Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Phase-II, Randomized, Placebo-Controlled, Parallel-Group Clinical Trial to Study the Efficacy and Safety of MK-1029 in Adult Subjects with Persistent Asthma That is Uncontrolled While Receiving Montelukast.

    Summary
    EudraCT number
    		 2015-005054-36
    Trial protocol
    		 PL  
    Global end of trial date
    06 Sep 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Aug 2018
    First version publication date
    26 Aug 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    1029-015
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02720081
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    06 Sep 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Sep 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this trial is to compare the safety, tolerability, and efficacy of adding MK-1029 to montelukast in adults with persistent asthma that is uncontrolled while receiving montelukast alone. Participants will have a specific genetic marker for clinical efficacy of MK-1029. The primary hypothesis is that when added to montelukast, treatment with MK-1029 is superior to placebo, as demonstrated by an increase in forced expiratory volume in one second (FEV1), measured as the average change from baseline at the end of Week 4 and Week 6 of treatment.
    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: short-acting beta-agonist via metered-dose inhaler, as albuterol/salbutamol 90 or 100 mcg per inhalation, was to be provided by sites to participants for potential use at home as a rescue medication.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 May 2016
    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
    Guatemala: 20
    Country: Number of subjects enrolled
    Japan: 77
    Country: Number of subjects enrolled
    Malaysia: 13
    Country: Number of subjects enrolled
    Poland: 20
    Country: Number of subjects enrolled
    South Africa: 12
    Worldwide total number of subjects
    142
    EEA total number of subjects
    20
    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)
    0
    Adults (18-64 years)
    137
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Inclusion Criteria: symptoms of persistent asthma for at least one year; history of asthma treatments including "as-needed" inhaled short-acting beta-agonists: stable doses of inhaled corticosteroids (ICS), combination ICS/long-acting (inhaled) Beta2-adrenergic agonist (LABA) and/or oral asthma controller(s).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MK-1029 150 mg + Montelukast 10 mg
    Arm description
    		 Participants receive single-blind MK-1029 matching-image placebo + open-label montelukast 10 mg for a 2 to 4 week run-in period while discontinuing or tapering off asthma controller medications. Participants receive double-blind MK-1029 150 mg + montelukast 10 mg for 6 weeks in the treatment period. Participants can use rescue medication during both periods as needed.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-1029
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    150 mg tablet administered orally, once a day (QD), at bedtime

    Investigational medicinal product name
    Montelukast
    Investigational medicinal product code
    Other name
    SINGULAIR® Montelukast sodium
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg tablet administered orally, QD, at bedtime

    Investigational medicinal product name
    Albuterol/Salbutamol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour, solution
    Routes of administration
    Oral use
    Dosage and administration details
    1 or 2 inhalations (90 mcg - 100 mcg per inhalation) 4 times a day (QID) as needed (PRN) as a Rescue Medication

    Investigational medicinal product name
    MK-1029 Matching-image Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching-image placebo tablet administered orally, QD, at bedtime

    Arm title
    		 MK-1029 Placebo + Montelukast 10 mg
    Arm description
    		 Participants receive single-blind MK-1029 matching-image placebo + open-label montelukast 10 mg for a 2 to 4 week run-in period while discontinuing or tapering off asthma controller medications. Participants receive double-blind MK-1029 matching-image placebo + montelukast 10 mg for 6 weeks in the treatment period. Participants can use rescue medication during both periods as needed.
    Arm type
    		 Placebo

    Investigational medicinal product name
    MK-1029 Matching-image Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching-image placebo tablet administered orally, QD, at bedtime

    Investigational medicinal product name
    Montelukast
    Investigational medicinal product code
    Other name
    SINGULAIR® Montelukast sodium
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg tablet administered orally, QD, at bedtime

    Investigational medicinal product name
    Albuterol/Salbutamol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour, solution
    Routes of administration
    Oral use
    Dosage and administration details
    1 or 2 inhalations (90 mcg - 100 mcg per inhalation) 4 times a day (QID) as needed (PRN) as a Rescue Medication

    Number of subjects in period 1
    		MK-1029 150 mg + Montelukast 10 mg MK-1029 Placebo + Montelukast 10 mg
    Started
    72
    70
    Treated
    70
    69
    Completed
    68
    66
    Not completed
    4
    4
         Adverse event, non-fatal
    -
    3
         Protocol deviation
    4
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    MK-1029 150 mg + Montelukast 10 mg
    Reporting group description
    		 Participants receive single-blind MK-1029 matching-image placebo + open-label montelukast 10 mg for a 2 to 4 week run-in period while discontinuing or tapering off asthma controller medications. Participants receive double-blind MK-1029 150 mg + montelukast 10 mg for 6 weeks in the treatment period. Participants can use rescue medication during both periods as needed.

    Reporting group title
    MK-1029 Placebo + Montelukast 10 mg
    Reporting group description
    		 Participants receive single-blind MK-1029 matching-image placebo + open-label montelukast 10 mg for a 2 to 4 week run-in period while discontinuing or tapering off asthma controller medications. Participants receive double-blind MK-1029 matching-image placebo + montelukast 10 mg for 6 weeks in the treatment period. Participants can use rescue medication during both periods as needed.

    Reporting group values
    		 MK-1029 150 mg + Montelukast 10 mg MK-1029 Placebo + Montelukast 10 mg Total
    Number of subjects
    		 72 70 142
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 44.4 ( 12.1 ) 42.2 ( 13.0 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 41 46 87
        Male
    		 31 24 55
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 2 2 4
        Asian
    		 48 42 90
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 0 0 0
        White
    		 10 16 26
        More than one race
    		 12 10 22
        Unknown or Not Reported
    		 0 0 0
    C Alleles at the pre-specified single nucleotide polymorphism (SNP)
    C Alleles at the pre-specified SNP is the proposed genetic marker for response to MK-1029 for the treatment of asthma.
    Units: Subjects
        1 copy
    		 48 47 95
        2 copies
    		 24 23 47
    Prior inhaled corticosteroid use
    Units: Subjects
        Yes
    		 52 54 106
        No
    		 20 16 36
    Pre beta-agonist (β-agonist) forced expiratory volume in one second Predicted
    If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. Analysis population includes all randomized participants who received at least one dose of study drug: MK-1029 150 mg + Montelukast 10 mg, n=70; MK-1029 Placebo + Montelukast 10 mg, n=69.
    Units: Liter (L)
        arithmetic mean (standard deviation)
    		 2.251 ( 0.572 ) 2.243 ( 0.631 ) -
    Forced Expiratory Volume in one second (FEV1)
    FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second. Analysis population includes all randomized participants who received at least one dose of study drug: MK-1029 150 mg + Montelukast 10 mg, n=70; MK-1029 Placebo + Montelukast 10 mg, n=69.
    Units: Liters
        arithmetic mean (standard deviation)
    		 2.264 ( 0.566 ) 2.234 ( 0.612 ) -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    MK-1029 150 mg + Montelukast 10 mg
    Reporting group description
    		 Participants receive single-blind MK-1029 matching-image placebo + open-label montelukast 10 mg for a 2 to 4 week run-in period while discontinuing or tapering off asthma controller medications. Participants receive double-blind MK-1029 150 mg + montelukast 10 mg for 6 weeks in the treatment period. Participants can use rescue medication during both periods as needed.

    Reporting group title
    MK-1029 Placebo + Montelukast 10 mg
    Reporting group description
    		 Participants receive single-blind MK-1029 matching-image placebo + open-label montelukast 10 mg for a 2 to 4 week run-in period while discontinuing or tapering off asthma controller medications. Participants receive double-blind MK-1029 matching-image placebo + montelukast 10 mg for 6 weeks in the treatment period. Participants can use rescue medication during both periods as needed.

    Primary: Average change from Baseline in FEV1 at Week 4 and Week 6

    		 Close Top of page
    End point title
    		 Average change from Baseline in FEV1 at Week 4 and Week 6
    End point description
    FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second. Pulmonary function tests were to be performed by participants in the morning before dosing. Data presented represent the average change from baseline for Week 4 plus the average change from baseline for Week 6. Analysis population consists of randomized participants who received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Before the first dose (Baseline) and at the end of Weeks 4 and 6 of treatment
    End point values
    		 MK-1029 150 mg + Montelukast 10 mg MK-1029 Placebo + Montelukast 10 mg
    Number of subjects analysed
    70
    69
    Units: Liter
        least squares mean (confidence interval 95%)
    0.152 (0.088 to 0.217)
    0.046 (-0.020 to 0.111)
    Statistical analysis title
    		 Between-group comparison
    Comparison groups
    MK-1029 150 mg + Montelukast 10 mg v MK-1029 Placebo + Montelukast 10 mg
    Number of subjects included in analysis
    139
    Analysis specification
    Pre-specified
    Analysis type
    		 [1]
    P-value
    		 = 0.023
    Method
    		 Constrained longitudinal data analysis
    Parameter type
    		 Difference in least squares means
    Point estimate
    0.107
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.015
         upper limit
    		 0.199
    Notes
    [1] - Terms for treatment, time, interaction of time by treatment, number of C alleles at the pre-specified SNP, and prior inhaled corticosteroid use.

    Secondary: Percentage of days with worsening asthma average over Weeks 3 to 6

    		 Close Top of page
    End point title
    		 Percentage of days with worsening asthma average over Weeks 3 to 6
    End point description
    A day with worsening asthma was defined as any day during which any of the following occurred: a decrease from baseline in morning (AM) peak expiratory flow (PEF) of more than 20%; AM PEF less than 180 liters/minute (L/min); an increase in β-agonist use of more than 70% (and a minimum increase of at least 2 puffs); an increase from baseline in daytime asthma symptom score of more than 50%; overnight asthma symptom of: Awake “all night”; an asthma attack, as defined by any day when one or more of the following events due to asthma has occurred: corticosteroid use (systemic); unscheduled visit to the doctor or urgent care clinic; unscheduled visit to the emergency department; and/or hospitalization. Analysis population consists of randomized participants who received at least 1 dose of study drug and had at least 80% of days with a complete diary during Weeks 3 to 6. A diary is considered complete if none of the above 6 components used to determine asthma worsening are missing.
    End point type
    Secondary
    End point timeframe
    Up to 4 weeks
    End point values
    		 MK-1029 150 mg + Montelukast 10 mg MK-1029 Placebo + Montelukast 10 mg
    Number of subjects analysed
    52
    44
    Units: Percentage of days
        least squares mean (confidence interval 95%)
    16.970 (10.115 to 23.826)
    21.746 (14.291 to 29.201)
    Statistical analysis title
    		 Between-group comparison
    Comparison groups
    MK-1029 150 mg + Montelukast 10 mg v MK-1029 Placebo + Montelukast 10 mg
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    		 [2]
    P-value
    		 = 0.352
    Method
    		 ANOVA
    Parameter type
    		 Difference in least squares means
    Point estimate
    -4.775
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.92
         upper limit
    		 5.37
    Notes
    [2] - Terms for treatment, number of C alleles at the pre-specified SNP, and prior inhaled corticosteroid use.

    Secondary: Percentage of participants who experienced an adverse event (AE)

    		 Close Top of page
    End point title
    		 Percentage of participants who experienced an adverse event (AE)
    End point description
    An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Analysis population included all randomized participants who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Up to 8 weeks
    End point values
    		 MK-1029 150 mg + Montelukast 10 mg MK-1029 Placebo + Montelukast 10 mg
    Number of subjects analysed
    70
    69
    Units: Percentage of participants
        number (not applicable)
    25.7
    26.1
    Statistical analysis title
    		 Between-group comparison
    Statistical analysis description
    Based on Miettinen & Nurminen
    Comparison groups
    MK-1029 150 mg + Montelukast 10 mg v MK-1029 Placebo + Montelukast 10 mg
    Number of subjects included in analysis
    139
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in percentages
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15
         upper limit
    		 14.3

    Secondary: Percentage of participants who discontinued study drug due to an AE

    		 Close Top of page
    End point title
    		 Percentage of participants who discontinued study drug due to an AE
    End point description
    An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Analysis population included all randomized participants who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Up to 6 weeks
    End point values
    		 MK-1029 150 mg + Montelukast 10 mg MK-1029 Placebo + Montelukast 10 mg
    Number of subjects analysed
    70
    69
    Units: Percentage of participants
        number (not applicable)
    0.0
    4.3
    Statistical analysis title
    		 Between-group comparison
    Statistical analysis description
    Based on Miettinen & Nurminen
    Comparison groups
    MK-1029 150 mg + Montelukast 10 mg v MK-1029 Placebo + Montelukast 10 mg
    Number of subjects included in analysis
    139
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in percentages
    Point estimate
    -4.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.1
         upper limit
    		 1

    Secondary: Change from Baseline in alkaline phosphatase (ALP) at Week 6

    		 Close Top of page
    End point title
    		 Change from Baseline in alkaline phosphatase (ALP) at Week 6
    End point description
    Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. Analysis population includes all participants who received at least 1 dose of study drug and had nonmissing change from baseline value at Week 6 for the analysis endpoint, ALP.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 6
    End point values
    		 MK-1029 150 mg + Montelukast 10 mg MK-1029 Placebo + Montelukast 10 mg
    Number of subjects analysed
    70
    68
    Units: IU/L
    arithmetic mean (standard deviation)
        Baseline
    61.16 ( 19.05 )
    67.96 ( 21.17 )
        Change at Week 6
    -0.83 ( 7.68 )
    0.44 ( 9.98 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in alanine aminotransferase (ALT) at Week 6

    		 Close Top of page
    End point title
    		 Change from Baseline in alanine aminotransferase (ALT) at Week 6
    End point description
    Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. Analysis population includes all participants who received at least 1 dose of study drug and had nonmissing change from baseline value at Week 6 for the analysis endpoint, ALT.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 6
    End point values
    		 MK-1029 150 mg + Montelukast 10 mg MK-1029 Placebo + Montelukast 10 mg
    Number of subjects analysed
    70
    68
    Units: IU/L
    arithmetic mean (standard deviation)
        Baseline
    22.33 ( 12.75 )
    19.35 ( 9.77 )
        Change at Week 6
    -0.99 ( 9.84 )
    0.34 ( 6.31 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in aspartate aminotransferase (AST) at Week 6

    		 Close Top of page
    End point title
    		 Change from Baseline in aspartate aminotransferase (AST) at Week 6
    End point description
    Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. Analysis population includes all participants who received at least 1 dose of study drug and had nonmissing change from baseline value at Week 6 for the analysis endpoint, AST.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 6
    End point values
    		 MK-1029 150 mg + Montelukast 10 mg MK-1029 Placebo + Montelukast 10 mg
    Number of subjects analysed
    70
    67
    Units: IU/L
    arithmetic mean (standard deviation)
        Baseline
    23.53 ( 10.28 )
    20.64 ( 7.62 )
        Change at Week 6
    -0.09 ( 12.52 )
    0.76 ( 7.67 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in bilirubin at Week 6

    		 Close Top of page
    End point title
    		 Change from Baseline in bilirubin at Week 6
    End point description
    Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 6 for the analysis endpoint, bilirubin.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 6
    End point values
    		 MK-1029 150 mg + Montelukast 10 mg MK-1029 Placebo + Montelukast 10 mg
    Number of subjects analysed
    70
    68
    Units: mg/dL
    arithmetic mean (standard deviation)
        Baseline
    0.62 ( 0.25 )
    0.54 ( 0.21 )
        Change at Week 6
    -0.00 ( 0.25 )
    -0.01 ( 0.20 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in eosinophil (%) at Week 6

    		 Close Top of page
    End point title
    		 Change from Baseline in eosinophil (%) at Week 6
    End point description
    Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 6 for the analysis endpoint, eosinophil (%).
    End point type
    Secondary
    End point timeframe
    Baseline and Week 6
    End point values
    		 MK-1029 150 mg + Montelukast 10 mg MK-1029 Placebo + Montelukast 10 mg
    Number of subjects analysed
    69
    68
    Units: Percent
    arithmetic mean (standard deviation)
        Baseline
    4.40 ( 4.54 )
    3.58 ( 2.65 )
        Change at Week 6
    0.11 ( 4.29 )
    0.51 ( 1.96 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in neutrophil (%) at Week 6

    		 Close Top of page
    End point title
    		 Change from Baseline in neutrophil (%) at Week 6
    End point description
    Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 6 for the analysis endpoint, neutrophil (%).
    End point type
    Secondary
    End point timeframe
    Baseline and Week 6
    End point values
    		 MK-1029 150 mg + Montelukast 10 mg MK-1029 Placebo + Montelukast 10 mg
    Number of subjects analysed
    69
    68
    Units: Percent
    arithmetic mean (standard deviation)
        Baseline
    59.13 ( 10.30 )
    57.86 ( 10.48 )
        Change at Week 6
    -1.32 ( 10.53 )
    0.12 ( 9.11 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in platelet count at Week 6

    		 Close Top of page
    End point title
    		 Change from Baseline in platelet count at Week 6
    End point description
    Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 6 for the analysis endpoint, platelet count.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 6
    End point values
    		 MK-1029 150 mg + Montelukast 10 mg MK-1029 Placebo + Montelukast 10 mg
    Number of subjects analysed
    68
    68
    Units: 10^9/L
    arithmetic mean (standard deviation)
        Baseline
    256.85 ( 60.83 )
    258.44 ( 70.23 )
        Change at Week 6
    -4.97 ( 30.93 )
    2.65 ( 29.44 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in white blood cell count at Week 6

    		 Close Top of page
    End point title
    		 Change from Baseline in white blood cell count at Week 6
    End point description
    Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 6 for the analysis endpoint, white blood cell count.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 6
    End point values
    		 MK-1029 150 mg + Montelukast 10 mg MK-1029 Placebo + Montelukast 10 mg
    Number of subjects analysed
    69
    68
    Units: 10^9/L
    arithmetic mean (standard deviation)
        Baseline
    6.76 ( 2.55 )
    6.53 ( 1.88 )
        Change at Week 6
    -0.08 ( 2.00 )
    0.09 ( 1.51 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in hematocrit (%) at Week 6

    		 Close Top of page
    End point title
    		 Change from Baseline in hematocrit (%) at Week 6
    End point description
    Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 6 for the analysis endpoint, hematocrit (%).
    End point type
    Secondary
    End point timeframe
    Baseline and Week 6
    End point values
    		 MK-1029 150 mg + Montelukast 10 mg MK-1029 Placebo + Montelukast 10 mg
    Number of subjects analysed
    69
    68
    Units: Percent
    arithmetic mean (standard deviation)
        Baseline
    42.79 ( 3.98 )
    42.64 ( 4.62 )
        Change at Week 6
    -0.10 ( 2.05 )
    -0.33 ( 1.86 )
    No statistical analyses for this end point

    Secondary: Change from baseline in systolic blood pressure at Week 2

    		 Close Top of page
    End point title
    		 Change from baseline in systolic blood pressure at Week 2
    End point description
    Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 2 for the analysis endpoint, systolic blood pressure.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 2
    End point values
    		 MK-1029 150 mg + Montelukast 10 mg MK-1029 Placebo + Montelukast 10 mg
    Number of subjects analysed
    70
    69
    Units: mmHg
    arithmetic mean (standard deviation)
        Baseline
    118.89 ( 16.28 )
    118.83 ( 15.64 )
        Change at Week 2
    -1.61 ( 9.00 )
    -1.23 ( 10.79 )
    No statistical analyses for this end point

    Secondary: Change from baseline in systolic blood pressure at Week 4

    		 Close Top of page
    End point title
    		 Change from baseline in systolic blood pressure at Week 4
    End point description
    Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 4 for the analysis endpoint, systolic blood pressure.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 4
    End point values
    		 MK-1029 150 mg + Montelukast 10 mg MK-1029 Placebo + Montelukast 10 mg
    Number of subjects analysed
    68
    67
    Units: mmHg
    arithmetic mean (standard deviation)
        Baseline
    119.40 ( 16.22 )
    118.82 ( 15.88 )
        Change at Week 4
    -2.13 ( 10.14 )
    -1.99 ( 11.45 )
    No statistical analyses for this end point

    Secondary: Change from baseline in systolic blood pressure at Week 6

    		 Close Top of page
    End point title
    		 Change from baseline in systolic blood pressure at Week 6
    End point description
    Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 6 for the analysis endpoint, systolic blood pressure.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 6
    End point values
    		 MK-1029 150 mg + Montelukast 10 mg MK-1029 Placebo + Montelukast 10 mg
    Number of subjects analysed
    68
    66
    Units: mmHg
    arithmetic mean (standard deviation)
        Baseline
    119.40 ( 16.22 )
    118.77 ( 16.00 )
        Change at Week 6
    -0.34 ( 9.36 )
    -2.26 ( 11.11 )
    No statistical analyses for this end point

    Secondary: Change from baseline in diastolic blood pressure at Week 2

    		 Close Top of page
    End point title
    		 Change from baseline in diastolic blood pressure at Week 2
    End point description
    Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 2 for the analysis endpoint, diastolic blood pressure.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 2
    End point values
    		 MK-1029 150 mg + Montelukast 10 mg MK-1029 Placebo + Montelukast 10 mg
    Number of subjects analysed
    70
    69
    Units: mmHg
    arithmetic mean (standard deviation)
        Baseline
    74.40 ( 10.79 )
    74.45 ( 10.49 )
        Change at Week 2
    -1.31 ( 7.67 )
    -0.97 ( 6.88 )
    No statistical analyses for this end point

    Secondary: Change from baseline in diastolic blood pressure at Week 4

    		 Close Top of page
    End point title
    		 Change from baseline in diastolic blood pressure at Week 4
    End point description
    Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 4 for the analysis endpoint, diastolic blood pressure.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 4
    End point values
    		 MK-1029 150 mg + Montelukast 10 mg MK-1029 Placebo + Montelukast 10 mg
    Number of subjects analysed
    68
    67
    Units: mmHg
    arithmetic mean (standard deviation)
        Baseline
    74.60 ( 10.88 )
    74.42 ( 10.49 )
        Change at Week 4
    -1.56 ( 7.71 )
    -1.60 ( 8.01 )
    No statistical analyses for this end point

    Secondary: Change from baseline in diastolic blood pressure at Week 6

    		 Close Top of page
    End point title
    		 Change from baseline in diastolic blood pressure at Week 6
    End point description
    Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 6 for the analysis endpoint, diastolic blood pressure.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 6
    End point values
    		 MK-1029 150 mg + Montelukast 10 mg MK-1029 Placebo + Montelukast 10 mg
    Number of subjects analysed
    68
    66
    Units: mmHg
    arithmetic mean (standard deviation)
        Baseline
    74.60 ( 10.88 )
    74.29 ( 10.51 )
        Change at Week 6
    -1.18 ( 8.30 )
    -0.95 ( 7.71 )
    No statistical analyses for this end point

    Secondary: Change from baseline in heart rate at Week 2

    		 Close Top of page
    End point title
    		 Change from baseline in heart rate at Week 2
    End point description
    Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 2 for the analysis endpoint, heart rate.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 2
    End point values
    		 MK-1029 150 mg + Montelukast 10 mg MK-1029 Placebo + Montelukast 10 mg
    Number of subjects analysed
    70
    69
    Units: beats/min
    arithmetic mean (standard deviation)
        Baseline
    73.21 ( 10.96 )
    74.20 ( 10.03 )
        Change at Week 2
    -0.60 ( 7.84 )
    0.45 ( 9.38 )
    No statistical analyses for this end point

    Secondary: Change from baseline in heart rate at Week 4

    		 Close Top of page
    End point title
    		 Change from baseline in heart rate at Week 4
    End point description
    Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 4 for the analysis endpoint, heart rate.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 4
    End point values
    		 MK-1029 150 mg + Montelukast 10 mg MK-1029 Placebo + Montelukast 10 mg
    Number of subjects analysed
    68
    67
    Units: beats/min
    arithmetic mean (standard deviation)
        Baseline
    73.25 ( 11.12 )
    73.96 ( 10.01 )
        Change at Week 4
    -1.82 ( 9.18 )
    1.40 ( 9.38 )
    No statistical analyses for this end point

    Secondary: Change from baseline in heart rate at Week 6

    		 Close Top of page
    End point title
    		 Change from baseline in heart rate at Week 6
    End point description
    Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 6 for the analysis endpoint, heart rate.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 6
    End point values
    		 MK-1029 150 mg + Montelukast 10 mg MK-1029 Placebo + Montelukast 10 mg
    Number of subjects analysed
    68
    66
    Units: beats/min
    arithmetic mean (standard deviation)
        Baseline
    73.25 ( 11.12 )
    73.80 ( 10.01 )
        Change at Week 6
    -0.84 ( 8.82 )
    1.06 ( 10.10 )
    No statistical analyses for this end point

    Secondary: Change from baseline in respiratory rate at Week 2

    		 Close Top of page
    End point title
    		 Change from baseline in respiratory rate at Week 2
    End point description
    Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 2 for the analysis endpoint, respiratory rate.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 2
    End point values
    		 MK-1029 150 mg + Montelukast 10 mg MK-1029 Placebo + Montelukast 10 mg
    Number of subjects analysed
    70
    69
    Units: breaths/min
    arithmetic mean (standard deviation)
        Baseline
    16.40 ( 2.61 )
    17.23 ( 3.78 )
        Change at Week 2
    -0.30 ( 1.93 )
    -1.17 ( 3.64 )
    No statistical analyses for this end point

    Secondary: Change from baseline in respiratory rate at Week 4

    		 Close Top of page
    End point title
    		 Change from baseline in respiratory rate at Week 4
    End point description
    Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 4 for the analysis endpoint, respiratory rate.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 4
    End point values
    		 MK-1029 150 mg + Montelukast 10 mg MK-1029 Placebo + Montelukast 10 mg
    Number of subjects analysed
    68
    67
    Units: breaths/min
    arithmetic mean (standard deviation)
        Baseline
    16.43 ( 2.60 )
    17.18 ( 3.82 )
        Change at Week 4
    -0.12 ( 2.58 )
    -0.97 ( 3.24 )
    No statistical analyses for this end point

    Secondary: Change from baseline in respiratory rate at Week 6

    		 Close Top of page
    End point title
    		 Change from baseline in respiratory rate at Week 6
    End point description
    Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 6 for the analysis endpoint, respiratory rate.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 6
    End point values
    		 MK-1029 150 mg + Montelukast 10 mg MK-1029 Placebo + Montelukast 10 mg
    Number of subjects analysed
    68
    66
    Units: breaths/min
    arithmetic mean (standard deviation)
        Baseline
    16.43 ( 2.60 )
    17.20 ( 3.84 )
        Change at Week 6
    -0.09 ( 2.30 )
    -1.17 ( 3.20 )
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Up to 8 weeks
    Adverse event reporting additional description
    Analysis population included all randomized participants who received at least 1 dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    MK-1029 Placebo + Montelukast 10 mg
    Reporting group description
    		 Participants receive single-blind MK-1029 matching-image placebo + open-label montelukast 10 mg for a 2 to 4 week run-in period while discontinuing or tapering off asthma controller medications. Participants receive double-blind MK-1029 matching-image placebo + montelukast 10 mg for 6 weeks in the treatment period. Participants can use rescue medication during both periods as needed.

    Reporting group title
    MK-1029 150 mg + Montelukast 10 mg
    Reporting group description
    		 Participants receive single-blind MK-1029 matching-image placebo + open-label montelukast 10 mg for a 2 to 4 week run-in period while discontinuing or tapering off asthma controller medications. Participants receive double-blind MK-1029 150 mg + montelukast 10 mg for 6 weeks in the treatment period. Participants can use rescue medication during both periods as needed.

    Serious adverse events
    		 MK-1029 Placebo + Montelukast 10 mg MK-1029 150 mg + Montelukast 10 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 70 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 70 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MK-1029 Placebo + Montelukast 10 mg MK-1029 150 mg + Montelukast 10 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 69 (13.04%)
    6 / 70 (8.57%)
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    8 / 69 (11.59%)
    2 / 70 (2.86%)
         occurrences all number
    8
    2
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 69 (5.80%)
    1 / 70 (1.43%)
         occurrences all number
    5
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 69 (0.00%)
    4 / 70 (5.71%)
         occurrences all number
    0
    4

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 May 2017
    Amendment 1: major revisions included clarification of trial design study period, treatment groups, trial medication terminology, study procedures and time frames, and administrative changes.

    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
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Wed May 07 11:45:25 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA