Study of MK-1029 in Participants With Persistent Asthma T... | NCT02720081

ID	Type	Description
2015-005054-36	EudraCT Number
MK-1029-015	Other Identifier	Merck Registration Number
163313	Registry Identifier	JAPIC-CTI

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MK-1029 150 mg + Montelukast 10 mg	Experimental	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.	Drug: MK-1029 150 mg Drug: Montelukast 10 mg Drug: Albuterol/Salbutamol 90 mcg - 100 mcg per inhalation
MK-1029 Placebo + Montelukast 10 mg	Placebo Comparator	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.	Drug: MK-1029 Matching-image Placebo Drug: Montelukast 10 mg Drug: Albuterol/Salbutamol 90 mcg - 100 mcg per inhalation

Name	Type	Description	Arm Group Labels	Other Names
MK-1029 150 mg	Drug	150 mg tablet administered orally, once a day (QD), at bedtime	MK-1029 150 mg + Montelukast 10 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Baseline Pre-dose Forced Expiratory Volume in One Second (FEV1)	FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second.	Before the first dose of study investigational product (Baseline)
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.	Before the first dose (Baseline) and at the end of Weeks 4 and 6 of treatment

Secondary Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

Eligibility Criteria

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

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Mar 3, 2016

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00072 BG00170 BG002142

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	OG0002.264± 0.566 OG0012.234± 0.612

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.

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).

Posted

Least Squares Mean

95% Confidence Interval

Percentage of days

Up to 4 weeks

ID	Title	Description
OG000	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.

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.

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

Posted

Number

Percentage of participants

Up to 8 weeks

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Percentage of Participants Who Discontinued Study Drug Due to an AE

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

Posted

Number

Percentage of participants

Up to 6 weeks

ID	Title	Description
OG000	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.
OG001	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.

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.

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.

Posted

Mean

Standard Deviation

IU/L

Baseline and Week 6

ID	Title	Description
OG000	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.
OG001	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.

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.

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.

Posted

Mean

Standard Deviation

IU/L

Baseline and Week 6

ID	Title	Description
OG000	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.
OG001	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.

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.

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.

Posted

Mean

Standard Deviation

IU/L

Baseline and Week 6

ID	Title	Description
OG000	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.
OG001	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.

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.

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.

Posted

Mean

Standard Deviation

mg/dL

Baseline and Week 6

ID	Title	Description
OG000	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.
OG001	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.

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.

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 (%).

Posted

Mean

Standard Deviation

Percent of White Blood Cells

Baseline and Week 6

ID	Title	Description
OG000	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.
OG001	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.

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.

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 (%).

Posted

Mean

Standard Deviation

Percent of White Blood Cells

Baseline and Week 6

ID	Title	Description
OG000	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.
OG001	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.

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.

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.

Posted

Mean

Standard Deviation

10^9 cells/L

Baseline and Week 6

ID	Title	Description
OG000	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.
OG001	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.

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.

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.

Posted

Mean

Standard Deviation

10^9 cells/L

Baseline and Week 6

ID	Title	Description
OG000	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.
OG001	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.

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.

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 (%).

Posted

Mean

Standard Deviation

Percent

Baseline and Week 6

ID	Title	Description
OG000	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.
OG001	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.

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.

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.

Posted

Mean

Standard Deviation

mmHg

Baseline and Week 2

ID	Title	Description
OG000	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.
OG001	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.

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.

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.

Posted

Mean

Standard Deviation

mmHg

Baseline and Week 4

ID	Title	Description
OG000	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.
OG001	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.

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.

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.

Posted

Mean

Standard Deviation

mmHg

Baseline and Week 6

ID	Title	Description
OG000	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.
OG001	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.

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.

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.

Posted

Mean

Standard Deviation

mmHg

Baseline and Week 2

ID	Title	Description
OG000	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.
OG001	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.

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.

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.

Posted

Mean

Standard Deviation

mmHg

Baseline and Week 4

ID	Title	Description
OG000	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.
OG001	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.

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.

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.

Posted

Mean

Standard Deviation

mmHg

Baseline and Week 6

ID	Title	Description
OG000	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.
OG001	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.

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.

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.

Posted

Mean

Standard Deviation

beats/min

Baseline and Week 2

ID	Title	Description
OG000	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.
OG001	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.

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.

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.

Posted

Mean

Standard Deviation

beats/min

Baseline and Week 4

ID	Title	Description
OG000	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.
OG001	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.

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.

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.

Posted

Mean

Standard Deviation

beats/min

Baseline and Week 6

ID	Title	Description
OG000	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.
OG001	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.

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.

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.

Posted

Mean

Standard Deviation

breaths/min

Baseline and Week 2

ID	Title	Description
OG000	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.
OG001	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.

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.

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.

Posted

Mean

Standard Deviation

breaths/min

Baseline and Week 4

ID	Title	Description
OG000	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.
OG001	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.

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.

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.

Posted

Mean

Standard Deviation

breaths/min

Baseline and Week 6

ID	Title	Description
OG000	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.
OG001	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.

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.

Analysis population consists of randomized participants who received at least 1 dose of study drug.

Posted

Least Squares Mean

95% Confidence Interval

Liter

Before the first dose (Baseline) and at the end of Weeks 4 and 6 of treatment

ID	Title	Description
OG000	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.
OG001	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.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	MK-1029 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.	0	70	0	70	6	70
EG001	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.	0	69	1	69	9	69

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected70 at risk EG0015 events4 affected69 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0004 events4 affected70 at risk EG0010 events0 affected69 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected70 at risk EG0018 events8 affected69 at risk

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012130	Respiratory Hypersensitivity
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

ID	Term
C093875	montelukast
D000420	Albuterol

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D000588	Amines
D010627	Phenethylamines
D005021	Ethylamines