Trial Outcomes & Findings for Study of MK-1029 in Participants With Persistent Asthma That Cannot Be Controlled With Montelukast (MK-1029-015) (NCT NCT02720081)

NCT ID: NCT02720081

Last Updated: 2018-09-27

Results Overview

FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 142 participants
• Primary outcome timeframe: Before the first dose of study investigational product (Baseline)
• Results posted on: 2018-09-27

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	72	70
Overall Study Treated	70	69
Overall Study COMPLETED	68	66
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Measure	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.	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.
Overall Study Adverse Event	0	3
Overall Study Protocol Violation	4	1

Baseline Characteristics

Analysis population consists of participants with pre β-agonist FEV1 predicted baseline data.

Baseline characteristics by cohort

Measure	MK-1029 150 mg + Montelukast 10 mg n=72 Participants 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.	MK-1029 Placebo + Montelukast 10 mg n=70 Participants 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.	Total n=142 Participants Total of all reporting groups
Age, Continuous	44.4 Years STANDARD_DEVIATION 12.1 • n=72 Participants	42.2 Years STANDARD_DEVIATION 13.0 • n=70 Participants	43.3 Years STANDARD_DEVIATION 12.6 • n=142 Participants
Sex: Female, Male Female	41 Participants n=72 Participants	46 Participants n=70 Participants	87 Participants n=142 Participants
Sex: Female, Male Male	31 Participants n=72 Participants	24 Participants n=70 Participants	55 Participants n=142 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=72 Participants	2 Participants n=70 Participants	4 Participants n=142 Participants
Race (NIH/OMB) Asian	48 Participants n=72 Participants	42 Participants n=70 Participants	90 Participants n=142 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=72 Participants	0 Participants n=70 Participants	0 Participants n=142 Participants
Race (NIH/OMB) Black or African American	0 Participants n=72 Participants	0 Participants n=70 Participants	0 Participants n=142 Participants
Race (NIH/OMB) White	10 Participants n=72 Participants	16 Participants n=70 Participants	26 Participants n=142 Participants
Race (NIH/OMB) More than one race	12 Participants n=72 Participants	10 Participants n=70 Participants	22 Participants n=142 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=72 Participants	0 Participants n=70 Participants	0 Participants n=142 Participants
Pre beta-agonist (β-agonist) forced expiratory volume in one second (FEV1) Predicted	2.251 Liter (L) STANDARD_DEVIATION 0.572 • n=70 Participants • Analysis population consists of participants with pre β-agonist FEV1 predicted baseline data.	2.243 Liter (L) STANDARD_DEVIATION 0.631 • n=69 Participants • Analysis population consists of participants with pre β-agonist FEV1 predicted baseline data.	2.247 Liter (L) STANDARD_DEVIATION 0.600 • n=139 Participants • Analysis population consists of participants with pre β-agonist FEV1 predicted baseline data.
C Alleles at the pre-specified single nucleotide polymorphism (SNP) 1 copy	48 Participants n=72 Participants	47 Participants n=70 Participants	95 Participants n=142 Participants
C Alleles at the pre-specified single nucleotide polymorphism (SNP) 2 copies	24 Participants n=72 Participants	23 Participants n=70 Participants	47 Participants n=142 Participants
Prior inhaled corticosteroid use Yes	52 Participants n=72 Participants	54 Participants n=70 Participants	106 Participants n=142 Participants
Prior inhaled corticosteroid use No	20 Participants n=72 Participants	16 Participants n=70 Participants	36 Participants n=142 Participants

PRIMARY outcome

Timeframe: 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.

FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second.

Outcome measures

Measure	MK-1029 150 mg + Montelukast 10 mg n=70 Participants 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.	MK-1029 Placebo + Montelukast 10 mg n=69 Participants 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.
Baseline Pre-dose Forced Expiratory Volume in One Second (FEV1)	2.264 Liter Standard Deviation 0.566	2.234 Liter Standard Deviation 0.612

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	MK-1029 150 mg + Montelukast 10 mg n=70 Participants 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.	MK-1029 Placebo + Montelukast 10 mg n=69 Participants 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.
Average Change From Baseline in Pre-dose FEV1 at Week 4 and Week 6	0.152 Liter Interval 0.088 to 0.217	0.046 Liter Interval -0.02 to 0.111

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	MK-1029 150 mg + Montelukast 10 mg n=52 Participants 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.	MK-1029 Placebo + Montelukast 10 mg n=44 Participants 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.
Percentage of Days With Worsening Asthma Average Over Weeks 3 to 6	16.970 Percentage of days Interval 10.115 to 23.826	21.746 Percentage of days Interval 14.291 to 29.201

SECONDARY outcome

Timeframe: Up to 8 weeks

Population: Analysis population included all randomized participants who received at least 1 dose of study drug.

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.

Outcome measures

Measure	MK-1029 150 mg + Montelukast 10 mg n=70 Participants 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.	MK-1029 Placebo + Montelukast 10 mg n=69 Participants 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.
Percentage of Participants Who Experienced an Adverse Event (AE)	25.7 Percentage of participants	26.1 Percentage of participants

SECONDARY outcome

Timeframe: Up to 6 weeks

Population: Analysis population included all randomized participants who received at least 1 dose of study drug.

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.

Outcome measures

Measure	MK-1029 150 mg + Montelukast 10 mg n=70 Participants 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.	MK-1029 Placebo + Montelukast 10 mg n=69 Participants 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.
Percentage of Participants Who Discontinued Study Drug Due to an AE	0.0 Percentage of participants	4.3 Percentage of participants

SECONDARY outcome

Timeframe: 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.

Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.

Outcome measures

Measure	MK-1029 150 mg + Montelukast 10 mg n=70 Participants 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.	MK-1029 Placebo + Montelukast 10 mg n=68 Participants 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.
Change From Baseline in Alkaline Phosphatase (ALP) at Week 6 Baseline	61.16 IU/L Standard Deviation 19.05	67.96 IU/L Standard Deviation 21.17
Change From Baseline in Alkaline Phosphatase (ALP) at Week 6 Change at Week 6	-0.83 IU/L Standard Deviation 7.68	0.44 IU/L Standard Deviation 9.98

SECONDARY outcome

Timeframe: 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.

Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.

Outcome measures

Measure	MK-1029 150 mg + Montelukast 10 mg n=70 Participants 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.	MK-1029 Placebo + Montelukast 10 mg n=68 Participants 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.
Change From Baseline in Alanine Aminotransferase (ALT) at Week 6 Baseline	22.33 IU/L Standard Deviation 12.75	19.35 IU/L Standard Deviation 9.77
Change From Baseline in Alanine Aminotransferase (ALT) at Week 6 Change at Week 6	-0.99 IU/L Standard Deviation 9.84	0.34 IU/L Standard Deviation 6.31

SECONDARY outcome

Timeframe: 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.

Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.

Outcome measures

Measure	MK-1029 150 mg + Montelukast 10 mg n=70 Participants 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.	MK-1029 Placebo + Montelukast 10 mg n=67 Participants 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.
Change From Baseline in Aspartate Aminotransferase (AST) at Week 6 Baseline	23.53 IU/L Standard Deviation 10.28	20.64 IU/L Standard Deviation 7.62
Change From Baseline in Aspartate Aminotransferase (AST) at Week 6 Change at Week 6	-0.09 IU/L Standard Deviation 12.52	0.76 IU/L Standard Deviation 7.67

SECONDARY outcome

Timeframe: 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.

Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.

Outcome measures

Measure	MK-1029 150 mg + Montelukast 10 mg n=70 Participants 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.	MK-1029 Placebo + Montelukast 10 mg n=68 Participants 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.
Change From Baseline in Bilirubin at Week 6 Baseline	0.62 mg/dL Standard Deviation 0.25	0.54 mg/dL Standard Deviation 0.21
Change From Baseline in Bilirubin at Week 6 Change at Week 6	-0.00 mg/dL Standard Deviation 0.25	-0.01 mg/dL Standard Deviation 0.20

SECONDARY outcome

Timeframe: 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 (%).

Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.

Outcome measures

Measure	MK-1029 150 mg + Montelukast 10 mg n=69 Participants 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.	MK-1029 Placebo + Montelukast 10 mg n=68 Participants 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.
Change From Baseline in Eosinophil (Percent [%]) at Week 6 Baseline	4.40 Percent of White Blood Cells Standard Deviation 4.54	3.58 Percent of White Blood Cells Standard Deviation 2.65
Change From Baseline in Eosinophil (Percent [%]) at Week 6 Change at Week 6	0.11 Percent of White Blood Cells Standard Deviation 4.29	0.51 Percent of White Blood Cells Standard Deviation 1.96

SECONDARY outcome

Timeframe: 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 (%).

Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.

Outcome measures

Measure	MK-1029 150 mg + Montelukast 10 mg n=69 Participants 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.	MK-1029 Placebo + Montelukast 10 mg n=68 Participants 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.
Change From Baseline in Neutrophil (%) at Week 6 Baseline	59.13 Percent of White Blood Cells Standard Deviation 10.30	57.86 Percent of White Blood Cells Standard Deviation 10.48
Change From Baseline in Neutrophil (%) at Week 6 Change at Week 6	-1.32 Percent of White Blood Cells Standard Deviation 10.53	0.12 Percent of White Blood Cells Standard Deviation 9.11

SECONDARY outcome

Timeframe: 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.

Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.

Outcome measures

Measure	MK-1029 150 mg + Montelukast 10 mg n=68 Participants 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.	MK-1029 Placebo + Montelukast 10 mg n=68 Participants 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.
Change From Baseline in Platelet Count at Week 6 Baseline	256.85 10^9 cells/L Standard Deviation 60.83	258.44 10^9 cells/L Standard Deviation 70.23
Change From Baseline in Platelet Count at Week 6 Change at Week 6	-4.97 10^9 cells/L Standard Deviation 30.93	2.65 10^9 cells/L Standard Deviation 29.44

SECONDARY outcome

Timeframe: 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.

Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.

Outcome measures

Measure	MK-1029 150 mg + Montelukast 10 mg n=69 Participants 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.	MK-1029 Placebo + Montelukast 10 mg n=68 Participants 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.
Change From Baseline in White Blood Cell Count at Week 6 Baseline	6.76 10^9 cells/L Standard Deviation 2.55	6.53 10^9 cells/L Standard Deviation 1.88
Change From Baseline in White Blood Cell Count at Week 6 Change at Week 6	-0.08 10^9 cells/L Standard Deviation 2.00	0.09 10^9 cells/L Standard Deviation 1.51

SECONDARY outcome

Timeframe: 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 (%).

Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.

Outcome measures

Measure	MK-1029 150 mg + Montelukast 10 mg n=69 Participants 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.	MK-1029 Placebo + Montelukast 10 mg n=68 Participants 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.
Change From Baseline in Hematocrit (%) at Week 6 Baseline	42.79 Percent Standard Deviation 3.98	42.64 Percent Standard Deviation 4.62
Change From Baseline in Hematocrit (%) at Week 6 Change at Week 6	-0.10 Percent Standard Deviation 2.05	-0.33 Percent Standard Deviation 1.86

SECONDARY outcome

Timeframe: 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.

Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.

Outcome measures

Measure	MK-1029 150 mg + Montelukast 10 mg n=70 Participants 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.	MK-1029 Placebo + Montelukast 10 mg n=69 Participants 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.
Change From Baseline in Systolic Blood Pressure at Week 2 Baseline	118.89 mmHg Standard Deviation 16.28	118.83 mmHg Standard Deviation 15.64
Change From Baseline in Systolic Blood Pressure at Week 2 Change at Week 2	-1.61 mmHg Standard Deviation 9.00	-1.23 mmHg Standard Deviation 10.79

SECONDARY outcome

Timeframe: 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.

Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.

Outcome measures

Measure	MK-1029 150 mg + Montelukast 10 mg n=68 Participants 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.	MK-1029 Placebo + Montelukast 10 mg n=67 Participants 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.
Change From Baseline in Systolic Blood Pressure at Week 4 Baseline	119.40 mmHg Standard Deviation 16.22	118.82 mmHg Standard Deviation 15.88
Change From Baseline in Systolic Blood Pressure at Week 4 Change at Week 4	-2.13 mmHg Standard Deviation 10.14	-1.99 mmHg Standard Deviation 11.45

SECONDARY outcome

Timeframe: 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.

Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.

Outcome measures

Measure	MK-1029 150 mg + Montelukast 10 mg n=68 Participants 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.	MK-1029 Placebo + Montelukast 10 mg n=66 Participants 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.
Change From Baseline in Systolic Blood Pressure at Week 6 Baseline	119.40 mmHg Standard Deviation 16.22	118.77 mmHg Standard Deviation 16.00
Change From Baseline in Systolic Blood Pressure at Week 6 Change at Week 6	-0.34 mmHg Standard Deviation 9.36	-2.26 mmHg Standard Deviation 11.11

SECONDARY outcome

Timeframe: 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.

Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.

Outcome measures

Measure	MK-1029 150 mg + Montelukast 10 mg n=70 Participants 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.	MK-1029 Placebo + Montelukast 10 mg n=69 Participants 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.
Change From Baseline in Diastolic Blood Pressure at Week 2 Baseline	74.40 mmHg Standard Deviation 10.79	74.45 mmHg Standard Deviation 10.49
Change From Baseline in Diastolic Blood Pressure at Week 2 Change at Week 2	-1.31 mmHg Standard Deviation 7.67	-0.97 mmHg Standard Deviation 6.88

SECONDARY outcome

Timeframe: 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.

Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.

Outcome measures

Measure	MK-1029 150 mg + Montelukast 10 mg n=68 Participants 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.	MK-1029 Placebo + Montelukast 10 mg n=67 Participants 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.
Change From Baseline in Diastolic Blood Pressure at Week 4 Baseline	74.60 mmHg Standard Deviation 10.88	74.42 mmHg Standard Deviation 10.49
Change From Baseline in Diastolic Blood Pressure at Week 4 Change at Week 4	-1.56 mmHg Standard Deviation 7.71	-1.60 mmHg Standard Deviation 8.01

SECONDARY outcome

Timeframe: 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.

Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.

Outcome measures

Measure	MK-1029 150 mg + Montelukast 10 mg n=68 Participants 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.	MK-1029 Placebo + Montelukast 10 mg n=66 Participants 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.
Change From Baseline in Diastolic Blood Pressure at Week 6 Baseline	74.60 mmHg Standard Deviation 10.88	74.29 mmHg Standard Deviation 10.51
Change From Baseline in Diastolic Blood Pressure at Week 6 Change at Week 6	-1.18 mmHg Standard Deviation 8.30	-0.95 mmHg Standard Deviation 7.71

SECONDARY outcome

Timeframe: 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.

Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.

Outcome measures

Measure	MK-1029 150 mg + Montelukast 10 mg n=70 Participants 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.	MK-1029 Placebo + Montelukast 10 mg n=69 Participants 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.
Change From Baseline in Heart Rate at Week 2 Baseline	73.21 beats/min Standard Deviation 10.96	74.20 beats/min Standard Deviation 10.03
Change From Baseline in Heart Rate at Week 2 Change at Week 2	-0.60 beats/min Standard Deviation 7.84	0.45 beats/min Standard Deviation 9.38

SECONDARY outcome

Timeframe: 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.

Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.

Outcome measures

Measure	MK-1029 150 mg + Montelukast 10 mg n=68 Participants 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.	MK-1029 Placebo + Montelukast 10 mg n=67 Participants 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.
Change From Baseline in Heart Rate at Week 4 Baseline	73.25 beats/min Standard Deviation 11.12	73.96 beats/min Standard Deviation 10.01
Change From Baseline in Heart Rate at Week 4 Change at Week 4	-1.82 beats/min Standard Deviation 9.18	1.40 beats/min Standard Deviation 9.38

SECONDARY outcome

Timeframe: 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.

Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.

Outcome measures

Measure	MK-1029 150 mg + Montelukast 10 mg n=68 Participants 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.	MK-1029 Placebo + Montelukast 10 mg n=66 Participants 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.
Change From Baseline in Heart Rate at Week 6 Baseline	73.25 beats/min Standard Deviation 11.12	73.80 beats/min Standard Deviation 10.01
Change From Baseline in Heart Rate at Week 6 Change at Week 6	-0.84 beats/min Standard Deviation 8.82	1.06 beats/min Standard Deviation 10.10

SECONDARY outcome

Timeframe: 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.

Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.

Outcome measures

Measure	MK-1029 150 mg + Montelukast 10 mg n=70 Participants 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.	MK-1029 Placebo + Montelukast 10 mg n=69 Participants 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.
Change From Baseline in Respiratory Rate at Week 2 Baseline	16.40 breaths/min Standard Deviation 2.61	17.23 breaths/min Standard Deviation 3.78
Change From Baseline in Respiratory Rate at Week 2 Change at Week 2	-0.30 breaths/min Standard Deviation 1.93	-1.17 breaths/min Standard Deviation 3.64

SECONDARY outcome

Timeframe: 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.

Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.

Outcome measures

Measure	MK-1029 150 mg + Montelukast 10 mg n=68 Participants 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.	MK-1029 Placebo + Montelukast 10 mg n=67 Participants 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.
Change From Baseline in Respiratory Rate at Week 4 Baseline	16.43 breaths/min Standard Deviation 2.60	17.18 breaths/min Standard Deviation 3.82
Change From Baseline in Respiratory Rate at Week 4 Change at Week 4	-0.12 breaths/min Standard Deviation 2.58	-0.97 breaths/min Standard Deviation 3.24

SECONDARY outcome

Timeframe: 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.

Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.

Outcome measures

Measure	MK-1029 150 mg + Montelukast 10 mg n=68 Participants 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.	MK-1029 Placebo + Montelukast 10 mg n=66 Participants 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.
Change From Baseline in Respiratory Rate at Week 6 Baseline	16.43 breaths/min Standard Deviation 2.60	17.20 breaths/min Standard Deviation 3.84
Change From Baseline in Respiratory Rate at Week 6 Change at Week 6	-0.09 breaths/min Standard Deviation 2.30	-1.17 breaths/min Standard Deviation 3.20

Adverse Events

MK-1029 150 mg + Montelukast 10 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

MK-1029 Placebo + Montelukast 10 mg

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	MK-1029 150 mg + Montelukast 10 mg n=70 participants at risk 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.	MK-1029 Placebo + Montelukast 10 mg n=69 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/70 • Up to 8 weeks Analysis population included all randomized participants who received at least 1 dose of study drug.	1.4% 1/69 • Number of events 1 • Up to 8 weeks Analysis population included all randomized participants who received at least 1 dose of study drug.

Other adverse events

Measure	MK-1029 150 mg + Montelukast 10 mg n=70 participants at risk 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.	MK-1029 Placebo + Montelukast 10 mg n=69 participants at risk 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.
Infections and infestations Upper respiratory tract infection	1.4% 1/70 • Number of events 1 • Up to 8 weeks Analysis population included all randomized participants who received at least 1 dose of study drug.	5.8% 4/69 • Number of events 5 • Up to 8 weeks Analysis population included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Viral upper respiratory tract infection	5.7% 4/70 • Number of events 4 • Up to 8 weeks Analysis population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/69 • Up to 8 weeks Analysis population included all randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Asthma	2.9% 2/70 • Number of events 2 • Up to 8 weeks Analysis population included all randomized participants who received at least 1 dose of study drug.	11.6% 8/69 • Number of events 8 • Up to 8 weeks Analysis population included all randomized participants who received at least 1 dose of study drug.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
• Publication restrictions are in place

Restriction type: OTHER