Asthma
Conditions
Brief summary
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.
Interventions
DRUGMK-1029 150 mg
150 mg tablet administered orally, once a day (QD), at bedtime
DRUGMK-1029 Matching-image Placebo
Matching-image placebo tablet administered orally, QD, at bedtime
10 mg tablet administered orally, QD, at bedtime
DRUGAlbuterol/Salbutamol 90 mcg - 100 mcg per inhalation
1 or 2 inhalations 4 times a day (QID) as needed (PRN) as a Rescue Medication
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Symptoms of persistent asthma for at least one year * History of asthma treatments including as-needed inhaled short-acting beta-agonists (albuterol/salbutamol); stable doses of inhaled corticosteroids (ICS), combination ICS/long-acting (inhaled) Beta2-adrenergic agonist (LABA) and/or oral asthma controller(s) * Must be able to discontinue or taper asthma controlling medications while receiving Montelukast * No history of smoking or no smoking for at least 1 year, with a smoking history of no more than 10 pack-years * Body Mass Index (BMI) of 15 kg/m\^2 to 40 kg/m\^2. * Females must not be pregnant (negative serum human chorionic gonadotropin test) or breastfeeding and must not plan to become pregnant for the duration of the study, including the post-treatment follow-up period * Women and male participants of reproductive potential must agree to use adequate contraception for the duration of the study
Exclusion criteria
* Evidence of another active pulmonary disorder such as bronchiectasis or chronic obstructive pulmonary disease (COPD) * Unable to perform acceptable, repeatable spirometry * History of myocardial infarction, congestive heart failure, or uncontrolled cardiac arrhythmia within 3 months of screening visit * Major surgical procedure(s) within 4 weeks of screening visit * Blood donation within 2 weeks of screening visit * Treatment in an emergency room for asthma (within 4 weeks) or hospitalization for asthma or respiratory condition within 2 months of screening visit * Evidence of active sinus disease within 2 weeks of screening visit * Upper respiratory infection (viral or bacterial) within 1 month of screening visit * History of a psychiatric disorder within 3 months of screening visit * History of human immunodeficiency virus (HIV) * Unstable disease of the ophthalmologic, neurological, hepatic, renal, connective tissue, genitourinary, gastrointestinal, cardiovascular or hematologic systems * History of cancer (except for successfully treated basal and squamous cell carcinomas of the skin) within 5 years of screening visit * Uncontrolled hypertension * Participation in a clinical trial involving an investigational drug within 4 weeks of screening visit * Hypersensitivity or intolerance to inhaled beta-agonists and/or leukotriene inhibitors or any of their ingredients, including lactose and galactose * Known sensitivity to or has not had previous exposure to aspirin or non-steroidal anti-inflammatory drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline Pre-dose Forced Expiratory Volume in One Second (FEV1) | Before the first dose of study investigational product (Baseline) | FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second. |
| Average Change From Baseline in Pre-dose FEV1 at Week 4 and Week 6 | Before the first dose (Baseline) and at the end of Weeks 4 and 6 of treatment | 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 represents the average change from baseline at Week 4 and Week 6. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Discontinued Study Drug Due to an AE | Up to 6 weeks | 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. |
| Change From Baseline in Alkaline Phosphatase (ALP) at Week 6 | Baseline and Week 6 | Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline. |
| Change From Baseline in Alanine Aminotransferase (ALT) at Week 6 | Baseline and Week 6 | Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline. |
| Change From Baseline in Aspartate Aminotransferase (AST) at Week 6 | Baseline and Week 6 | Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline. |
| Change From Baseline in Bilirubin at Week 6 | Baseline and Week 6 | Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline. |
| Change From Baseline in Eosinophil (Percent [%]) at Week 6 | Baseline and Week 6 | Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline. |
| Change From Baseline in Neutrophil (%) at Week 6 | Baseline and Week 6 | Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline. |
| Change From Baseline in Platelet Count at Week 6 | Baseline and Week 6 | Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline. |
| Change From Baseline in White Blood Cell Count at Week 6 | Baseline and Week 6 | Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline. |
| Change From Baseline in Hematocrit (%) at Week 6 | Baseline and Week 6 | Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline. |
| Change From Baseline in Systolic Blood Pressure at Week 2 | Baseline and Week 2 | Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. |
| Percentage of Days With Worsening Asthma Average Over Weeks 3 to 6 | Up to 4 weeks | 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. Participants needed 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. |
| Change From Baseline in Systolic Blood Pressure at Week 6 | Baseline and Week 6 | Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. |
| Change From Baseline in Diastolic Blood Pressure at Week 2 | Baseline and Week 2 | Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. |
| Change From Baseline in Diastolic Blood Pressure at Week 4 | Baseline and Week 4 | Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. |
| Change From Baseline in Diastolic Blood Pressure at Week 6 | Baseline and Week 6 | Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. |
| Change From Baseline in Heart Rate at Week 2 | Baseline and Week 2 | Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. |
| Change From Baseline in Heart Rate at Week 4 | Baseline and Week 4 | Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. |
| Change From Baseline in Heart Rate at Week 6 | Baseline and Week 6 | Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. |
| Change From Baseline in Respiratory Rate at Week 2 | Baseline and Week 2 | Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. |
| Change From Baseline in Respiratory Rate at Week 4 | Baseline and Week 4 | Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. |
| Change From Baseline in Respiratory Rate at Week 6 | Baseline and Week 6 | Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. |
| Change From Baseline in Systolic Blood Pressure at Week 4 | Baseline and Week 4 | Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline. |
| Percentage of Participants Who Experienced an Adverse Event (AE) | Up to 8 weeks | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MK-1029 150 mg + Montelukast 10 mg 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. | 72 |
| MK-1029 Placebo + Montelukast 10 mg 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. | 70 |
| Total | 142 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 3 |
| Overall Study | Protocol Violation | 4 | 1 |
Baseline characteristics
| Characteristic | MK-1029 Placebo + Montelukast 10 mg | Total | MK-1029 150 mg + Montelukast 10 mg |
|---|---|---|---|
| Age, Continuous | 42.2 Years STANDARD_DEVIATION 13 | 43.3 Years STANDARD_DEVIATION 12.6 | 44.4 Years STANDARD_DEVIATION 12.1 |
| C Alleles at the pre-specified single nucleotide polymorphism (SNP) 1 copy | 47 Participants | 95 Participants | 48 Participants |
| C Alleles at the pre-specified single nucleotide polymorphism (SNP) 2 copies | 23 Participants | 47 Participants | 24 Participants |
| Pre beta-agonist (β-agonist) forced expiratory volume in one second (FEV1) Predicted | 2.243 Liter (L) STANDARD_DEVIATION 0.631 | 2.247 Liter (L) STANDARD_DEVIATION 0.6 | 2.251 Liter (L) STANDARD_DEVIATION 0.572 |
| Prior inhaled corticosteroid use No | 16 Participants | 36 Participants | 20 Participants |
| Prior inhaled corticosteroid use Yes | 54 Participants | 106 Participants | 52 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 42 Participants | 90 Participants | 48 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 10 Participants | 22 Participants | 12 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 26 Participants | 10 Participants |
| Sex: Female, Male Female | 46 Participants | 87 Participants | 41 Participants |
| Sex: Female, Male Male | 24 Participants | 55 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 70 | 0 / 69 |
| other Total, other adverse events | 6 / 70 | 9 / 69 |
| serious Total, serious adverse events | 0 / 70 | 1 / 69 |
Outcome results
Primary
Average Change From Baseline in Pre-dose FEV1 at Week 4 and Week 6
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 represents the average change from baseline at Week 4 and Week 6.
Time frame: Before the first dose (Baseline) and at the end of Weeks 4 and 6 of treatment
Population: Analysis population consists of randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| MK-1029 150 mg + Montelukast 10 mg | Average Change From Baseline in Pre-dose FEV1 at Week 4 and Week 6 | 0.152 Liter |
| MK-1029 Placebo + Montelukast 10 mg | Average Change From Baseline in Pre-dose FEV1 at Week 4 and Week 6 | 0.046 Liter |
p-value: 0.02395% CI: [0.015, 0.199]Constrained longitudinal data analysis
Primary
Baseline Pre-dose Forced Expiratory Volume in One Second (FEV1)
FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second.
Time frame: Before the first dose of study investigational product (Baseline)
Population: Analysis population consists of randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MK-1029 150 mg + Montelukast 10 mg | Baseline Pre-dose Forced Expiratory Volume in One Second (FEV1) | 2.264 Liter | Standard Deviation 0.566 |
| MK-1029 Placebo + Montelukast 10 mg | Baseline Pre-dose Forced Expiratory Volume in One Second (FEV1) | 2.234 Liter | Standard Deviation 0.612 |
Secondary
Change From Baseline in Alanine Aminotransferase (ALT) at Week 6
Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.
Time frame: Baseline and Week 6
Population: 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, ALT.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MK-1029 150 mg + Montelukast 10 mg | Change From Baseline in Alanine Aminotransferase (ALT) at Week 6 | Baseline | 22.33 IU/L | Standard Deviation 12.75 |
| MK-1029 150 mg + Montelukast 10 mg | Change From Baseline in Alanine Aminotransferase (ALT) at Week 6 | Change at Week 6 | -0.99 IU/L | Standard Deviation 9.84 |
| MK-1029 Placebo + Montelukast 10 mg | Change From Baseline in Alanine Aminotransferase (ALT) at Week 6 | Baseline | 19.35 IU/L | Standard Deviation 9.77 |
| MK-1029 Placebo + Montelukast 10 mg | Change From Baseline in Alanine Aminotransferase (ALT) at Week 6 | Change at Week 6 | 0.34 IU/L | Standard Deviation 6.31 |
Secondary
Change From Baseline in Alkaline Phosphatase (ALP) at Week 6
Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.
Time frame: Baseline and Week 6
Population: 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, ALP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MK-1029 150 mg + Montelukast 10 mg | Change From Baseline in Alkaline Phosphatase (ALP) at Week 6 | Baseline | 61.16 IU/L | Standard Deviation 19.05 |
| MK-1029 150 mg + Montelukast 10 mg | Change From Baseline in Alkaline Phosphatase (ALP) at Week 6 | Change at Week 6 | -0.83 IU/L | Standard Deviation 7.68 |
| MK-1029 Placebo + Montelukast 10 mg | Change From Baseline in Alkaline Phosphatase (ALP) at Week 6 | Baseline | 67.96 IU/L | Standard Deviation 21.17 |
| MK-1029 Placebo + Montelukast 10 mg | Change From Baseline in Alkaline Phosphatase (ALP) at Week 6 | Change at Week 6 | 0.44 IU/L | Standard Deviation 9.98 |
Secondary
Change From Baseline in Aspartate Aminotransferase (AST) at Week 6
Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.
Time frame: Baseline and Week 6
Population: 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, AST.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MK-1029 150 mg + Montelukast 10 mg | Change From Baseline in Aspartate Aminotransferase (AST) at Week 6 | Baseline | 23.53 IU/L | Standard Deviation 10.28 |
| MK-1029 150 mg + Montelukast 10 mg | Change From Baseline in Aspartate Aminotransferase (AST) at Week 6 | Change at Week 6 | -0.09 IU/L | Standard Deviation 12.52 |
| MK-1029 Placebo + Montelukast 10 mg | Change From Baseline in Aspartate Aminotransferase (AST) at Week 6 | Baseline | 20.64 IU/L | Standard Deviation 7.62 |
| MK-1029 Placebo + Montelukast 10 mg | Change From Baseline in Aspartate Aminotransferase (AST) at Week 6 | Change at Week 6 | 0.76 IU/L | Standard Deviation 7.67 |
Secondary
Change From Baseline in Bilirubin at Week 6
Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.
Time frame: Baseline and Week 6
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MK-1029 150 mg + Montelukast 10 mg | Change From Baseline in Bilirubin at Week 6 | Baseline | 0.62 mg/dL | Standard Deviation 0.25 |
| MK-1029 150 mg + Montelukast 10 mg | Change From Baseline in Bilirubin at Week 6 | Change at Week 6 | -0.00 mg/dL | Standard Deviation 0.25 |
| MK-1029 Placebo + Montelukast 10 mg | Change From Baseline in Bilirubin at Week 6 | Baseline | 0.54 mg/dL | Standard Deviation 0.21 |
| MK-1029 Placebo + Montelukast 10 mg | Change From Baseline in Bilirubin at Week 6 | Change at Week 6 | -0.01 mg/dL | Standard Deviation 0.2 |
Secondary
Change From Baseline in Diastolic Blood Pressure at Week 2
Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.
Time frame: Baseline and Week 2
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MK-1029 150 mg + Montelukast 10 mg | Change From Baseline in Diastolic Blood Pressure at Week 2 | Baseline | 74.40 mmHg | Standard Deviation 10.79 |
| MK-1029 150 mg + Montelukast 10 mg | Change From Baseline in Diastolic Blood Pressure at Week 2 | Change at Week 2 | -1.31 mmHg | Standard Deviation 7.67 |
| MK-1029 Placebo + Montelukast 10 mg | Change From Baseline in Diastolic Blood Pressure at Week 2 | Baseline | 74.45 mmHg | Standard Deviation 10.49 |
| MK-1029 Placebo + Montelukast 10 mg | Change From Baseline in Diastolic Blood Pressure at Week 2 | Change at Week 2 | -0.97 mmHg | Standard Deviation 6.88 |
Secondary
Change From Baseline in Diastolic Blood Pressure at Week 4
Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.
Time frame: Baseline and Week 4
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MK-1029 150 mg + Montelukast 10 mg | Change From Baseline in Diastolic Blood Pressure at Week 4 | Baseline | 74.60 mmHg | Standard Deviation 10.88 |
| MK-1029 150 mg + Montelukast 10 mg | Change From Baseline in Diastolic Blood Pressure at Week 4 | Change at Week 4 | -1.56 mmHg | Standard Deviation 7.71 |
| MK-1029 Placebo + Montelukast 10 mg | Change From Baseline in Diastolic Blood Pressure at Week 4 | Baseline | 74.42 mmHg | Standard Deviation 10.49 |
| MK-1029 Placebo + Montelukast 10 mg | Change From Baseline in Diastolic Blood Pressure at Week 4 | Change at Week 4 | -1.60 mmHg | Standard Deviation 8.01 |
Secondary
Change From Baseline in Diastolic Blood Pressure at Week 6
Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.
Time frame: Baseline and Week 6
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MK-1029 150 mg + Montelukast 10 mg | Change From Baseline in Diastolic Blood Pressure at Week 6 | Baseline | 74.60 mmHg | Standard Deviation 10.88 |
| MK-1029 150 mg + Montelukast 10 mg | Change From Baseline in Diastolic Blood Pressure at Week 6 | Change at Week 6 | -1.18 mmHg | Standard Deviation 8.3 |
| MK-1029 Placebo + Montelukast 10 mg | Change From Baseline in Diastolic Blood Pressure at Week 6 | Change at Week 6 | -0.95 mmHg | Standard Deviation 7.71 |
| MK-1029 Placebo + Montelukast 10 mg | Change From Baseline in Diastolic Blood Pressure at Week 6 | Baseline | 74.29 mmHg | Standard Deviation 10.51 |
Secondary
Change From Baseline in Eosinophil (Percent [%]) at Week 6
Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.
Time frame: Baseline and Week 6
Population: 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 (%).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MK-1029 150 mg + Montelukast 10 mg | Change From Baseline in Eosinophil (Percent [%]) at Week 6 | Baseline | 4.40 Percent of White Blood Cells | Standard Deviation 4.54 |
| MK-1029 150 mg + Montelukast 10 mg | Change From Baseline in Eosinophil (Percent [%]) at Week 6 | Change at Week 6 | 0.11 Percent of White Blood Cells | Standard Deviation 4.29 |
| MK-1029 Placebo + Montelukast 10 mg | Change From Baseline in Eosinophil (Percent [%]) at Week 6 | Baseline | 3.58 Percent of White Blood Cells | Standard Deviation 2.65 |
| MK-1029 Placebo + Montelukast 10 mg | Change From Baseline in Eosinophil (Percent [%]) at Week 6 | Change at Week 6 | 0.51 Percent of White Blood Cells | Standard Deviation 1.96 |
Secondary
Change From Baseline in Heart Rate at Week 2
Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.
Time frame: Baseline and Week 2
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MK-1029 150 mg + Montelukast 10 mg | Change From Baseline in Heart Rate at Week 2 | Baseline | 73.21 beats/min | Standard Deviation 10.96 |
| MK-1029 150 mg + Montelukast 10 mg | Change From Baseline in Heart Rate at Week 2 | Change at Week 2 | -0.60 beats/min | Standard Deviation 7.84 |
| MK-1029 Placebo + Montelukast 10 mg | Change From Baseline in Heart Rate at Week 2 | Baseline | 74.20 beats/min | Standard Deviation 10.03 |
| MK-1029 Placebo + Montelukast 10 mg | Change From Baseline in Heart Rate at Week 2 | Change at Week 2 | 0.45 beats/min | Standard Deviation 9.38 |
Secondary
Change From Baseline in Heart Rate at Week 4
Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.
Time frame: Baseline and Week 4
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MK-1029 150 mg + Montelukast 10 mg | Change From Baseline in Heart Rate at Week 4 | Baseline | 73.25 beats/min | Standard Deviation 11.12 |
| MK-1029 150 mg + Montelukast 10 mg | Change From Baseline in Heart Rate at Week 4 | Change at Week 4 | -1.82 beats/min | Standard Deviation 9.18 |
| MK-1029 Placebo + Montelukast 10 mg | Change From Baseline in Heart Rate at Week 4 | Baseline | 73.96 beats/min | Standard Deviation 10.01 |
| MK-1029 Placebo + Montelukast 10 mg | Change From Baseline in Heart Rate at Week 4 | Change at Week 4 | 1.40 beats/min | Standard Deviation 9.38 |
Secondary
Change From Baseline in Heart Rate at Week 6
Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.
Time frame: Baseline and Week 6
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MK-1029 150 mg + Montelukast 10 mg | Change From Baseline in Heart Rate at Week 6 | Baseline | 73.25 beats/min | Standard Deviation 11.12 |
| MK-1029 150 mg + Montelukast 10 mg | Change From Baseline in Heart Rate at Week 6 | Change at Week 6 | -0.84 beats/min | Standard Deviation 8.82 |
| MK-1029 Placebo + Montelukast 10 mg | Change From Baseline in Heart Rate at Week 6 | Baseline | 73.80 beats/min | Standard Deviation 10.01 |
| MK-1029 Placebo + Montelukast 10 mg | Change From Baseline in Heart Rate at Week 6 | Change at Week 6 | 1.06 beats/min | Standard Deviation 10.1 |
Secondary
Change From Baseline in Hematocrit (%) at Week 6
Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.
Time frame: Baseline and Week 6
Population: 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 (%).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MK-1029 150 mg + Montelukast 10 mg | Change From Baseline in Hematocrit (%) at Week 6 | Baseline | 42.79 Percent | Standard Deviation 3.98 |
| MK-1029 150 mg + Montelukast 10 mg | Change From Baseline in Hematocrit (%) at Week 6 | Change at Week 6 | -0.10 Percent | Standard Deviation 2.05 |
| MK-1029 Placebo + Montelukast 10 mg | Change From Baseline in Hematocrit (%) at Week 6 | Baseline | 42.64 Percent | Standard Deviation 4.62 |
| MK-1029 Placebo + Montelukast 10 mg | Change From Baseline in Hematocrit (%) at Week 6 | Change at Week 6 | -0.33 Percent | Standard Deviation 1.86 |
Secondary
Change From Baseline in Neutrophil (%) at Week 6
Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.
Time frame: Baseline and Week 6
Population: 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 (%).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MK-1029 150 mg + Montelukast 10 mg | Change From Baseline in Neutrophil (%) at Week 6 | Baseline | 59.13 Percent of White Blood Cells | Standard Deviation 10.3 |
| MK-1029 150 mg + Montelukast 10 mg | Change From Baseline in Neutrophil (%) at Week 6 | Change at Week 6 | -1.32 Percent of White Blood Cells | Standard Deviation 10.53 |
| MK-1029 Placebo + Montelukast 10 mg | Change From Baseline in Neutrophil (%) at Week 6 | Baseline | 57.86 Percent of White Blood Cells | Standard Deviation 10.48 |
| MK-1029 Placebo + Montelukast 10 mg | Change From Baseline in Neutrophil (%) at Week 6 | Change at Week 6 | 0.12 Percent of White Blood Cells | Standard Deviation 9.11 |
Secondary
Change From Baseline in Platelet Count at Week 6
Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.
Time frame: Baseline and Week 6
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MK-1029 150 mg + Montelukast 10 mg | Change From Baseline in Platelet Count at Week 6 | Baseline | 256.85 10^9 cells/L | Standard Deviation 60.83 |
| MK-1029 150 mg + Montelukast 10 mg | Change From Baseline in Platelet Count at Week 6 | Change at Week 6 | -4.97 10^9 cells/L | Standard Deviation 30.93 |
| MK-1029 Placebo + Montelukast 10 mg | Change From Baseline in Platelet Count at Week 6 | Baseline | 258.44 10^9 cells/L | Standard Deviation 70.23 |
| MK-1029 Placebo + Montelukast 10 mg | Change From Baseline in Platelet Count at Week 6 | Change at Week 6 | 2.65 10^9 cells/L | Standard Deviation 29.44 |
Secondary
Change From Baseline in Respiratory Rate at Week 2
Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.
Time frame: Baseline and Week 2
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MK-1029 150 mg + Montelukast 10 mg | Change From Baseline in Respiratory Rate at Week 2 | Baseline | 16.40 breaths/min | Standard Deviation 2.61 |
| MK-1029 150 mg + Montelukast 10 mg | Change From Baseline in Respiratory Rate at Week 2 | Change at Week 2 | -0.30 breaths/min | Standard Deviation 1.93 |
| MK-1029 Placebo + Montelukast 10 mg | Change From Baseline in Respiratory Rate at Week 2 | Baseline | 17.23 breaths/min | Standard Deviation 3.78 |
| MK-1029 Placebo + Montelukast 10 mg | Change From Baseline in Respiratory Rate at Week 2 | Change at Week 2 | -1.17 breaths/min | Standard Deviation 3.64 |
Secondary
Change From Baseline in Respiratory Rate at Week 4
Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.
Time frame: Baseline and Week 4
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MK-1029 150 mg + Montelukast 10 mg | Change From Baseline in Respiratory Rate at Week 4 | Baseline | 16.43 breaths/min | Standard Deviation 2.6 |
| MK-1029 150 mg + Montelukast 10 mg | Change From Baseline in Respiratory Rate at Week 4 | Change at Week 4 | -0.12 breaths/min | Standard Deviation 2.58 |
| MK-1029 Placebo + Montelukast 10 mg | Change From Baseline in Respiratory Rate at Week 4 | Baseline | 17.18 breaths/min | Standard Deviation 3.82 |
| MK-1029 Placebo + Montelukast 10 mg | Change From Baseline in Respiratory Rate at Week 4 | Change at Week 4 | -0.97 breaths/min | Standard Deviation 3.24 |
Secondary
Change From Baseline in Respiratory Rate at Week 6
Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.
Time frame: Baseline and Week 6
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MK-1029 150 mg + Montelukast 10 mg | Change From Baseline in Respiratory Rate at Week 6 | Baseline | 16.43 breaths/min | Standard Deviation 2.6 |
| MK-1029 150 mg + Montelukast 10 mg | Change From Baseline in Respiratory Rate at Week 6 | Change at Week 6 | -0.09 breaths/min | Standard Deviation 2.3 |
| MK-1029 Placebo + Montelukast 10 mg | Change From Baseline in Respiratory Rate at Week 6 | Baseline | 17.20 breaths/min | Standard Deviation 3.84 |
| MK-1029 Placebo + Montelukast 10 mg | Change From Baseline in Respiratory Rate at Week 6 | Change at Week 6 | -1.17 breaths/min | Standard Deviation 3.2 |
Secondary
Change From Baseline in Systolic Blood Pressure at Week 2
Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.
Time frame: Baseline and Week 2
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MK-1029 150 mg + Montelukast 10 mg | Change From Baseline in Systolic Blood Pressure at Week 2 | Baseline | 118.89 mmHg | Standard Deviation 16.28 |
| MK-1029 150 mg + Montelukast 10 mg | Change From Baseline in Systolic Blood Pressure at Week 2 | Change at Week 2 | -1.61 mmHg | Standard Deviation 9 |
| MK-1029 Placebo + Montelukast 10 mg | Change From Baseline in Systolic Blood Pressure at Week 2 | Baseline | 118.83 mmHg | Standard Deviation 15.64 |
| MK-1029 Placebo + Montelukast 10 mg | Change From Baseline in Systolic Blood Pressure at Week 2 | Change at Week 2 | -1.23 mmHg | Standard Deviation 10.79 |
Secondary
Change From Baseline in Systolic Blood Pressure at Week 4
Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.
Time frame: Baseline and Week 4
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MK-1029 150 mg + Montelukast 10 mg | Change From Baseline in Systolic Blood Pressure at Week 4 | Baseline | 119.40 mmHg | Standard Deviation 16.22 |
| MK-1029 150 mg + Montelukast 10 mg | Change From Baseline in Systolic Blood Pressure at Week 4 | Change at Week 4 | -2.13 mmHg | Standard Deviation 10.14 |
| MK-1029 Placebo + Montelukast 10 mg | Change From Baseline in Systolic Blood Pressure at Week 4 | Baseline | 118.82 mmHg | Standard Deviation 15.88 |
| MK-1029 Placebo + Montelukast 10 mg | Change From Baseline in Systolic Blood Pressure at Week 4 | Change at Week 4 | -1.99 mmHg | Standard Deviation 11.45 |
Secondary
Change From Baseline in Systolic Blood Pressure at Week 6
Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.
Time frame: Baseline and Week 6
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MK-1029 150 mg + Montelukast 10 mg | Change From Baseline in Systolic Blood Pressure at Week 6 | Baseline | 119.40 mmHg | Standard Deviation 16.22 |
| MK-1029 150 mg + Montelukast 10 mg | Change From Baseline in Systolic Blood Pressure at Week 6 | Change at Week 6 | -0.34 mmHg | Standard Deviation 9.36 |
| MK-1029 Placebo + Montelukast 10 mg | Change From Baseline in Systolic Blood Pressure at Week 6 | Baseline | 118.77 mmHg | Standard Deviation 16 |
| MK-1029 Placebo + Montelukast 10 mg | Change From Baseline in Systolic Blood Pressure at Week 6 | Change at Week 6 | -2.26 mmHg | Standard Deviation 11.11 |
Secondary
Change From Baseline in White Blood Cell Count at Week 6
Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.
Time frame: Baseline and Week 6
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MK-1029 150 mg + Montelukast 10 mg | Change From Baseline in White Blood Cell Count at Week 6 | Baseline | 6.76 10^9 cells/L | Standard Deviation 2.55 |
| MK-1029 150 mg + Montelukast 10 mg | Change From Baseline in White Blood Cell Count at Week 6 | Change at Week 6 | -0.08 10^9 cells/L | Standard Deviation 2 |
| MK-1029 Placebo + Montelukast 10 mg | Change From Baseline in White Blood Cell Count at Week 6 | Baseline | 6.53 10^9 cells/L | Standard Deviation 1.88 |
| MK-1029 Placebo + Montelukast 10 mg | Change From Baseline in White Blood Cell Count at Week 6 | Change at Week 6 | 0.09 10^9 cells/L | Standard Deviation 1.51 |
Secondary
Percentage of Days With Worsening Asthma Average Over Weeks 3 to 6
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. Participants needed 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.
Time frame: Up to 4 weeks
Population: 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 6 components used to determine asthma worsening are missing).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| MK-1029 150 mg + Montelukast 10 mg | Percentage of Days With Worsening Asthma Average Over Weeks 3 to 6 | 16.970 Percentage of days |
| MK-1029 Placebo + Montelukast 10 mg | Percentage of Days With Worsening Asthma Average Over Weeks 3 to 6 | 21.746 Percentage of days |
p-value: 0.35295% CI: [-14.92, 5.37]ANOVA
Secondary
Percentage of Participants Who Discontinued Study Drug Due to an AE
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.
Time frame: Up to 6 weeks
Population: Analysis population included all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK-1029 150 mg + Montelukast 10 mg | Percentage of Participants Who Discontinued Study Drug Due to an AE | 0.0 Percentage of participants |
| MK-1029 Placebo + Montelukast 10 mg | Percentage of Participants Who Discontinued Study Drug Due to an AE | 4.3 Percentage of participants |
95% CI: [-12.1, 1]
Secondary
Percentage of Participants Who Experienced an Adverse Event (AE)
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.
Time frame: Up to 8 weeks
Population: Analysis population included all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK-1029 150 mg + Montelukast 10 mg | Percentage of Participants Who Experienced an Adverse Event (AE) | 25.7 Percentage of participants |
| MK-1029 Placebo + Montelukast 10 mg | Percentage of Participants Who Experienced an Adverse Event (AE) | 26.1 Percentage of participants |
95% CI: [-15, 14.3]