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
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EudraCT number |
2015-005054-36 |
Trial protocol |
PL |
Global end of trial date |
06 Sep 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
26 Aug 2018
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First version publication date |
26 Aug 2018
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
1029-015
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02720081 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Merck Sharp & Dohme Corp.
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Sponsor organisation address |
2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
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Public contact |
Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
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Scientific contact |
Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
06 Sep 2017
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
06 Sep 2017
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Was the trial ended prematurely? |
No
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General information about the trial
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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.
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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.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
11 May 2016
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Guatemala: 20
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Country: Number of subjects enrolled |
Japan: 77
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Country: Number of subjects enrolled |
Malaysia: 13
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Country: Number of subjects enrolled |
Poland: 20
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Country: Number of subjects enrolled |
South Africa: 12
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Worldwide total number of subjects |
142
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EEA total number of subjects |
20
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
137
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From 65 to 84 years |
5
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||||||||||||||
Pre-assignment
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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
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||||||||
Roles blinded |
Subject, Investigator | |||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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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
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
150 mg tablet administered orally, once a day (QD), at bedtime
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Investigational medicinal product name |
Montelukast
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Investigational medicinal product code |
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Other name |
SINGULAIR® Montelukast sodium
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
10 mg tablet administered orally, QD, at bedtime
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Investigational medicinal product name |
Albuterol/Salbutamol
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Inhalation vapour, solution
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Routes of administration |
Oral use
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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
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Investigational medicinal product name |
MK-1029 Matching-image Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Matching-image placebo tablet administered orally, QD, at bedtime
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Arm title
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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
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Matching-image placebo tablet administered orally, QD, at bedtime
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Investigational medicinal product name |
Montelukast
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Investigational medicinal product code |
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Other name |
SINGULAIR® Montelukast sodium
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
10 mg tablet administered orally, QD, at bedtime
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Investigational medicinal product name |
Albuterol/Salbutamol
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Inhalation vapour, solution
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Routes of administration |
Oral use
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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
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Baseline characteristics reporting groups
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Reporting group title |
MK-1029 150 mg + Montelukast 10 mg
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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
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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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
MK-1029 150 mg + Montelukast 10 mg
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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
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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. |
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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.
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End point type |
Primary
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End point timeframe |
Before the first dose (Baseline) and at the end of Weeks 4 and 6 of treatment
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Statistical analysis title |
Between-group comparison | ||||||||||||
Comparison groups |
MK-1029 150 mg + Montelukast 10 mg v MK-1029 Placebo + Montelukast 10 mg
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Number of subjects included in analysis |
139
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Analysis specification |
Pre-specified
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Analysis type |
[1] | ||||||||||||
P-value |
= 0.023 | ||||||||||||
Method |
Constrained longitudinal data analysis | ||||||||||||
Parameter type |
Difference in least squares means | ||||||||||||
Point estimate |
0.107
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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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. |
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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.
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End point type |
Secondary
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End point timeframe |
Up to 4 weeks
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Statistical analysis title |
Between-group comparison | ||||||||||||
Comparison groups |
MK-1029 150 mg + Montelukast 10 mg v MK-1029 Placebo + Montelukast 10 mg
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Number of subjects included in analysis |
96
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Analysis specification |
Pre-specified
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Analysis type |
[2] | ||||||||||||
P-value |
= 0.352 | ||||||||||||
Method |
ANOVA | ||||||||||||
Parameter type |
Difference in least squares means | ||||||||||||
Point estimate |
-4.775
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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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. |
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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.
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End point type |
Secondary
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End point timeframe |
Up to 8 weeks
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Statistical analysis title |
Between-group comparison | ||||||||||||
Statistical analysis description |
Based on Miettinen & Nurminen
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Comparison groups |
MK-1029 150 mg + Montelukast 10 mg v MK-1029 Placebo + Montelukast 10 mg
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Number of subjects included in analysis |
139
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Analysis specification |
Pre-specified
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Analysis type |
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Method |
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Parameter type |
Difference in percentages | ||||||||||||
Point estimate |
-0.4
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-15 | ||||||||||||
upper limit |
14.3 |
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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.
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End point type |
Secondary
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End point timeframe |
Up to 6 weeks
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Statistical analysis title |
Between-group comparison | ||||||||||||
Statistical analysis description |
Based on Miettinen & Nurminen
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Comparison groups |
MK-1029 150 mg + Montelukast 10 mg v MK-1029 Placebo + Montelukast 10 mg
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Number of subjects included in analysis |
139
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Analysis specification |
Pre-specified
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Analysis type |
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Method |
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Parameter type |
Difference in percentages | ||||||||||||
Point estimate |
-4.3
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-12.1 | ||||||||||||
upper limit |
1 |
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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.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 6
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No statistical analyses for this end point |
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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.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 6
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No statistical analyses for this end point |
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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.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 6
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No statistical analyses for this end point |
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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.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 6
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No statistical analyses for this end point |
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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 (%).
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End point type |
Secondary
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End point timeframe |
Baseline and Week 6
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No statistical analyses for this end point |
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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 (%).
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End point type |
Secondary
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End point timeframe |
Baseline and Week 6
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No statistical analyses for this end point |
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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.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 6
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No statistical analyses for this end point |
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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.
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End point type |
Secondary
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End point timeframe |
Baseline and Week 6
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No statistical analyses for this end point |
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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 (%).
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End point type |
Secondary
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End point timeframe |
Baseline and Week 6
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
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
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
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
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
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
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
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
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
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
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
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
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
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
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
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
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
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
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
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
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
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
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
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
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||
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. | ||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||
|
|
|||
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 |