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    Clinical Trial Results:
    An 8 Week Study to Evaluate the Effectiveness of Adding Montelukast to Inhaled Corticosteroid (ICS) to the ICS/Long-Acting Beta 2-Agonist Therapy in Adult Subjects With Asthma and Allergic Rhinitis

    Summary
    EudraCT number
    		 2014-004775-23
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    30 Jan 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Mar 2016
    First version publication date
    30 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    0476-383
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00545844
    WHO universal trial number (UTN)
    		 -
    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
    30 Jan 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Jan 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jan 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Effectiveness of adding montelukast to inhaled corticosteroids in adult participants with both uncontrolled asthma and allergic rhinitis.
    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
    02 Apr 2007
    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: 313
    Worldwide total number of subjects
    313
    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)
    13
    Adults (18-64 years)
    252
    From 65 to 84 years
    48
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The first 25 asthmatic participants seen consecutively at each site were invited to participate. Treatment phase: From the Survey population, blocks of 8 were allowed to participate. All participants took 1 tablet of montelukast 10 mg once a day at bedtime. First participant in: 02-APR-2007 Last participant out: 25-JAN-2008

    Pre-assignment
    Screening details
    		 The anticipated Enrollment was 440, with an expected dropout rate of 20% over the 8-week period, thus 369 patients should complete the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    This was an open-label study.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 All Patients
    Arm description
    		 Participants took montelukast sodium, 10 mg, one tablet once a day for 8 weeks as add on therapy to usual current asthma controller treatment. Participants with comorbid allergic rhinitis and uncontrolled asthma were invited to participate in the treatment phase of the study. Of the 1004 participants who completed the survey phase, there were 319 eligible participants who advanced and participated in the treatment phase. Of the 319 eligible participants who advanced to the treatment phase 6 did not meet inclusion criteria leaving 313 patients.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Montelukast sodium
    Investigational medicinal product code
    Other name
    SINGULAIR®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Montelukast sodium 10 mg tablet taken by mouth at bedtime.

    Arm title
    		 Treatment Phase (All Patients) Week 8
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Montelukast sodium
    Investigational medicinal product code
    Other name
    SINGULAIR®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Montelukast sodium 10 mg tablet taken by mouth at bedtime.

    Arm title
    		 Treatment Phase (All Patients) Week 0
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Montelukast sodium
    Investigational medicinal product code
    Other name
    SINGULAIR®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Montelukast sodium 10 mg tablet taken by mouth at bedtime.

    Number of subjects in period 1
    		All Patients Treatment Phase (All Patients) Week 8 Treatment Phase (All Patients) Week 0
    Started
    313
    301
    313
    Completed
    301
    301
    301
    Not completed
    12
    0
    12
         Consent withdrawn by subject
    2
    -
    2
         Lost to follow-up
    9
    -
    9
         Protocol deviation
    1
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    All Patients
    Reporting group description
    		 Participants took montelukast sodium, 10 mg, one tablet once a day for 8 weeks as add on therapy to usual current asthma controller treatment. Participants with comorbid allergic rhinitis and uncontrolled asthma were invited to participate in the treatment phase of the study. Of the 1004 participants who completed the survey phase, there were 319 eligible participants who advanced and participated in the treatment phase. Of the 319 eligible participants who advanced to the treatment phase 6 did not meet inclusion criteria leaving 313 patients.

    Reporting group values
    		 All Patients Total
    Number of subjects
    		 313 313
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 13 13
        Adults (18-64 years)
    		 252 252
        From 65-84 years
    		 48 48
        85 years and over
    		 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 46.1 ± 17.2 -
    Gender, Male/Female
    Units: Participants
        Female
    		 199 199
        Male
    		 114 114
    Inhaled Corticosteroids or Inhaled Corticosteroids / Long-Acting Beta 2-Agonist Use
    Units: Subjects
        Inhaled Corticosteroids Only
    		 154 154
        Inhaled Corticosteroids/Long-Acting Beta 2-Agonist
    		 153 153
        Missing
    		 6 6
    Allergic Rhinitis Diagnosis Duration
    Units: Months
        arithmetic mean (standard deviation)
    		 131.4 ± 135.4 -
    Asthma Diagnosis Duration
    Units: Months
        arithmetic mean (standard deviation)
    		 147.6 ± 139 -

    End points

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    End points reporting groups
    Reporting group title
    All Patients
    Reporting group description
    		 Participants took montelukast sodium, 10 mg, one tablet once a day for 8 weeks as add on therapy to usual current asthma controller treatment. Participants with comorbid allergic rhinitis and uncontrolled asthma were invited to participate in the treatment phase of the study. Of the 1004 participants who completed the survey phase, there were 319 eligible participants who advanced and participated in the treatment phase. Of the 319 eligible participants who advanced to the treatment phase 6 did not meet inclusion criteria leaving 313 patients.

    Reporting group title
    Treatment Phase (All Patients) Week 8
    Reporting group description
    		 -

    Reporting group title
    Treatment Phase (All Patients) Week 0
    Reporting group description
    		 -

    Subject analysis set title
    Treatment Phase (All Patients) Week 0
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All participants at Week 0.

    Subject analysis set title
    Treatment Phase (All Patients) Week 8
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All participants at Week 8.

    Subject analysis set title
    Treatment Phase (All Patients) Week 8
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All participants at Week 8.

    Subject analysis set title
    Treatment Phase (All Patients) Week 8
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All participants at Week 8.

    Primary: Asthma Control

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    End point title
    		 Asthma Control [1]
    End point description
    Asthma control was assessed by the Canadian Asthma Consensus Guidelines at week 0 and week 8. Participants were considered uncontrolled if they answered “yes” to at least 2 of the 8 asthma control parameters.
    End point type
    Primary
    End point timeframe
    8 weeks (from Week 0 to Week 8)
    Notes
    [1] - 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: Only descriptive statistics were to be provided.
    End point values
    		 Treatment Phase (All Patients) Week 0 Treatment Phase (All Patients) Week 8
    Number of subjects analysed
    313
    301 [2]
    Units: Participants
    number (not applicable)
        Uncontrolled
    312
    72
        Controlled
    0
    229
        Missing
    1
    0
    Notes
    [2] - Results are based on 301 participants in the Intent-to-Treat (ITT) population with results at Week 8
    No statistical analyses for this end point

    Secondary: The mean change in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) overall score

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    End point title
    		 The mean change in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) overall score
    End point description
    Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) consists of 14 questions to assess participant's overall quality of life related to allergic rhinitis on a scale of 0 (least impairment) to 6 (greatest impairment). The score is the mean of the 14 questions, ranging from 0 to 6. Change is computed as Week 8 score – Week 0 score.
    End point type
    Secondary
    End point timeframe
    8 weeks (from Week 0 to Week 8)
    End point values
    		 Treatment Phase (All Patients) Week 0 Treatment Phase (All Patients) Week 8
    Number of subjects analysed
    313 [3]
    286 [4]
    Units: Units on a Scale
        arithmetic mean (standard deviation)
    0 ± 0
    -1.45 ± 1.35
    Notes
    [3] - Baseline is set to zero for the purpose of this analysis.
    [4] - Result based on 286 participants in the ITT population with MiniRQLQ data at Week 8.
    Statistical analysis title
    		 Mean Change in Mini Rhinoconjunctivitis Quality
    Statistical analysis description
    Change from baseline at Week 8
    Comparison groups
    Treatment Phase (All Patients) Week 8 v Treatment Phase (All Patients) Week 0
    Number of subjects included in analysis
    599
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [5] - A total of 286 participants were included in the Week 8 analysis.

    Secondary: Effectiveness of Montelukast Therapy Used in Combination With Inhaled Corticosteroids or Inhaled Corticosteroids / Long-Acting Beta 2-Agonist in Improving the Symptoms of Asthma Using the Asthma Control Questionnaire (ACQ)

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    End point title
    		 Effectiveness of Montelukast Therapy Used in Combination With Inhaled Corticosteroids or Inhaled Corticosteroids / Long-Acting Beta 2-Agonist in Improving the Symptoms of Asthma Using the Asthma Control Questionnaire (ACQ)
    End point description
    The Asthma Control Questionnaire consists of 7 specific questions that were used to assess participant's asthma control at Week 0 and Week 8. The mean score per question is used to determine the level of control, with a final score ranging from 0 (well-controlled) to 6 (extremely poorly-controlled) units on a scale.
    End point type
    Secondary
    End point timeframe
    8 weeks (from Week 0 to Week 8)
    End point values
    		 Treatment Phase (All Patients) Week 0 Treatment Phase (All Patients) Week 8
    Number of subjects analysed
    313
    300 [6]
    Units: Units on a Scale
        arithmetic mean (standard deviation)
    2.03 ± 0.8
    0.92 ± 0.8
    Notes
    [6] - 300 participants in the ITT population completed the ACQ at Week 8.
    Statistical analysis title
    		 Change from baseline in ACQ
    Statistical analysis description
    Change from baseline at Week 8
    Comparison groups
    Treatment Phase (All Patients) Week 0 v Treatment Phase (All Patients) Week 8
    Number of subjects included in analysis
    613
    Analysis specification
    Pre-specified
    Analysis type
    		 other [7]
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [7] - 300 participants were included in the Week 8 analysis.

    Other pre-specified: Patient Global Satisfaction

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    End point title
    		 Patient Global Satisfaction
    End point description
    At week 0 and week 8, patients were asked to complete a single question describing how satisfied they were regarding their asthma controller medication.
    End point type
    Other pre-specified
    End point timeframe
    8 weeks (from Week 0 to Week 8)
    End point values
    		 Treatment Phase (All Patients) Week 0 Treatment Phase (All Patients) Week 8
    Number of subjects analysed
    313
    301 [8]
    Units: Participants
    number (not applicable)
        Very satisfied
    24
    136
        Satisfied
    77
    110
        Neither satisfied or dissatisfied
    104
    36
        Dissatisfied
    97
    16
        Very dissatisfied
    11
    1
        Missing
    0
    2
    Notes
    [8] - Results are based on 301 participants in the ITT population that completed Week 8.
    Statistical analysis title
    		 Change in patient satisfaction
    Statistical analysis description
    McNemar-Bowker test is McNemar chi-squared statistic for binary matched pairs, with Bowker chi-squared fit test of symmetry model (tests all rows of data) (cf. Agresti, 2007)
    Comparison groups
    Treatment Phase (All Patients) Week 0 v Treatment Phase (All Patients) Week 8
    Number of subjects included in analysis
    614
    Analysis specification
    Pre-specified
    Analysis type
    		 other [9]
    P-value
    		 < 0.001
    Method
    		 McNemar-Bowker
    Confidence interval
    Notes
    [9] - 301 participants were included in the Week 8 analysis.

    Other pre-specified: Physician Global Satisfaction

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    End point title
    		 Physician Global Satisfaction
    End point description
    At week 0 and week 8, physicians were asked to complete a single question describing how satisfied they were regarding their patient’s asthma controller medication.
    End point type
    Other pre-specified
    End point timeframe
    8 weeks (from Week 0 to Week 8)
    End point values
    		 Treatment Phase (All Patients) Week 0 Treatment Phase (All Patients) Week 8
    Number of subjects analysed
    313
    301 [10]
    Units: Participants
    number (not applicable)
        Very satisfied
    7
    135
        Satisfied
    54
    110
        Neither satisfied or dissatisfied
    104
    30
        Dissatisfied
    142
    25
        Very dissatisfied
    4
    1
        Missing
    2
    0
    Notes
    [10] - Results are based on the 301 participants in the ITT population that completed Week 8.
    Statistical analysis title
    		 Change in Physician Global Satisfaction
    Statistical analysis description
    McNemar-Bowker test is McNemar chi-squared statistic for binary matched pairs, with Bowker chi-squared fit test of symmetry model (tests all rows of data) (cf. Agresti, 2007)
    Comparison groups
    Treatment Phase (All Patients) Week 0 v Treatment Phase (All Patients) Week 8
    Number of subjects included in analysis
    614
    Analysis specification
    Pre-specified
    Analysis type
    		 other [11]
    P-value
    		 < 0.001
    Method
    		 McNemar-Bowker
    Confidence interval
    Notes
    [11] - 301 participants were included in the Week 8 analysis.

    Other pre-specified: Patient Global Allergic Rhinitis Symptoms Assessment

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    End point title
    		 Patient Global Allergic Rhinitis Symptoms Assessment
    End point description
    At week 0 and week 8, patients were asked to complete one question describing their perception of their allergic rhinitis symptoms.
    End point type
    Other pre-specified
    End point timeframe
    8 weeks (from Week 0 to Week 8)
    End point values
    		 Treatment Phase (All Patients) Week 0 Treatment Phase (All Patients) Week 8
    Number of subjects analysed
    313
    301 [12]
    Units: Participants
    number (not applicable)
        A non-issue as I do not have these symptoms
    11
    41
        Not really bothersome
    35
    129
        Bothersome a little of the time
    73
    77
        Bothersome some of the time
    91
    40
        Bothersome a good bit of the time
    94
    13
        Missing
    9
    1
    Notes
    [12] - Results are based on 301 participants in the ITT population that completed Week 8.
    Statistical analysis title
    		 Change in Patient Global Allergic Rhinitis
    Statistical analysis description
    McNemar-Bowker test is McNemar chi-squared statistic for binary matched pairs, with Bowker chi-squared fit test of symmetry model (tests all rows of data) (cf. Agresti, 2007)
    Comparison groups
    Treatment Phase (All Patients) Week 0 v Treatment Phase (All Patients) Week 8
    Number of subjects included in analysis
    614
    Analysis specification
    Pre-specified
    Analysis type
    		 other [13]
    P-value
    		 < 0.001
    Method
    		 McNemar-Bowker
    Confidence interval
    Notes
    [13] - 301 participants were included in the Week 8 analysis.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 10 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    All Patients
    Reporting group description
    		 -

    Serious adverse events
    		 All Patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 313 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0.3%
    Non-serious adverse events
    		 All Patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 313 (3.51%)
    Cardiac disorders
    Palpitations
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 313 (0.32%)
         occurrences all number
    1
    Immune system disorders
    Allergic reaction Not Otherwise Specified
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 313 (0.32%)
         occurrences all number
    1
    Gastrointestinal disorders
    Diarrhea
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 313 (0.32%)
         occurrences all number
    1
    Nausea
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 313 (0.32%)
         occurrences all number
    1
    Swollen tongue
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 313 (0.32%)
         occurrences all number
    1
    Upset stomach
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 313 (0.32%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma exacerbation
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 313 (0.32%)
         occurrences all number
    1
    Nasal congestion
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 313 (0.32%)
         occurrences all number
    1
    Wheezing
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 313 (0.32%)
         occurrences all number
    1
    Asthma aggravated
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 313 (0.32%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Rash
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 313 (0.32%)
         occurrences all number
    1
    Psychiatric disorders
    Insomnia
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 313 (0.32%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Muscular pain
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 313 (0.32%)
         occurrences all number
    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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