A Dose-Ranging Study of MK-1029 in Adults With Persistent... | NCT01656395 | Trialant
NCT01656395
Sponsor
Merck Sharp & Dohme LLC
Status
Terminated
Last Update Posted
Sep 13, 2018Actual
Enrollment
576Actual
Phase
Phase 2
Conditions
Asthma
Interventions
MK-1029
Montelukast 10 mg
Placebo
Countries
Not provided
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT01656395
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
1029-012
Secondary IDs
ID
Type
Description
Link
2012-000643-27
EudraCT Number
132230
Registry Identifier
JAPIC-CTI
Brief Title
A Dose-Ranging Study of MK-1029 in Adults With Persistent Asthma (MK-1029-012)
Official Title
A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel-Group, Adaptive-Design, Dose-Ranging Study of MK-1029 in Adult Subjects With Persistent Asthma
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Aug 2018
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 23, 2012Actual
Primary Completion Date
Jun 10, 2014Actual
Completion Date
Jul 8, 2014Actual
First Submitted Date
Jul 3, 2012
First Submission Date that Met QC Criteria
Jul 31, 2012
First Posted Date
Aug 3, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 12, 2018
Results First Submitted that Met QC Criteria
Aug 15, 2018
Results First Posted Date
Sep 13, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Aug 15, 2018
Last Update Posted Date
Sep 13, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This adaptive design, dose-ranging study of MK-1029 will assess the dose-related efficacy and safety of MK-1029 compared with placebo using measures of lung function (forced expiratory volume in 1 second [FEV1]). The primary objectives are (1) To demonstrate that MK-1029, compared with placebo, results in dose-related improvements in FEV1 over the last 6 weeks of the 12-week active-treatment period; and (2) To determine the dose-related safety and tolerability of MK-1029 as monotherapy and as concomitant dosing with montelukast over 12 weeks. The primary hypothesis is: MK-1029 is superior to placebo in a dose-related fashion in the average change from baseline in FEV1 over the last 6 weeks of the 12-week active-treatment period.
Detailed Description
Not provided
Conditions Module
Conditions
Asthma
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
576Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
MK-1029 10 mg
Experimental
Participants receive MK-1029 10 mg tablets once daily (QD) for 12 weeks
Drug: MK-1029
MK-1029 30 mg
Experimental
Participants receive MK-1029 30 mg tablets QD for 12 weeks
Drug: MK-1029
MK-1029 60 mg
Experimental
Participants will receive MK-1029 two 30 mg tablets QD for 12 weeks
Drug: MK-1029
MK-1029 150 mg
Experimental
Participants will receive MK-1029 150 mg tablets QD for 12 weeks
Drug: MK-1029
Montelukast 10 mg
Active Comparator
Participants will receive Montelukast 10 mg tablets QD for 12 weeks
Drug: Montelukast 10 mg
Placebo
Placebo Comparator
Participants will receive Placebo tablets QD for 12 weeks
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MK-1029
Drug
MK-1029 10 mg, 30 mg or 150 mg oral tablets taken QD at bedtime, based on randomization.
MK-1029 1 mg or 3 mg
MK-1029 10 mg
MK-1029 150 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Average Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
FEV1 is the amount of air (in liters) forcibly exhaled in one second. Repeated measurements of FEV1 were collected at visits during the 12 week active treatment period and the average change from baseline in FEV1 over the last 6 weeks of the 12-week-treatment period (visits at Week 6, Week 8, Week 10 and Week 12) was estimated using a constrained longitudinal data analysis (cLDA) model. In the cLDA analysis, baseline was the average FEV1 during the placebo run-in period and the post-baseline value was the average FEV1 over Week 6 to Week 12.
Baseline and last six weeks of treatment (visits at Week 6, Week 8, Week 10 and Week 12)
Percentage of Participants Who Experience Adverse Events (AEs)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the study drug, is also an AE.
Up to 14 weeks
Percentage of Participants Who Discontinue Study Due to AEs
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the study drug, is also an AE.
Up to 14 weeks
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Asthma Exacerbation Days
An asthma exacerbation day was defined as a day with ANY of the following: a decrease from Baseline in morning (AM) Peak Expiratory Flow (PEF) of more than 20%, an AM PEF of less than 180 liters (L)/min, an increase in Short Acting Beta2 Agonist (SABA) 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%, an overnight asthma symptom of: Awake "all night", or an asthma attack. Information on asthma exacerbation days was recorded throughout the study in the participant's electronic diary (e-Diary), and an Analysis of Variance (ANOVA) was used to calculate the average percentage of days with asthma exacerbations over Week 6 to Week 12.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
not pregnant or breastfeeding, and not planning to become pregnant during the study
history of symptoms of persistent asthma for at least one year
current use of acceptable asthma treatments and willingness to taper or discontinue these treatments; acceptable asthma treatments:
use of inhaled SABAs (e.g., albuterol/salbutamol) only "as-needed" with no use of asthma controller medications; OR
use of stable doses of low- or medium-dose inhaled corticosteroids (ICS), alone, or in combination with either a long-acting beta-agonist (LABA) or other asthma controller medications (including leukotriene receptor antagonists) and can tolerate tapering or discontinuation
no history of smoking OR no smoking within <1 year with a smoking history of ≤10 pack-years
ability to maintain a constant day/night, awake/sleep cycle
agreement to not change habitual consumption of beverages or food containing caffeine throughout the study
Body Mass Index (BMI) of 15 to 40 kg/m^2
Exclusion Criteria:
myocardial infarction, congestive heart failure, or uncontrolled cardiac arrhythmia within past ≤3 months
hospitalization within past ≤4 weeks
major surgical procedure within past ≤4 weeks
participation in a clinical study involving an investigational drug within past ≤4 weeks
current regular use or recent (within past ≤5 years) past abuse of alcohol (>14 drinks/week) or illicit drugs
donation of a unit of blood within past ≤2 weeks or intention to donate a unit of blood during the study
evidence of another clinically significant, active pulmonary disorder such as chronic obstructive pulmonary disease (COPD)
emergency room treatment for asthma within past ≤4 weeks or hospitalization for asthma within past ≤8 weeks
respiratory tract infection requiring antibiotic treatment within past ≤8 weeks
evidence of active, clinically significant sinus disease within past ≤1 week
history of a clinically significant psychiatric disorder, other than stable depression, within past ≤12 weeks
history of HIV
hypersensitivity or intolerance to inhaled beta-agonists, leukotriene antagonists, leukotriene synthesis inhibitors, or any of their ingredients, including lactose and galactose
clinically unstable disease of the ophthalmologic, neurological, hepatic, renal, connective tissue, genitourinary, gastrointestinal, cardiovascular or hematologic systems
current cancer or history (within past ≤5 years) of cancer (except for successfully treated basal and squamous cell carcinomas of the skin); if cancer-free for >5 years, study participation may be allowed
Out of 576 randomized participants, 557 received treatment. The planned MK-1029 1 or 3 mg arm and the Montelukast + MK-1029 arm did not enroll any participants.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
MK-1029 10 mg
Participants receive MK-1029 10 mg tablets once daily (QD) for 12 weeks
FG001
MK-1029 30 mg
Participants receive MK-1029 30 mg tablets QD for 12 weeks
FG002
MK-1029 60 mg
Participants receive MK-1029 two 30 mg tablets QD for 12 weeks
FG003
MK-1029 150 mg
Participants receive MK-1029 150 mg tablets QD for 12 weeks
FG004
Montelukast 10 mg
Participants receive Montelukast 10 mg tablets QD for 12 weeks
FG005
Placebo
Participants receive Placebo tablets QD for 12 weeks
FG006
MK-1029 1 mg or 3 mg
Participants were to receive either MK-1029 1 mg or 3 mg tablets (dose to be determined based on results of interim analysis from Part I) QD. No participants were enrolled in this arm.
FG007
Montelukast 10 mg + MK-1029
Participants were to receive Montelukast 10 mg tablets QD and MK-1029 tablets (dose to be determined based on results of interim analysis from Part I) QD. No participants were enrolled in this arm.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG00060 subjects
FG001127 subjects
FG002142 subjects
FG00353 subjects
FG00460 subjects
FG005134 subjects
FG0060 subjects
FG0070 subjects
Treated Participants
FG00058 subjects
FG001126 subjects
FG002135 subjects
FG00352 subjects
FG004
COMPLETED
FG00043 subjects
FG00193 subjects
FG002106 subjects
FG00341 subjects
FG004
NOT COMPLETED
FG00017 subjects
FG00134 subjects
FG00236 subjects
FG00312 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG00114 subjects
FG0025 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
All Randomized Participants
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
MK-1029 10 mg
Participants receive MK-1029 10 mg tablets once daily (QD) for 12 weeks
BG001
MK-1029 30 mg
Participants receive MK-1029 30 mg tablets QD for 12 weeks
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Average Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
FEV1 is the amount of air (in liters) forcibly exhaled in one second. Repeated measurements of FEV1 were collected at visits during the 12 week active treatment period and the average change from baseline in FEV1 over the last 6 weeks of the 12-week-treatment period (visits at Week 6, Week 8, Week 10 and Week 12) was estimated using a constrained longitudinal data analysis (cLDA) model. In the cLDA analysis, baseline was the average FEV1 during the placebo run-in period and the post-baseline value was the average FEV1 over Week 6 to Week 12.
T helper cell type 2 (TH2)-High participants who received ≥1 study drug dose and had FEV1 data.
Posted
Least Squares Mean
95% Confidence Interval
Liters
Baseline and last six weeks of treatment (visits at Week 6, Week 8, Week 10 and Week 12)
ID
Title
Description
OG000
MK-1029 10 mg
Adverse Events Module
Frequency Threshold
5
Time Frame
Up to 14 weeks (Up to 2 weeks after last dose of study drug)
Description
The safety population consisted of all randomized participants who received ≥1 dose of study drug.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
MK-1029 10 mg
Participants receive MK-1029 10 mg tablets once daily (QD) for 12 weeks
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cardiac failure congestive
Cardiac disorders
MeDRA 17.0
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MeDRA 17.0
Systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
1-800-672-6372
ClinicalTrialsDisclosure@merck.com
Jul 10, 2026
Removed Countries
Belgium
Canada
Chile
Colombia
France
Germany
Guatemala
Italy
Japan
Peru
Puerto Rico
South Africa
United Kingdom
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D001249
Asthma
Ancestor Terms
ID
Term
D001982
Bronchial Diseases
D012140
Respiratory Tract Diseases
D008173
Lung Diseases, Obstructive
D008171
Lung Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
C093875
montelukast
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Drug: Placebo
MK-1029 1 mg or 3 mg
Experimental
Participants will receive either MK-1029 1 mg or 3 mg tablets (dose to be determined based on results of interim analysis from Part I) QD.
Drug: MK-1029
Montelukast 10 mg + MK-1029
Experimental
Participants will receive Montelukast 10 mg tablets QD and MK-1029 tablets (dose to be determined based on results of interim analysis from Part I) QD
Drug: Montelukast 10 mg
MK-1029 30 mg
MK-1029 60 mg
Montelukast 10 mg
Drug
Parts I-II: Participants will receive Montelukast 10 mg tablets QD
Montelukast 10 mg
Montelukast 10 mg + MK-1029
SINGULAIR®
Placebo
Drug
Parts I-II: Participants will receive Placebo tablets QD
Placebo
Week 6 to Week 12
Average Change From Baseline in Daytime Symptom Score (DSS)
The Daytime Symptom Score assessed daytime asthma symptoms. In the evening just before going to bed, participants scored their asthma symptoms for the period since arising by answering the following 4 questions in eDiaries: 1) How often did you experience asthma symptoms today?, 2) How much did your asthma symptoms bother you?, 3) How much activity could you do today? and 4) How often did your asthma affect your activities today? The 4 questions were scored on a 7-point scale (0=best to 6=worst) and averaged for a single score. The average change from baseline in DSS over the last 6 weeks of the 12-week-treatment period (visits at Week 6, Week 8, Week 10 and Week 12) was estimated using a cLDA model. In the cLDA analysis, baseline was the average DSS score during the placebo run-in period and the post-baseline value was the average DSS Score over Week 6 to Week 12.
Baseline and last six weeks of treatment (visits at Week 6, Week 8, Week 10 and Week 12)
Average Change From Baseline in Use of Short-Acting Beta-Agonists (SABAs)
Twice daily (upon arising and before going to sleep), participants recorded the total number of puff (actuations) of SABA used for asthma symptoms in their eDiaries. The number of SABA puffs used in one day was calculated based on eDiary entries as the sum of daytime and nighttime number of puffs of SABA. The average change from baseline over the last 6 weeks of the 12-week-treatment period (visits at Week 6, Week 8, Week 10 and Week 12) in the daily number of SABA puffs was estimated using a cLDA model. In the cLDA analysis, Baseline was the average number of SABA puffs used in one day during the placebo run-in period and the post-baseline value was calculated as the average number of SABA puffs used in one day over Week 6 to Week 12.
Baseline and last six weeks of treatment (visits at Week 6, Week 8, Week 10 and Week 12)
Average Change From Baseline in Number of Nocturnal Awakenings
The number of nights per week (between consecutive visits) that a participant awakened with asthma was based on eDiary entries and was calculated by dividing the number of nights a participant awakened with asthma (positive responses of once, more than once, awake "all night") by the total number of nights (all responses) and then multiplying by 7 (standardized to a 7-day period). The average change from baseline in number of nocturnal awakenings over the last 6 weeks of the 12-week-treatment period (visits at Week 6, Week 8, Week 10 and Week 12) was estimated using a cLDA model. In the cLDA analysis, baseline was the average number of nocturnal awakenings during the placebo run-in period and the post-baseline value was calculated as the average number of nocturnal awakenings over Week 6 to Week 12.
Baseline and last six weeks of treatment (visits at Week 6, Week 8, Week 10 and Week 12)
Average Change From Baseline in Morning/Evening Peak Expiratory Flow (AM/PM PEF)
PEF was defined as a person's maximum speed (rate) of expiration as measured with a peak flow meter in liters per minute. Participants performed triplicate PEF measurements twice daily using a PEF meter, in the AM upon rising and in the PM immediately before study drug administration at bedtime. All three values were recorded and the average of the best morning PEF and the best evening PEF for each day (AM/PM) was determined through the e-Diary. The average change from Baseline in AM/PM PEF over the last 6 weeks of a 12-week treatment period (visits at Week 6, Week 8, Week 10 and Week 12) was estimated using a cLDA model. In the cLDA analysis, baseline was the average AM/PM PEF value during the placebo run-in period and the post-baseline value was calculated as the average AM/PM PEF over Week 6 to Week 12.
Baseline and last six weeks of treatment (visits at Week 6, Week 8, Week 10 and Week 12)
Change From Baseline in Asthma Quality of Life Questionnaire With Standardised Activities [AQLQ(S)] Overall and Domain Scores
The AQLQ(S) is a 32-item questionnaire with questions on 4 domains (asthma symptoms, activity limitation, emotional function and environmental stimuli) over the previous 2 weeks. Responses were scored on a 7-point scale (1=worst to 7=best). Each domain score is defined as the average score of all answered questions in that domain. The AQLQ(S) Overall Score is defined as the average of all available item scores (1=worst to 7=best). The changes from baseline are presented for the overall scores and the individual domain scores. Baseline was the last measurement taken prior to the first double-blind study drug. The ending values were calculated as the average AQLQ(S) Overall Score and domain scores at Week 12 of a 12-week treatment period. Statistical analyses are provided for the AQLQ(S) Overall Scores only.
Baseline and Week 12
Percentage of Participants With a ≥0.5 Change From Baseline in AQLQ(S) Overall and Domain Scores
The AQLQ(S) is a 32-item questionnaire with questions on 4 domains (asthma symptoms, activity limitation, emotional function and environmental stimuli) over the previous 2 weeks. Responses were scored on a 7-point scale (1=worst to 7=best). Each domain score is defined as the average score of all answered questions in that domain. The AQLQ(S) Overall Score is defined as the average of all available item scores (1=worst to 7=best). The percentage of participants who experienced a ≥0.5 increase in AQLQ(S) Overall and Domain Scores at Week 12 compared to baseline was calculated using the Miettinen and Nurminen (MN) method. Statistical analyses are provide for the AQLQ(S) Overall Score response rate only.
Baseline and Week 12
Change From Baseline in Asthma Control Questionnaire (ACQ) Score
The ACQ is a validated 6-item measure of asthma control to evaluate asthma control in response to therapy. Participants evaluate their asthma over the previous week by answering 6 questions: How often were you woken by your asthma during the night? How bad were your asthma symptoms when you woke up in the morning? How limited were you in your activities because of your asthma? How much shortness of breath did you experience because of your asthma? How much of the time did you wheeze? How many puffs/inhalations of short-acting bronchodilator have you used each day? Each response to a question was scored on a 7-point scale (0=best to 6=worst). The ACQ score is the average of the scores for the 6 items. Change from baseline to Week 12 in ACQ was estimated using a cLDA model. In the cLDA analysis, the Baseline value was the last measurement taken prior to the first double-blind study drug and the post-baseline value was calculated as the average ACQ Score at Week 12.
Baseline and Week 12
Percentage of Participants With a ≥0.5 Change From Baseline in ACQ Score
The ACQ is a validated 6-item measure of asthma control to evaluate asthma control in response to therapy. Participants evaluate their asthma over the previous week by answering 6 questions: How often were you woken by your asthma during the night? How bad were your asthma symptoms when you woke up in the morning? How limited were you in your activities because of your asthma? How much shortness of breath did you experience because of your asthma? How much of the time did you wheeze? How many puffs/inhalations of short-acting bronchodilator have you used each day? Each response to a question was scored on a 7-point scale (0=best to 6=worst). The ACQ score is the average of the scores for the 6 items. The percentage of participants who experienced a ≥0.5 decrease in ACQ Score at Week 12 compared to Baseline was calculated using the MN method.
Baseline and Week 12
Percentage of Asthma Attack Days
An asthma attack was defined as asthma symptoms during the previous 24 hours requiring one or more of the following: corticosteroid use (systemic), unscheduled visit to the doctor or urgent care clinic, unscheduled visit to the emergency department or hospitalization. Information on asthma attacks was recorded throughout the study in the participant's e-Diary, and an Analysis of Variance (ANOVA) was used to calculate the average percentage of asthma attack days over Week 6 to Week 12 of a 12-week treatment period.
Week 6 to Week 12
60 subjects
FG005126 subjects
FG0060 subjects
FG0070 subjects
46 subjects
FG00594 subjects
FG0060 subjects
FG0070 subjects
14 subjects
FG00540 subjects
FG0060 subjects
FG0070 subjects
4 subjects
FG0045 subjects
FG0057 subjects
FG0060 subjects
FG0070 subjects
Lack of Efficacy
FG0001 subjects
FG0018 subjects
FG0026 subjects
FG0031 subjects
FG0041 subjects
FG0056 subjects
FG0060 subjects
FG0070 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Non-Compliance with Study Drug
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
Other
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
Physician Decision
FG0002 subjects
FG0013 subjects
FG0023 subjects
FG0032 subjects
FG0043 subjects
FG0053 subjects
FG0060 subjects
FG0070 subjects
Pregnancy
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Progressive Disease
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
Protocol Violation
FG0006 subjects
FG0016 subjects
FG0029 subjects
FG0032 subjects
FG0044 subjects
FG00510 subjects
FG0060 subjects
FG0070 subjects
Screen Failure
FG0002 subjects
FG0011 subjects
FG0027 subjects
FG0031 subjects
FG0040 subjects
FG0058 subjects
FG0060 subjects
FG0070 subjects
Withdrawal by Subject
FG0003 subjects
FG0011 subjects
FG0024 subjects
FG0032 subjects
FG0040 subjects
FG0053 subjects
FG0060 subjects
FG0070 subjects
BG002
MK-1029 60 mg
Participants receive MK-1029 two 30 mg tablets QD for 12 weeks
BG003
MK-1029 150 mg
Participants receive MK-1029 150 mg tablets QD for 12 weeks
BG004
Montelukast 10 mg
Participants receive Montelukast 10 mg tablets QD for 12 weeks
BG005
Placebo
Participants receive Placebo tablets QD for 12 weeks
BG006
Total
Total of all reporting groups
60
BG001127
BG002142
BG00353
BG00460
BG005134
BG006576
Standard Deviation
Years
Title
Denominators
Categories
ParticipantsBG00060
ParticipantsBG001127
ParticipantsBG002142
ParticipantsBG00353
ParticipantsBG00460
ParticipantsBG005134
ParticipantsBG006576
Title
Measurements
BG00039.9± 13.2
BG00144.3± 12.4
BG00243± 13.2
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00060
ParticipantsBG001127
ParticipantsBG002142
ParticipantsBG00353
ParticipantsBG00460
ParticipantsBG005134
ParticipantsBG006576
Title
Measurements
Female
BG00033
BG00178
BG00277
BG003
Asthma Phenotype
The Asthma Phenotype in this study was defined as either "Th2-High" or "Th2-Low," based on measurements of asthmatic inflammation. Th2-High was defined according to the following 2 criteria at Visit 1: a peripheral-blood absolute eosinophil count ≥ 0.30 X 10^9/liters(L), and/or a peripheral-blood absolute eosinophil count ≥0.14 X 10^9/L with serum total IgE ≥100 IU/mL. Th2-Low was operationally defined as meeting neither of these criteria.
All participants who received ≥1 dose of study drug.
Number
Participants
Title
Denominators
Categories
Th2-High
ParticipantsBG00058
ParticipantsBG001126
ParticipantsBG002135
ParticipantsBG00352
ParticipantsBG00460
ParticipantsBG005126
ParticipantsBG006557
Title
Measurements
BG00058
BG00150
BG00247
BG003
Th2-Low
ParticipantsBG00060
ParticipantsBG001127
ParticipantsBG002142
ParticipantsBG00353
Participants receive MK-1029 10 mg tablets once daily (QD) for 12 weeks
OG001
MK-1029 30 mg
Participants receive MK-1029 30 mg tablets QD for 12 weeks
OG002
MK-1029 60 mg
Participants will receive MK-1029 two 30 mg tablets QD for 12 weeks
OG003
MK-1029 150 mg
Participants will receive MK-1029 150 mg tablets QD for 12 weeks
OG004
Montelukast 10 mg
Participants will receive Montelukast 10 mg tablets QD for 12 weeks
OG005
Placebo
Participants will receive Placebo tablets QD for 12 weeks
Units
Counts
Participants
OG00057
OG00150
OG00247
OG00352
OG00460
OG00558
Title
Denominators
Categories
Title
Measurements
OG0000.065(-0.009 to 0.139)
OG0010.004(-0.075 to 0.083)
OG0020.063(-0.019 to 0.144)
OG0030.036(-0.04 to 0.112)
OG0040.039(-0.033 to 0.111)
OG0050.043(-0.032 to 0.119)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG005
Difference in least squares (LS) means for average change from Baseline over Week 6 to Week 12 in FEV1: MK-1029 10 mg vs. Placebo. Constrained longitudinal data analysis (cLDA) model includes terms for visit as categorical variable, prior inhaled corticosteroid (ICS) use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).
cLDA model
0.685
Mean Difference (Final Values)
0.022
2-Sided
95
-0.084
0.127
Superiority
OG001
OG005
Difference in LS means for average change from Baseline over Week 6 to Week 12 in FEV1: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).
cLDA model
0.477
Mean Difference (Final Values)
-0.04
2-Sided
95
-0.149
0.07
Superiority
OG002
OG005
Difference in LS means for average change from Baseline over Week 6 to Week 12 in FEV1: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).
cLDA model
0.733
Mean Difference (Final Values)
0.019
2-Sided
95
-0.092
0.13
Superiority
OG003
OG005
Difference in LS means for average change from Baseline over Week 6 to Week 12 in FEV1: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).
cLDA model
0.89
Mean Difference (Final Values)
-0.008
2-Sided
95
-0.115
0.1
Superiority
OG004
OG005
Difference in LS means for average change from Baseline over Week 6 to Week 12 in FEV1: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).
cLDA model
0.935
Mean Difference (Final Values)
-0.004
2-Sided
95
-0.109
0.1
Superiority
Primary
Percentage of Participants Who Experience Adverse Events (AEs)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the study drug, is also an AE.
All randomized participants who received ≥1 dose of study drug.
Posted
Number
Percentage of participants
Up to 14 weeks
ID
Title
Description
OG000
MK-1029 10 mg
Participants receive MK-1029 10 mg tablets once daily (QD) for 12 weeks
OG001
MK-1029 30 mg
Participants receive MK-1029 30 mg tablets QD for 12 weeks
OG002
MK-1029 60 mg
Participants will receive MK-1029 two 30 mg tablets QD for 12 weeks
OG003
MK-1029 150 mg
Participants will receive MK-1029 150 mg tablets QD for 12 weeks
OG004
Montelukast 10 mg
Participants will receive Montelukast 10 mg tablets QD for 12 weeks
OG005
Placebo
Participants will receive Placebo tablets QD for 12 weeks
Units
Counts
Participants
OG00058
OG001126
OG002135
OG003
Title
Denominators
Categories
Title
Measurements
OG00044.8
OG00148.4
OG00247.4
OG003
Primary
Percentage of Participants Who Discontinue Study Due to AEs
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the study drug, is also an AE.
All randomized participants who received ≥1 dose of study drug.
Posted
Number
Percentage of participants
Up to 14 weeks
ID
Title
Description
OG000
MK-1029 10 mg
Participants receive MK-1029 10 mg tablets once daily (QD) for 12 weeks
OG001
MK-1029 30 mg
Participants receive MK-1029 30 mg tablets QD for 12 weeks
OG002
MK-1029 60 mg
Participants will receive MK-1029 two 30 mg tablets QD for 12 weeks
OG003
MK-1029 150 mg
Participants will receive MK-1029 150 mg tablets QD for 12 weeks
OG004
Montelukast 10 mg
Participants will receive Montelukast 10 mg tablets QD for 12 weeks
OG005
Placebo
Participants will receive Placebo tablets QD for 12 weeks
Units
Counts
Participants
OG00058
OG001126
OG002135
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.7
OG00110.3
OG0023.7
OG003
Secondary
Percentage of Asthma Exacerbation Days
An asthma exacerbation day was defined as a day with ANY of the following: a decrease from Baseline in morning (AM) Peak Expiratory Flow (PEF) of more than 20%, an AM PEF of less than 180 liters (L)/min, an increase in Short Acting Beta2 Agonist (SABA) 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%, an overnight asthma symptom of: Awake "all night", or an asthma attack. Information on asthma exacerbation days was recorded throughout the study in the participant's electronic diary (e-Diary), and an Analysis of Variance (ANOVA) was used to calculate the average percentage of days with asthma exacerbations over Week 6 to Week 12.
TH2-High participants who received ≥1 study drug dose and had asthma exacerbation data.
Posted
Least Squares Mean
95% Confidence Interval
Percentage of Asthma Exacerbation Days
Week 6 to Week 12
ID
Title
Description
OG000
MK-1029 10 mg
Participants receive MK-1029 10 mg tablets once daily (QD) for 12 weeks
OG001
MK-1029 30 mg
Participants receive MK-1029 30 mg tablets QD for 12 weeks
OG002
MK-1029 60 mg
Participants will receive MK-1029 two 30 mg tablets QD for 12 weeks
OG003
MK-1029 150 mg
Participants will receive MK-1029 150 mg tablets QD for 12 weeks
OG004
Montelukast 10 mg
Participants will receive Montelukast 10 mg tablets QD for 12 weeks
OG005
Placebo
Participants will receive Placebo tablets QD for 12 weeks
Units
Counts
Participants
OG00044
OG00139
OG00237
OG003
Title
Denominators
Categories
Title
Measurements
OG00017.704(10.657 to 24.75)
OG00115.812(8.334 to 23.29)
OG00215.435(7.752 to 23.118)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG005
Difference in LS means for percent of asthma exacerbation day over Week 6 through Week 12: MK- 1029 10 mg vs. Placebo. Analysis of variance (ANOVA) model includes the terms for treatment groups and prior ICS use (Yes/No). Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).
ANOVA
0.169
Mean Difference (Final Values)
-7.2
2-Sided
95
-17.48
3.08
Superiority
Secondary
Average Change From Baseline in Daytime Symptom Score (DSS)
The Daytime Symptom Score assessed daytime asthma symptoms. In the evening just before going to bed, participants scored their asthma symptoms for the period since arising by answering the following 4 questions in eDiaries: 1) How often did you experience asthma symptoms today?, 2) How much did your asthma symptoms bother you?, 3) How much activity could you do today? and 4) How often did your asthma affect your activities today? The 4 questions were scored on a 7-point scale (0=best to 6=worst) and averaged for a single score. The average change from baseline in DSS over the last 6 weeks of the 12-week-treatment period (visits at Week 6, Week 8, Week 10 and Week 12) was estimated using a cLDA model. In the cLDA analysis, baseline was the average DSS score during the placebo run-in period and the post-baseline value was the average DSS Score over Week 6 to Week 12.
TH2-High participants who received ≥1 study drug dose and had DSS data.
Posted
Least Squares Mean
95% Confidence Interval
Score on a scale
Baseline and last six weeks of treatment (visits at Week 6, Week 8, Week 10 and Week 12)
ID
Title
Description
OG000
MK-1029 10 mg
Participants receive MK-1029 10 mg tablets once daily (QD) for 12 weeks
OG001
MK-1029 30 mg
Participants receive MK-1029 30 mg tablets QD for 12 weeks
OG002
MK-1029 60 mg
Participants will receive MK-1029 two 30 mg tablets QD for 12 weeks
OG003
MK-1029 150 mg
Participants will receive MK-1029 150 mg tablets QD for 12 weeks
OG004
Montelukast 10 mg
Participants will receive Montelukast 10 mg tablets QD for 12 weeks
OG005
Placebo
Participants will receive Placebo tablets QD for 12 weeks
Units
Counts
Participants
OG00045
OG00141
OG00240
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.398(-0.612 to -0.184)
OG001-0.134(-0.358 to 0.091)
OG002-0.364(-0.591 to -0.137)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG005
Difference in LS means for average change from Baseline to Week 12 in DSS: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).
cLDA model
0.429
Mean Difference (Final Values)
-0.122
2-Sided
95
-0.427
0.182
Superiority
Secondary
Average Change From Baseline in Use of Short-Acting Beta-Agonists (SABAs)
Twice daily (upon arising and before going to sleep), participants recorded the total number of puff (actuations) of SABA used for asthma symptoms in their eDiaries. The number of SABA puffs used in one day was calculated based on eDiary entries as the sum of daytime and nighttime number of puffs of SABA. The average change from baseline over the last 6 weeks of the 12-week-treatment period (visits at Week 6, Week 8, Week 10 and Week 12) in the daily number of SABA puffs was estimated using a cLDA model. In the cLDA analysis, Baseline was the average number of SABA puffs used in one day during the placebo run-in period and the post-baseline value was calculated as the average number of SABA puffs used in one day over Week 6 to Week 12.
TH2-High participants who received ≥1 study drug dose and had SABA usage data.
Posted
Least Squares Mean
95% Confidence Interval
Number of SABA Puffs
Baseline and last six weeks of treatment (visits at Week 6, Week 8, Week 10 and Week 12)
ID
Title
Description
OG000
MK-1029 10 mg
Participants receive MK-1029 10 mg tablets once daily (QD) for 12 weeks
OG001
MK-1029 30 mg
Participants receive MK-1029 30 mg tablets QD for 12 weeks
OG002
MK-1029 60 mg
Participants will receive MK-1029 two 30 mg tablets QD for 12 weeks
OG003
MK-1029 150 mg
Participants will receive MK-1029 150 mg tablets QD for 12 weeks
OG004
Montelukast 10 mg
Participants will receive Montelukast 10 mg tablets QD for 12 weeks
OG005
Placebo
Participants will receive Placebo tablets QD for 12 weeks
Units
Counts
Participants
OG00046
OG00141
OG00240
OG003
Title
Denominators
Categories
Title
Measurements
OG000-1.373(-1.847 to -0.899)
OG001-0.920(-1.420 to -0.421)
OG002-0.955(-1.461 to -0.450)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG005
Difference in LS means for average change from Baseline over Week 6 to Week 12 in SABA use: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use(Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).
cLDA model
0.114
Mean Difference (Final Values)
-0.528
2-Sided
95
-1.184
0.128
Superiority
Secondary
Average Change From Baseline in Number of Nocturnal Awakenings
The number of nights per week (between consecutive visits) that a participant awakened with asthma was based on eDiary entries and was calculated by dividing the number of nights a participant awakened with asthma (positive responses of once, more than once, awake "all night") by the total number of nights (all responses) and then multiplying by 7 (standardized to a 7-day period). The average change from baseline in number of nocturnal awakenings over the last 6 weeks of the 12-week-treatment period (visits at Week 6, Week 8, Week 10 and Week 12) was estimated using a cLDA model. In the cLDA analysis, baseline was the average number of nocturnal awakenings during the placebo run-in period and the post-baseline value was calculated as the average number of nocturnal awakenings over Week 6 to Week 12.
TH2-High participants who received ≥1 study drug dose and had nocturnal awakening data.
Posted
Least Squares Mean
95% Confidence Interval
Number of awakenings
Baseline and last six weeks of treatment (visits at Week 6, Week 8, Week 10 and Week 12)
ID
Title
Description
OG000
MK-1029 10 mg
Participants receive MK-1029 10 mg tablets once daily (QD) for 12 weeks
OG001
MK-1029 30 mg
Participants receive MK-1029 30 mg tablets QD for 12 weeks
OG002
MK-1029 60 mg
Participants will receive MK-1029 two 30 mg tablets QD for 12 weeks
OG003
MK-1029 150 mg
Participants will receive MK-1029 150 mg tablets QD for 12 weeks
OG004
Montelukast 10 mg
Participants will receive Montelukast 10 mg tablets QD for 12 weeks
OG005
Placebo
Participants will receive Placebo tablets QD for 12 weeks
Units
Counts
Participants
OG00046
OG00141
OG00240
OG003
Title
Denominators
Categories
Title
Measurements
OG000-1.277(-1.861 to -0.692)
OG001-0.900(-1.518 to -0.282)
OG002-1.286(-1.912 to -0.661)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG005
Difference in LS means for average change from Baseline over Week 6 to Week 12 in nocturnal awakenings: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).
cLDA model
0.565
Mean Difference (Final Values)
-0.241
2-Sided
95
-1.066
0.583
Superiority
Secondary
Average Change From Baseline in Morning/Evening Peak Expiratory Flow (AM/PM PEF)
PEF was defined as a person's maximum speed (rate) of expiration as measured with a peak flow meter in liters per minute. Participants performed triplicate PEF measurements twice daily using a PEF meter, in the AM upon rising and in the PM immediately before study drug administration at bedtime. All three values were recorded and the average of the best morning PEF and the best evening PEF for each day (AM/PM) was determined through the e-Diary. The average change from Baseline in AM/PM PEF over the last 6 weeks of a 12-week treatment period (visits at Week 6, Week 8, Week 10 and Week 12) was estimated using a cLDA model. In the cLDA analysis, baseline was the average AM/PM PEF value during the placebo run-in period and the post-baseline value was calculated as the average AM/PM PEF over Week 6 to Week 12.
TH2-High participants who received ≥1 study drug dose and had AM/PM PEF data.
Posted
Least Squares Mean
95% Confidence Interval
Liters/minutes
Baseline and last six weeks of treatment (visits at Week 6, Week 8, Week 10 and Week 12)
ID
Title
Description
OG000
MK-1029 10 mg
Participants receive MK-1029 10 mg tablets once daily (QD) for 12 weeks
OG001
MK-1029 30 mg
Participants receive MK-1029 30 mg tablets QD for 12 weeks
OG002
MK-1029 60 mg
Participants will receive MK-1029 two 30 mg tablets QD for 12 weeks
OG003
MK-1029 150 mg
Participants will receive MK-1029 150 mg tablets QD for 12 weeks
OG004
Montelukast 10 mg
Participants will receive Montelukast 10 mg tablets QD for 12 weeks
OG005
Placebo
Participants will receive Placebo tablets QD for 12 weeks
Units
Counts
Participants
OG00046
OG00141
OG00240
OG003
Title
Denominators
Categories
Title
Measurements
OG000-1.857(-16.13 to 12.413)
OG0013.850(-11.26 to 18.960)
OG0027.174(-8.124 to 22.472)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG005
Difference in LS means for average change from Baseline over Week 6 to Week 12 in AM/PM PEF: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).
cLDA model
0.958
Mean Difference (Final Values)
0.544
2-Sided
95
-19.92
21.007
Superiority
Secondary
Change From Baseline in Asthma Quality of Life Questionnaire With Standardised Activities [AQLQ(S)] Overall and Domain Scores
The AQLQ(S) is a 32-item questionnaire with questions on 4 domains (asthma symptoms, activity limitation, emotional function and environmental stimuli) over the previous 2 weeks. Responses were scored on a 7-point scale (1=worst to 7=best). Each domain score is defined as the average score of all answered questions in that domain. The AQLQ(S) Overall Score is defined as the average of all available item scores (1=worst to 7=best). The changes from baseline are presented for the overall scores and the individual domain scores. Baseline was the last measurement taken prior to the first double-blind study drug. The ending values were calculated as the average AQLQ(S) Overall Score and domain scores at Week 12 of a 12-week treatment period. Statistical analyses are provided for the AQLQ(S) Overall Scores only.
TH2-High participants who received ≥1 study drug dose and had AQLQ(S) data.
Posted
Mean
Standard Deviation
Score on a scale
Baseline and Week 12
ID
Title
Description
OG000
MK-1029 10 mg
Participants receive MK-1029 10 mg tablets once daily (QD) for 12 weeks
OG001
MK-1029 30 mg
Participants receive MK-1029 30 mg tablets QD for 12 weeks
OG002
MK-1029 60 mg
Participants will receive MK-1029 two 30 mg tablets QD for 12 weeks
OG003
MK-1029 150 mg
Participants will receive MK-1029 150 mg tablets QD for 12 weeks
OG004
Montelukast 10 mg
Participants will receive Montelukast 10 mg tablets QD for 12 weeks
OG005
Placebo
Participants will receive Placebo tablets QD for 12 weeks
Units
Counts
Participants
OG00053
OG00147
OG00242
OG003
Title
Denominators
Categories
Overall Score
ParticipantsOG00053
ParticipantsOG00147
ParticipantsOG00242
ParticipantsOG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG005
Difference in LS means for change from Baseline to Week 12 in AQLQ(S) Overall Score: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).
cLDA model
0.682
Mean Difference (Final Values)
0.076
2-Sided
95
-0.288
0.440
Superiority
Secondary
Percentage of Participants With a ≥0.5 Change From Baseline in AQLQ(S) Overall and Domain Scores
The AQLQ(S) is a 32-item questionnaire with questions on 4 domains (asthma symptoms, activity limitation, emotional function and environmental stimuli) over the previous 2 weeks. Responses were scored on a 7-point scale (1=worst to 7=best). Each domain score is defined as the average score of all answered questions in that domain. The AQLQ(S) Overall Score is defined as the average of all available item scores (1=worst to 7=best). The percentage of participants who experienced a ≥0.5 increase in AQLQ(S) Overall and Domain Scores at Week 12 compared to baseline was calculated using the Miettinen and Nurminen (MN) method. Statistical analyses are provide for the AQLQ(S) Overall Score response rate only.
TH2-High participants who received ≥1 study drug dose and had AQLQ(S) data at Week 12.
Posted
Number
Percentage of participants
Baseline and Week 12
ID
Title
Description
OG000
MK-1029 10 mg
Participants receive MK-1029 10 mg tablets once daily (QD) for 12 weeks
OG001
MK-1029 30 mg
Participants receive MK-1029 30 mg tablets QD for 12 weeks
OG002
MK-1029 60 mg
Participants will receive MK-1029 two 30 mg tablets QD for 12 weeks
OG003
MK-1029 150 mg
Participants will receive MK-1029 150 mg tablets QD for 12 weeks
OG004
Montelukast 10 mg
Participants will receive Montelukast 10 mg tablets QD for 12 weeks
OG005
Placebo
Participants will receive Placebo tablets QD for 12 weeks
Units
Counts
Participants
OG00053
OG00147
OG00242
OG003
Title
Denominators
Categories
Overall Score
Title
Measurements
OG00048.99
OG00140.49
OG00257.22
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG005
Difference for AQLQ(S) Response Rate: MK-1029 10 mg vs. Placebo. P-values, estimates and 95% confidence intervals (CIs) are based on the Miettinen and Nurminen (MN) method stratified by prior ICS use (Yes/No).
MN method
0.7687
Mean Difference (Final Values)
2.8
2-Sided
95
-16.0
21.3
Superiority
OG001
OG005
Secondary
Change From Baseline in Asthma Control Questionnaire (ACQ) Score
The ACQ is a validated 6-item measure of asthma control to evaluate asthma control in response to therapy. Participants evaluate their asthma over the previous week by answering 6 questions: How often were you woken by your asthma during the night? How bad were your asthma symptoms when you woke up in the morning? How limited were you in your activities because of your asthma? How much shortness of breath did you experience because of your asthma? How much of the time did you wheeze? How many puffs/inhalations of short-acting bronchodilator have you used each day? Each response to a question was scored on a 7-point scale (0=best to 6=worst). The ACQ score is the average of the scores for the 6 items. Change from baseline to Week 12 in ACQ was estimated using a cLDA model. In the cLDA analysis, the Baseline value was the last measurement taken prior to the first double-blind study drug and the post-baseline value was calculated as the average ACQ Score at Week 12.
TH2-High participants who received ≥1 study drug dose and had ACQ data.
Posted
Least Squares Mean
95% Confidence Interval
Score on a scale
Baseline and Week 12
ID
Title
Description
OG000
MK-1029 10 mg
Participants receive MK-1029 10 mg tablets once daily (QD) for 12 weeks
OG001
MK-1029 30 mg
Participants receive MK-1029 30 mg tablets QD for 12 weeks
OG002
MK-1029 60 mg
Participants will receive MK-1029 two 30 mg tablets QD for 12 weeks
OG003
MK-1029 150 mg
Participants will receive MK-1029 150 mg tablets QD for 12 weeks
OG004
Montelukast 10 mg
Participants will receive Montelukast 10 mg tablets QD for 12 weeks
OG005
Placebo
Participants will receive Placebo tablets QD for 12 weeks
Units
Counts
Participants
OG00053
OG00147
OG00242
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.807(-1.088 to -0.527)
OG001-0.736(-1.033 to -0.438)
OG002-0.855(-1.170 to -0.541)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG005
Difference in LS means for change from Baseline to Week 12 in ACQ Score: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).
cLDA model
0.603
Mean Difference (Final Values)
-0.104
2-Sided
95
-0.495
0.288
Superiority
Secondary
Percentage of Participants With a ≥0.5 Change From Baseline in ACQ Score
The ACQ is a validated 6-item measure of asthma control to evaluate asthma control in response to therapy. Participants evaluate their asthma over the previous week by answering 6 questions: How often were you woken by your asthma during the night? How bad were your asthma symptoms when you woke up in the morning? How limited were you in your activities because of your asthma? How much shortness of breath did you experience because of your asthma? How much of the time did you wheeze? How many puffs/inhalations of short-acting bronchodilator have you used each day? Each response to a question was scored on a 7-point scale (0=best to 6=worst). The ACQ score is the average of the scores for the 6 items. The percentage of participants who experienced a ≥0.5 decrease in ACQ Score at Week 12 compared to Baseline was calculated using the MN method.
TH2-High participants who received ≥1 study drug dose and had ACQ data at Week 12.
Posted
Number
Percentage of participants
Baseline and Week 12
ID
Title
Description
OG000
MK-1029 10 mg
Participants receive MK-1029 10 mg tablets once daily (QD) for 12 weeks
OG001
MK-1029 30 mg
Participants receive MK-1029 30 mg tablets QD for 12 weeks
OG002
MK-1029 60 mg
Participants will receive MK-1029 two 30 mg tablets QD for 12 weeks
OG003
MK-1029 150 mg
Participants will receive MK-1029 150 mg tablets QD for 12 weeks
OG004
Montelukast 10 mg
Participants will receive Montelukast 10 mg tablets QD for 12 weeks
OG005
Placebo
Participants will receive Placebo tablets QD for 12 weeks
Units
Counts
Participants
OG00053
OG00147
OG00242
OG003
Title
Denominators
Categories
Title
Measurements
OG00065.51
OG00159.57
OG00266.60
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG005
Difference for change from Baseline to Week 12 in ACQ response rate: MK-1029 10 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).
MN method
0.742
Mean Difference (Final Values)
3.1
2-Sided
95
-15.1
21.1
Superiority
OG001
OG005
Secondary
Percentage of Asthma Attack Days
An asthma attack was defined as asthma symptoms during the previous 24 hours requiring one or more of the following: corticosteroid use (systemic), unscheduled visit to the doctor or urgent care clinic, unscheduled visit to the emergency department or hospitalization. Information on asthma attacks was recorded throughout the study in the participant's e-Diary, and an Analysis of Variance (ANOVA) was used to calculate the average percentage of asthma attack days over Week 6 to Week 12 of a 12-week treatment period.
TH2-High participants who received ≥1 study drug dose and had asthma attack data.
Posted
Least Squares Mean
95% Confidence Interval
Percentage
Week 6 to Week 12
ID
Title
Description
OG000
MK-1029 10 mg
Participants receive MK-1029 10 mg tablets once daily (QD) for 12 weeks
OG001
MK-1029 30 mg
Participants receive MK-1029 30 mg tablets QD for 12 weeks
OG002
MK-1029 60 mg
Participants will receive MK-1029 two 30 mg tablets QD for 12 weeks
OG003
MK-1029 150 mg
Participants will receive MK-1029 150 mg tablets QD for 12 weeks
OG004
Montelukast 10 mg
Participants will receive Montelukast 10 mg tablets QD for 12 weeks
OG005
Placebo
Participants will receive Placebo tablets QD for 12 weeks
Units
Counts
Participants
OG00043
OG00139
OG00237
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.482(-0.159 to 1.122)
OG0010.182(-0.49 to 0.854)
OG0020.017(-0.673 to 0.708)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG005
Difference in LS means for percent of asthma attack days over Week 6 to Week 12 of a 12-week treatment period: MK-1209 10 mg vs. Placebo. ANOVA model includes terms for prior ICS use (Yes/No) and treatment. Negative differences are in favor of the first treatment group in the comparison (MK- 1029 or Montelukast).
ANOVA
0.873
Mean Difference (Final Values)
-0.075
2-Sided
95
-1.004
0.853
Superiority
0
58
0
58
15
58
EG001
MK-1029 30 mg
Participants receive MK-1029 30 mg tablets QD for 12 weeks
0
126
2
126
24
126
EG002
MK-1029 60 mg
Participants receive MK-1029 two 30 mg tablets QD for 12 weeks
0
135
2
135
27
135
EG003
MK-1029 150 mg
Participants receive MK-1029 150 mg tablets QD for 12 weeks
0
52
1
52
19
52
EG004
Montelukast 10 mg
Participants receive Montelukast 10 mg tablets QD for 12 weeks
0
60
0
60
19
60
EG005
Placebo
Participants receive Placebo tablets QD for 12 weeks
0
126
1
126
42
126
EG0000 events0 affected58 at risk
EG0010 events0 affected126 at risk
EG0021 events1 affected135 at risk
EG0030 events0 affected52 at risk
EG0040 events0 affected60 at risk
EG0050 events0 affected126 at risk
Kaposi's varicelliform eruption
Infections and infestations
MeDRA 17.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0011 events1 affected126 at risk
EG0020 events0 affected135 at risk
EG0030 events0 affected52 at risk
EG0040 events0 affected60 at risk
EG0050 events0 affected126 at risk
Pneumonia
Infections and infestations
MeDRA 17.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected126 at risk
EG0021 events1 affected135 at risk
EG0030 events0 affected52 at risk
EG0040 events0 affected60 at risk
EG0050 events0 affected126 at risk
Hyperglycaemia
Metabolism and nutrition disorders
MeDRA 17.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected126 at risk
EG0020 events0 affected135 at risk
EG0031 events1 affected52 at risk
EG0040 events0 affected60 at risk
EG0050 events0 affected126 at risk
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MeDRA 17.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0011 events1 affected126 at risk
EG0020 events0 affected135 at risk
EG0030 events0 affected52 at risk
EG0040 events0 affected60 at risk
EG0050 events0 affected126 at risk
Tension headache
Nervous system disorders
MeDRA 17.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected126 at risk
EG0020 events0 affected135 at risk
EG0030 events0 affected52 at risk
EG0040 events0 affected60 at risk
EG0051 events1 affected126 at risk
Asthma
Respiratory, thoracic and mediastinal disorders
MeDRA 17.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0011 events1 affected126 at risk
EG0020 events0 affected135 at risk
EG0030 events0 affected52 at risk
EG0040 events0 affected60 at risk
EG0050 events0 affected126 at risk
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MeDRA 17.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected126 at risk
EG0021 events1 affected135 at risk
EG0030 events0 affected52 at risk
EG0040 events0 affected60 at risk
EG0050 events0 affected126 at risk
EG0000 events0 affected58 at risk
EG0014 events4 affected126 at risk
EG0022 events2 affected135 at risk
EG0033 events3 affected52 at risk
EG0040 events0 affected60 at risk
EG0053 events3 affected126 at risk
Bronchitis
Infections and infestations
MeDRA 17.0
Systematic Assessment
EG0001 events1 affected58 at risk
EG0012 events2 affected126 at risk
EG0022 events2 affected135 at risk
EG0033 events3 affected52 at risk
EG0041 events1 affected60 at risk
EG0053 events3 affected126 at risk
Cystitis
Infections and infestations
MeDRA 17.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0011 events1 affected126 at risk
EG0022 events2 affected135 at risk
EG0033 events3 affected52 at risk
EG0040 events0 affected60 at risk
EG0052 events2 affected126 at risk
Gastroenteritis
Infections and infestations
MeDRA 17.0
Systematic Assessment
EG0003 events3 affected58 at risk
EG0010 events0 affected126 at risk
EG0021 events1 affected135 at risk
EG0032 events2 affected52 at risk
EG0040 events0 affected60 at risk
EG0052 events2 affected126 at risk
Nasopharyngitis
Infections and infestations
MeDRA 17.0
Systematic Assessment
EG0004 events4 affected58 at risk
EG0016 events6 affected126 at risk
EG00210 events10 affected135 at risk
EG0037 events7 affected52 at risk
EG0045 events5 affected60 at risk
EG00512 events12 affected126 at risk
Accidental overdose
Injury, poisoning and procedural complications
MeDRA 17.0
Systematic Assessment
EG0004 events4 affected58 at risk
EG0012 events2 affected126 at risk
EG00210 events7 affected135 at risk
EG0031 events1 affected52 at risk
EG0043 events2 affected60 at risk
EG0056 events6 affected126 at risk
Asthma
Respiratory, thoracic and mediastinal disorders
MeDRA 17.0
Systematic Assessment
EG0005 events4 affected58 at risk
EG00119 events15 affected126 at risk
EG0025 events5 affected135 at risk
EG0038 events8 affected52 at risk
EG00412 events11 affected60 at risk
EG00519 events17 affected126 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication timelines.
D012130
Respiratory Hypersensitivity
D006969
Hypersensitivity, Immediate
D006967
Hypersensitivity
D007154
Immune System Diseases
41.7
± 12.2
BG00443.7± 13.3
BG00541.1± 12.4
BG00642.5± 12.8
31
BG00432
BG00547
BG006298
Male
BG00027
BG00149
BG00265
BG00322
BG00428
BG00587
BG006278
52
BG00460
BG00558
BG006325
Participants
BG004
60
ParticipantsBG005134
ParticipantsBG006576
Title
Measurements
BG0000
BG00176
BG00288
BG0030
BG0040
BG00568
BG006232
52
OG00460
OG005126
53.8
OG00456.7
OG00557.9
52
OG00460
OG005126
7.7
OG0048.3
OG0055.6
46
OG00447
OG00539
20.238
(13.353 to 27.124)
OG00419.657(12.845 to 26.47)
OG00524.904(17.424 to 32.384)
OG001
OG005
Difference in LS means for percent of asthma exacerbation day over Week 6 through Week 12: MK- 1029 30 mg vs. Placebo. ANOVA model includes the terms for treatment groups and prior ICS use (Yes/No). Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).
ANOVA
0.092
Mean Difference (Final Values)
-9.092
2-Sided
95
-19.67
1.485
Superiority
OG002
OG005
Difference in LS means for percent of asthma exacerbation day over Week 6 through Week 12: MK- 1029 60 mg vs. Placebo. ANOVA model includes the terms for treatment groups and prior ICS use (Yes/No). Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).
ANOVA
0.083
Mean Difference (Final Values)
-9.469
2-Sided
95
-20.19
1.25
Superiority
OG003
OG005
Difference in LS means for percent of asthma exacerbation day over Week 6 through Week 12: MK- 1029 150 mg vs. Placebo. ANOVA model includes the terms for treatment groups and prior ICS use (Yes/No). Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).
ANOVA
0.367
Mean Difference (Final Values)
-4.666
2-Sided
95
-14.83
5.501
Superiority
OG004
OG005
Difference in LS means for percent of asthma exacerbation day over Week 6 through Week 12: Montelukast vs. Placebo. ANOVA model includes the terms for treatment groups and prior ICS use (Yes/No). Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).
ANOVA
0.308
Mean Difference (Final Values)
-5.247
2-Sided
95
-15.36
4.871
Superiority
49
OG00449
OG00543
-0.120
(-0.325 to 0.086)
OG004-0.411(-0.617 to -0.206)
OG005-0.276(-0.495 to -0.056)
OG001
OG005
Difference in LS means for average change from Baseline to Week 12 in DSS: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).
cLDA model
0.370
Mean Difference (Final Values)
0.142
2-Sided
95
-0.169
0.454
Superiority
OG002
OG005
Difference in LS means for average change from Baseline to Week 12 in DSS: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK- 1029 or Montelukast).
cLDA model
0.579
Mean Difference (Final Values)
-0.089
2-Sided
95
-0.402
0.225
Superiority
OG003
OG005
Difference in LS means for average change from Baseline to Week 12 in DSS: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).
cLDA model
0.305
Mean Difference (Final Values)
0.156
2-Sided
95
-0.142
0.454
Superiority
OG004
OG005
Difference in LS means for average change from Baseline to Week 12 in DSS: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).
cLDA model
0.372
Mean Difference (Final Values)
-0.136
2-Sided
95
-0.434
0.163
Superiority
49
OG00449
OG00543
-0.571
(-1.031 to -0.111)
OG004-1.234(-1.694 to -0.774)
OG005-0.845(-1.334 to -0.356)
OG001
OG005
Difference in LS means for average change from Baseline over Week 6 to Week 12 in SABA use: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).
cLDA model
0.827
Mean Difference (Final Values)
-0.075
2-Sided
95
-0.75
0.6
Superiority
OG002
OG005
Difference in LS means for average change from Baseline over Week 6 to Week 12 in SABA use: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).
cLDA model
0.75
Mean Difference (Final Values)
-0.11
2-Sided
95
-0.789
0.569
Superiority
OG003
OG005
Difference in LS means for average change from Baseline over Week 6 to Week 12 in SABA use: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).
cLDA model
0.403
Mean Difference (Final Values)
0.275
2-Sided
95
-0.371
0.921
Superiority
OG004
OG005
Difference in LS means for average change from Baseline over Week 6 to Week 12 in SABA use: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).
cLDA model
0.237
Mean Difference (Final Values)
-0.389
2-Sided
95
-1.035
0.257
Superiority
49
OG00449
OG00543
-1.277
(-1.844 to -0.710)
OG004-1.107(-1.674 to -0.540)
OG005-1.036(-1.639 to -0.432)
OG001
OG005
Difference in LS means for average change from Baseline over Week 6 to Week 12 in nocturnal awakenings: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).
cLDA model
0.754
Mean Difference (Final Values)
0.135
2-Sided
95
-0.713
0.983
Superiority
OG002
OG005
Difference in LS means for average change from Baseline over Week 6 to Week 12 in nocturnal awakenings: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).
cLDA model
0.563
cLDA model
-0.251
2-Sided
95
-1.104
0.603
Superiority
OG003
OG005
Difference in LS means for average change from Baseline over Week 6 to Week 12 in nocturnal awakenings: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).
cLDA model
0.559
Mean Difference (Final Values)
-0.241
2-Sided
95
-1.053
0.571
Superiority
OG004
OG005
Difference in LS means for average change from Baseline over Week 6 to Week 12 in nocturnal awakenings: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).
cLDA model
0.863
Mean Difference (Final Values)
-0.071
2-Sided
95
-0.883
0.741
Superiority
49
OG00449
OG00543
2.713
(-11.12 to 16.543)
OG004-4.005(-17.83 to 9.825)
OG005-2.401(-17.16 to 12.357)
OG001
OG005
Difference in LS means for average change from Baseline over Week 6 to Week 12 in AM/PM PEF: MK- 1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).
cLDA model
0.559
Mean Difference (Final Values)
6.251
2-Sided
95
-14.81
27.307
Superiority
OG002
OG005
Difference in LS means for average change from Baseline over Week 6 to Week 12 in AM/PM PEF: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).
cLDA model
0.374
Median Difference (Final Values)
9.575
2-Sided
95
-11.62
30.766
Superiority
OG003
OG005
Difference in LS means for average change from Baseline over Week 6 to Week 12 in AM/PM PEF: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).
cLDA model
0.618
Mean Difference (Final Values)
5.114
2-Sided
95
-15.04
25.272
Superiority
OG004
OG005
Difference in LS means for average change from Baseline over Week 6 to Week 12 in AM/PM PEF: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).
cLDA model
0.876
Mean Difference (Final Values)
-1.604
2-Sided
95
-21.76
18.554
Superiority
47
OG00453
OG00554
47
ParticipantsOG00453
ParticipantsOG00554
Title
Measurements
OG0000.533± 1.007
OG0010.256± 0.997
OG0020.696± 1.040
OG0030.999± 1.255
OG0040.736± 1.028
OG0050.458± 1.176
Activity Domain
ParticipantsOG00053
ParticipantsOG00147
ParticipantsOG00242
ParticipantsOG00345
ParticipantsOG00452
ParticipantsOG00553
Title
Measurements
OG0000.46± 1.05
OG0010.27± 0.98
OG0020.62± 1.08
OG003
Symptoms Domain
ParticipantsOG00053
ParticipantsOG00147
ParticipantsOG00242
ParticipantsOG00345
ParticipantsOG00452
ParticipantsOG00553
Title
Measurements
OG0000.59± 1.20
OG0010.34± 1.24
OG0020.80± 1.12
OG003
Emotional Function Domain
ParticipantsOG00053
ParticipantsOG00147
ParticipantsOG00242
ParticipantsOG00345
ParticipantsOG00452
ParticipantsOG00553
Title
Measurements
OG0000.55± 1.35
OG0010.06± 1.17
OG0020.75± 1.26
OG003
Environmental Stimuli Domain
ParticipantsOG00053
ParticipantsOG00147
ParticipantsOG00242
ParticipantsOG00345
ParticipantsOG00452
ParticipantsOG00553
Title
Measurements
OG0000.53± 1.19
OG0010.21± 0.90
OG0020.54± 1.20
OG003
OG001
OG005
Difference in LS means for change from Baseline to Week 12 in AQLQ(S) Overall Score: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).
cLDA model
0.807
Mean Difference (Final Values)
-0.047
2-Sided
95
-0.422
0.329
Superiority
OG002
OG005
Difference in LS means for change from Baseline to Week 12 in AQLQ(S) Overall Score: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).
cLDA model
0.403
Mean Difference (Final Values)
0.165
2-Sided
95
-0.222
0.552
Superiority
OG003
OG005
Difference in LS means for change from Baseline to Week 12 in AQLQ(S) Overall Score: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).
cLDA model
0.051
Mean Difference (Final Values)
0.375
2-Sided
95
-0.001
0.751
Superiority
OG004
OG005
Difference in LS means for change from Baseline to Week 12 in AQLQ(S) Overall Score: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK- 1029 or Montelukast).
cLDA model
0.086
Mean Difference (Final Values)
0.319
2-Sided
95
-0.045
0.683
Superiority
45
OG00452
OG00553
64.48
OG00464.08
OG00546.14
Activity Domain
Title
Measurements
OG00047.19
OG00140.46
OG00250.00
OG00360.07
OG00452.36
OG00542.61
Symptoms Domain
Title
Measurements
OG00052.59
OG00142.63
OG00259.66
OG00357.76
OG00464.08
OG00548.13
Emotional Function Domain
Title
Measurements
OG00056.19
OG00131.95
OG00262.10
OG00357.76
OG00453.91
OG00549.90
Environmental Stimuli Domain
Title
Measurements
OG00041.79
OG00142.60
OG00259.66
OG00359.97
OG00453.16
OG00548.13
Difference for AQLQ(S) Response Rate: MK-1029 30 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).
MN Method
0.4943
Mean Difference (Final Values)
-6.6
2-Sided
95
-24.9
12.2
Superiority
OG002
OG005
Difference for AQLQ(S) Response Rate: MK-1029 60 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).
MN method
0.3003
Mean Difference (Final Values)
10.5
2-Sided
95
-9.4
29.6
Superiority
OG003
OG005
Difference for AQLQ(S) Response Rate: MK-1029 150 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).
MN method
0.0774
Mean Difference (Final Values)
17.5
2-Sided
95
-1.9
35.7
Superiority
OG004
OG005
Difference for AQLQ(S) Response Rate: Montelukast vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).
MN method
0.0555
Mean Difference (Final Values)
18.2
2-Sided
95
-0.4
35.5
Superiority
47
OG00452
OG00554
-1.066
(-1.364 to -0.768)
OG004-0.931(-1.215 to -0.648)
OG005-0.704(-0.982 to -0.426)
OG001
OG005
Difference in LS means for change from Baseline to Week 12 in ACQ Score: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).
cLDA model
0.875
Mean Difference (Final Values)
-0.032
2-Sided
95
-0.436
0.372
Superiority
OG002
OG005
Difference in LS means for change from Baseline to Week 12 in ACQ Score: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).
cLDA model
0.476
Mean Difference (Final Values)
-0.151
2-Sided
95
-0.568
0.265
Superiority
OG003
OG005
Difference in LS means for change from Baseline to Week 12 in ACQ Score: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).
cLDA model
0.079
Mean Difference (Final Values)
-0.362
2-Sided
95
-0.767
0.042
Superiority
OG004
OG005
Difference in LS means for change from Baseline to Week 12 in ACQ Score: Montelukast vs. Placebo.
cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).
cLDA model
0.257
Mean Difference (Final Values)
-0.227
2-Sided
95
-0.621
0.166
Superiority
45
OG00451
OG00554
71.11
OG00464.72
OG00562.43
Difference for change from Baseline to Week 12 in ACQ response rate: MK-1029 30 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).
MN method
0.7248
Mean Difference (Final Values)
-3.4
2-Sided
95
-22.1
15.4
Superiority
OG002
OG005
Difference for change from Baseline to Week 12 in ACQ response rate: MK-1029 60 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).
MN method
0.6991
Mean Difference (Final Values)
3.8
2-Sided
95
-15.6
22.6
Superiority
OG003
OG005
Difference for change from Baseline to Week 12 in ACQ response rate: MK-1029 150 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).
MN method
0.3934
Mean Difference (Final Values)
8.1
2-Sided
95
-10.6
26.2
Superiority
OG004
OG005
Difference for change from Baseline to Week 12 in ACQ response rate: Montelukast vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).
MN method
0.8032
Mean Difference (Final Values)
2.3
2-Sided
95
-16.0
20.5
Superiority
45
OG00447
OG00539
0.637
(0.011 to 1.262)
OG0040.248(-0.364 to 0.86)
OG0050.557(-0.115 to 1.230)
OG001
OG005
Difference in LS means for percent of asthma attack days over Week 6 to Week 12 of a 12-week treatment period: MK-1209 30 mg vs. Placebo. ANOVA model includes terms for prior ICS use (Yes/No) and treatment. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).
ANOVA
0.437
Mean Difference (Final Values)
-0.376
2-Sided
95
-1.326
0.575
Superiority
OG002
OG005
Difference in LS means for percent of asthma attack days over Week 6 to Week 12 of a 12-week treatment period: MK-1209 60 mg vs. Placebo. ANOVA model includes terms for prior ICS use (Yes/No) and treatment. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).
ANOVA
0.270
Mean Difference (Final Values)
-0.540
2-Sided
95
-1.504
0.423
Superiority
OG003
OG005
Difference in LS means for percent of asthma attack days over Week 6 to Week 12 of a 12-week treatment period: MK-1209 150 mg vs. Placebo. ANOVA model includes terms for prior ICS use (Yes/No) and treatment. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).
ANOVA
0.865
Mean Difference (Final Values)
0.079
2-Sided
95
-0.839
0.997
Superiority
OG004
OG005
Difference in LS means for percent of asthma attack days over Week 6 to Week 12 of a 12-week treatment period: Montelukast vs. Placebo. ANOVA model includes terms for prior ICS use (Yes/No) and treatment. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).