    Arm description
    Participants received placebo plus open-label mometasone 220 mcg by inhalation once daily for 2 weeks in Treatment Period 1 and received montelukast 1 mg plus open-label mometasone 220 mcg by inhalation once daily for 2 weeks in Treatment Period 2. Treatment Periods 1 and 2 were separated by a 1-week wash-out period during which all participants received open-label mometasone plus blinded placebo by inhalation.
    Arm type
    Placebo

    Investigational medicinal product name
    mometasone
    Investigational medicinal product code
    Other name
    ASMANEX™ TWISTHALER™
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Mometasone 220 mcg via dry powder inhaler by inhalation once daily at bedtime

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder, hard capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    Placebo via dry powder inhaler by inhalation once daily at bedtime

    Number of subjects in period 1
    Montelukast+Mometasone then Placebo+Mometasone Placebo+Mometasone then Montelukast+Mometasone
    Started
    66
    68
    Treated
    65
    67
    Completed
    62
    65
    Not completed
    4
    3
         Protocol deviation
             1
             1
         Consent withdrawn by subject
             1
             -
         Not treated
             1
             1
         Lost to follow-up
             1
             1
    Period 2
    Period 2 title
    Treatment Period 2
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Montelukast+Mometasone then Placebo+Mometasone
    Arm description
    Participants received montelukast 1 mg plus open-label mometasone 220 mcg by inhalation once daily for 2 weeks in Treatment Period 1 and received placebo plus open-label mometasone 220 mcg by inhalation once daily for 2 weeks in Treatment Period 2. Treatment Periods 1 and 2 were separated by a 1-week wash-out period during which all participants received open-label mometasone plus blinded placebo by inhalation.
    Arm type
    Placebo

    Investigational medicinal product name
    mometasone
    Investigational medicinal product code
    Other name
    ASMANEX™ TWISTHALER™
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Mometasone 220 mcg via dry powder inhaler by inhalation once daily at bedtime

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder, hard capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    Placebo via dry powder inhaler by inhalation once daily at bedtime

    Arm title
    Placebo+Mometasone then Montelukast+Mometasone
    Arm description
    Participants received placebo plus open-label mometasone 220 mcg by inhalation once daily for 2 weeks in Treatment Period 1 and received montelukast 1 mg plus open-label mometasone 220 mcg by inhalation once daily for 2 weeks in Treatment Period 2. Treatment Periods 1 and 2 were separated by a 1-week wash-out period during which all participants received open-label mometasone plus blinded placebo by inhalation.
    Arm type
    Experimental

    Investigational medicinal product name
    montelukast
    Investigational medicinal product code
    Other name
    MK-0476
    Pharmaceutical forms
    Inhalation powder, hard capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    Montelukast 1 mg via dry powder inhaler by inhalation once daily at bedtime

    Investigational medicinal product name
    mometasone
    Investigational medicinal product code
    Other name
    ASMANEX™ TWISTHALER™
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Mometasone 220 mcg via dry powder inhaler by inhalation once daily at bedtime

    Number of subjects in period 2
    Montelukast+Mometasone then Placebo+Mometasone Placebo+Mometasone then Montelukast+Mometasone
    Started
    62
    65
    Completed
    61
    64
    Not completed
    1
    1
         Adverse event, serious fatal
             -
             1
         Adverse event, non-fatal
             1
             -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Montelukast+Mometasone then Placebo+Mometasone
    Reporting group description
    Participants received montelukast 1 mg plus open-label mometasone 220 mcg by inhalation once daily for 2 weeks in Treatment Period 1 and received placebo plus open-label mometasone 220 mcg by inhalation once daily for 2 weeks in Treatment Period 2. Treatment Periods 1 and 2 were separated by a 1-week wash-out period during which all participants received open-label mometasone plus blinded placebo by inhalation.

    Reporting group title
    Placebo+Mometasone then Montelukast+Mometasone
    Reporting group description
    Participants received placebo plus open-label mometasone 220 mcg by inhalation once daily for 2 weeks in Treatment Period 1 and received montelukast 1 mg plus open-label mometasone 220 mcg by inhalation once daily for 2 weeks in Treatment Period 2. Treatment Periods 1 and 2 were separated by a 1-week wash-out period during which all participants received open-label mometasone plus blinded placebo by inhalation.

    Reporting group values
    Montelukast+Mometasone then Placebo+Mometasone Placebo+Mometasone then Montelukast+Mometasone Total
    Number of subjects
    66 68 134
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    6 4 10
        Adults (18-64 years)
    57 58 115
        From 65-84 years
    3 6 9
    Gender categorical
    Units: Subjects
        Female
    37 32 69
        Male
    29 36 65
    FEV1
    FEV1 is the amount of air (in liters) forcibly exhaled during the first second of exhalation. Baseline FEV1 was defined as the last pre ß-agonist value obtained prior to randomization.
    Units: liters
        arithmetic mean (standard deviation)
    ± ± -
    Daytime Asthma Symptoms Score
    In the evening just before going to bed, participants scored their asthma symptoms over the period since arising by answering the following 4 questions in a daily diary: 1) How often did you experience asthma symptoms today?; 2) How much did your asthma symptoms bother you?; 3) How much activity could you do today?; and 4) How often did your asthma affect your activities today? Daytime asthma symptoms were assessed on a 7-point scale (0=best to 6=worst).
    Units: Score on a Scale
        arithmetic mean (standard deviation)
    ± ± -
    Nighttime Asthma Symptoms Score
    In the morning, upon arising, and before taking any medications, participants answered the following question in a daily diary concerning the overnight period: Did you wake up with asthma symptoms? Nighttime asthma symptoms were assessed on a 4-point scale (0=No to 3=Awake all night).
    Units: Score on a Scale
        arithmetic mean (standard deviation)
    ± ± -
    Subject analysis sets

    Subject analysis set title
    Montelukast+Mometasone Full Analysis Set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants who received ≥1 dose montelukast plus mometasone and had Baseline and post-treatment data.

    Subject analysis set title
    Placebo+Mometasone Full Analysis Set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants who received ≥1 dose placebo plus mometasone and had Baseline and post-treatment data.

    Subject analysis set title
    Montelukast+Mometasone Safety Set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants who received ≥1 dose of montelukast plus mometasone

    Subject analysis set title
    Placebo+Mometasone Safety Set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants who received ≥1 dose of placebo plus mometasone

    Subject analysis sets values
    Montelukast+Mometasone Full Analysis Set Placebo+Mometasone Full Analysis Set Montelukast+Mometasone Safety Set Placebo+Mometasone Safety Set
    Number of subjects
    127
    127
    130
    129
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
    Age continuous
    Units:
        
    ±
    ±
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
        Male
    FEV1
    FEV1 is the amount of air (in liters) forcibly exhaled during the first second of exhalation. Baseline FEV1 was defined as the last pre ß-agonist value obtained prior to randomization.
    Units: liters
        arithmetic mean (standard deviation)
    2.18 ± 0.6
    2.19 ± 0.61
    ±
    ±
    Daytime Asthma Symptoms Score
    In the evening just before going to bed, participants scored their asthma symptoms over the period since arising by answering the following 4 questions in a daily diary: 1) How often did you experience asthma symptoms today?; 2) How much did your asthma symptoms bother you?; 3) How much activity could you do today?; and 4) How often did your asthma affect your activities today? Daytime asthma symptoms were assessed on a 7-point scale (0=best to 6=worst).
    Units: Score on a Scale
        arithmetic mean (standard deviation)
    2.1 ± 0.85
    2.12 ± 0.85
    ±
    ±
    Nighttime Asthma Symptoms Score
    In the morning, upon arising, and before taking any medications, participants answered the following question in a daily diary concerning the overnight period: Did you wake up with asthma symptoms? Nighttime asthma symptoms were assessed on a 4-point scale (0=No to 3=Awake all night).
    Units: Score on a Scale
        arithmetic mean (standard deviation)
    0.7 ± 0.46
    0.71 ± 0.46
    ±
    ±

    End points

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    End points reporting groups
    Reporting group title
    Montelukast+Mometasone then Placebo+Mometasone
    Reporting group description
    Participants received montelukast 1 mg plus open-label mometasone 220 mcg by inhalation once daily for 2 weeks in Treatment Period 1 and received placebo plus open-label mometasone 220 mcg by inhalation once daily for 2 weeks in Treatment Period 2. Treatment Periods 1 and 2 were separated by a 1-week wash-out period during which all participants received open-label mometasone plus blinded placebo by inhalation.

    Reporting group title
    Placebo+Mometasone then Montelukast+Mometasone
    Reporting group description
    Participants received placebo plus open-label mometasone 220 mcg by inhalation once daily for 2 weeks in Treatment Period 1 and received montelukast 1 mg plus open-label mometasone 220 mcg by inhalation once daily for 2 weeks in Treatment Period 2. Treatment Periods 1 and 2 were separated by a 1-week wash-out period during which all participants received open-label mometasone plus blinded placebo by inhalation.
    Reporting group title
    Montelukast+Mometasone then Placebo+Mometasone
    Reporting group description
    Participants received montelukast 1 mg plus open-label mometasone 220 mcg by inhalation once daily for 2 weeks in Treatment Period 1 and received placebo plus open-label mometasone 220 mcg by inhalation once daily for 2 weeks in Treatment Period 2. Treatment Periods 1 and 2 were separated by a 1-week wash-out period during which all participants received open-label mometasone plus blinded placebo by inhalation.

    Reporting group title
    Placebo+Mometasone then Montelukast+Mometasone
    Reporting group description
    Participants received placebo plus open-label mometasone 220 mcg by inhalation once daily for 2 weeks in Treatment Period 1 and received montelukast 1 mg plus open-label mometasone 220 mcg by inhalation once daily for 2 weeks in Treatment Period 2. Treatment Periods 1 and 2 were separated by a 1-week wash-out period during which all participants received open-label mometasone plus blinded placebo by inhalation.

    Subject analysis set title
    Montelukast+Mometasone Full Analysis Set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants who received ≥1 dose montelukast plus mometasone and had Baseline and post-treatment data.

    Subject analysis set title
    Placebo+Mometasone Full Analysis Set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants who received ≥1 dose placebo plus mometasone and had Baseline and post-treatment data.

    Subject analysis set title
    Montelukast+Mometasone Safety Set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants who received ≥1 dose of montelukast plus mometasone

    Subject analysis set title
    Placebo+Mometasone Safety Set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Participants who received ≥1 dose of placebo plus mometasone

    Primary: Average Change from Baseline in FEV1 Over 2 Weeks

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    End point title
    Average Change from Baseline in FEV1 Over 2 Weeks
    End point description
    FEV1 is the amount of air (in liters) forcibly exhaled during the first second of exhalation. FEV1 was assessed 1 and 2 weeks after start of treatment. Changes from Baseline in FEV1 at Weeks 1 and 2 of treatment were averaged.
    End point type
    Primary
    End point timeframe
    Over 2-week treatment period
    End point values
    Montelukast+Mometasone Full Analysis Set Placebo+Mometasone Full Analysis Set
    Number of subjects analysed
    127 [1]
    127 [2]
    Units: liters
        least squares mean (confidence interval 95%)
    0.22 (0.15 to 0.3)
    0.17 (0.11 to 0.23)
    Notes
    [1] - Participants who received ≥1 dose montelukast+mometasone and had Baseline and post-treatment data.
    [2] - Participants who received ≥1 dose placebo+mometasone and had Baseline and post-treatment data.
    Statistical analysis title
    Difference in FEV1 After Treatment
    Statistical analysis description
    The difference in least squares (LS) means of Montelukast+Mometasone compared to Placebo+Mometasone for FEV1 was analyzed using a longitudinal data analysis (LDA) model that included terms for treatment, time (Weeks 1 and 2), treatment-by-time interaction, period and Baseline FEV1 as a covariate.
    Comparison groups
    Placebo+Mometasone Full Analysis Set v Montelukast+Mometasone Full Analysis Set
    Number of subjects included in analysis
    254
    Analysis specification
    Pre-specified
    Analysis type
    superiority [3]
    P-value
    = 0.033
    Method
    LDA
    Parameter type
    Difference in LS Means
    Point estimate
    0.05
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0
         upper limit
    0.09
    Notes
    [3] - Based on repeated measures analysis model using repeated measurements at 2 study times (Weeks 1 and 2) with fixed effects for treatment, time, treatment-by-time interaction, period and Baseline FEV1.

    Secondary: Change from Baseline in Daytime Asthma Symptom Score

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    End point title
    Change from Baseline in Daytime Asthma Symptom Score
    End point description
    In the evening just before going to bed, participants scored their asthma symptoms over the period since arising by answering the following 4 questions in a daily diary: 1) How often did you experience asthma symptoms today?; 2) How much did your asthma symptoms bother you?; 3) How much activity could you do today?; and 4) How often did your asthma affect your activities today? Daytime asthma symptoms were assessed on a 7-point scale (0=best to 6=worst) after 1 and 2 weeks of treatment. Changes from baseline in daytime asthma symptom score by day are averaged over the diary days belonging to a specific time period (so Week 1 or 2) and the average over these 2 periods was then obtained in the model. The average change from Baseline in daytime asthma symptom score was calculated.
    End point type
    Secondary
    End point timeframe
    Baseline and 2 Weeks
    End point values
    Montelukast+Mometasone Full Analysis Set Placebo+Mometasone Full Analysis Set
    Number of subjects analysed
    128 [4]
    129 [5]
    Units: Score on a Scale
        least squares mean (confidence interval 95%)
    -0.39 (-0.49 to -0.29)
    -0.24 (-0.35 to -0.12)
    Notes
    [4] - Participants who received ≥1 dose montelukast+mometasone and had Baseline and post-treatment data.
    [5] - Participants who received ≥1 dose placebo+mometasone and had Baseline and post-treatment data.
    Statistical analysis title
    Difference in Daytime Asthma Symptom Scores
    Statistical analysis description
    The difference in LS means of Montelukast+Mometasone compared to Placebo+Mometasone for daytime asthma symptom score was analyzed using an LDA model that included terms for treatment, time (Weeks 1 and 2), treatment-by-time interaction, period and Baseline daytime asthma symptom score as a covariate.
    Comparison groups
    Montelukast+Mometasone Full Analysis Set v Placebo+Mometasone Full Analysis Set
    Number of subjects included in analysis
    257
    Analysis specification
    Pre-specified
    Analysis type
    superiority [6]
    P-value
    = 0.005
    Method
    LDA
    Parameter type
    Difference in LS Means
    Point estimate
    -0.15
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.26
         upper limit
    -0.05
    Notes
    [6] - Based on repeated measures analysis model using repeated measurements at two study times (Weeks 1 and 2) with fixed effects for treatment, time, treatment-by-time interaction, period and Baseline daytime asthma symptom score.

    Secondary: Change from Baseline in Nighttime Asthma Symptom Score

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    End point title
    Change from Baseline in Nighttime Asthma Symptom Score
    End point description
    In the morning, upon arising, and before taking any medications, participants answered the following question in a daily diary concerning the overnight period: Did you wake up with asthma symptoms? Nighttime asthma symptoms were assessed on a 4-point scale (0=No to 3=Awake all night) at Baseline and after 1 and 2 weeks of treatment. Changes from baseline in nighttime asthma symptom score by day are averaged over the diary days belonging to a specific time period (so Week 1 or 2) and the average over these 2 periods was then obtained in the model. The average change from Baseline in nighttime asthma symptom score was calculated.
    End point type
    Secondary
    End point timeframe
    Baseline and 2 Weeks
    End point values
    Montelukast+Mometasone Full Analysis Set Placebo+Mometasone Full Analysis Set
    Number of subjects analysed
    89 [7]
    90 [8]
    Units: Score on a Scale
        least squares mean (confidence interval 95%)
    -0.28 (-0.35 to -0.2)
    -0.18 (-0.28 to -0.09)
    Notes
    [7] - Participants who received ≥1 dose montelukast+mometasone and had Baseline and post-treatment data.
    [8] - Participants who received ≥1 dose placebo+mometasone and had Baseline and post-treatment data.
    Statistical analysis title
    Difference in Nighttime Asthma Symptom Scores
    Statistical analysis description
    The difference in LS means of Montelukast+Mometasone compared to Placebo+Mometasone for nighttime asthma symptom score was analyzed using an LDA model that included terms for treatment, time (Weeks 1 and 2), treatment-by-time interaction, period and Baseline nighttime asthma symptom score as a covariate.
    Comparison groups
    Montelukast+Mometasone Full Analysis Set v Placebo+Mometasone Full Analysis Set
    Number of subjects included in analysis
    179
    Analysis specification
    Pre-specified
    Analysis type
    superiority [9]
    P-value
    = 0.015
    Method
    LDA
    Parameter type
    Difference in LS Means
    Point estimate
    -0.09
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.17
         upper limit
    -0.02
    Notes
    [9] - Based on repeated measures analysis model using repeated measurements at two study times (Weeks 1 and 2) with fixed effects for treatment, time, treatment-by-time interaction, period and Baseline nighttime asthma symptom score.

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Up to 1 week after last dose of study drug in a treatment period (Up to 3 weeks in a treatment period; up to 6 weeks total for the study)
    Adverse event reporting additional description
    Includes all participants who received ≥1 dose of study drug in ≥1 of the 2 study periods. Participants are included in the treatment group corresponding to the study drug they actually received. Adverse events occurring during the washout period between the two treatment periods are counted towards the earlier treatment period.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    11.1
    Reporting groups
    Reporting group title
    Montelukast+Mometasone
    Reporting group description
    Participants who received ≥1 dose of montelukast plus mometasone.

    Reporting group title
    Placebo+Mometasone
    Reporting group description
    Participants who received ≥1 dose of placebo plus mometasone.

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No non-serious adverse events occurred in >5% of participants in either treatment group.
    Serious adverse events
    Montelukast+Mometasone Placebo+Mometasone
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 130 (0.77%)
    1 / 129 (0.78%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 130 (0.77%)
    0 / 129 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Asthma
         subjects affected / exposed
    0 / 130 (0.00%)
    1 / 129 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 130 (0.77%)
    0 / 129 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Montelukast+Mometasone Placebo+Mometasone
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 130 (0.00%)
    0 / 129 (0.00%)

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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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