Study of MK-1029 in Participants With Persistent Asthma That Cannot Be Controlled With Montelukast (MK-1029-015)

NCT ID: NCT02720081

Last Updated: 2018-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-11
• Study Completion Date: 2017-09-06

Brief Summary

The purpose of this trial is to compare the safety, tolerability, and efficacy of adding MK-1029 to montelukast in adults with persistent asthma that is uncontrolled while receiving montelukast alone. Participants will have a specific genetic marker for clinical efficacy of MK-1029. The primary hypothesis is that when added to montelukast, treatment with MK-1029 is superior to placebo, as demonstrated by an increase in forced expiratory volume in one second (FEV1), measured as the average change from baseline at the end of Week 4 and Week 6 of treatment.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

MK-1029 150 mg

Intervention Type: DRUG

150 mg tablet administered orally, once a day (QD), at bedtime

Montelukast 10 mg

Intervention Type: DRUG

10 mg tablet administered orally, QD, at bedtime

Albuterol/Salbutamol 90 mcg - 100 mcg per inhalation

Intervention Type: DRUG

1 or 2 inhalations 4 times a day (QID) as needed (PRN) as a Rescue Medication

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.

Group Type: PLACEBO_COMPARATOR

MK-1029 Matching-image Placebo

Intervention Type: DRUG

Matching-image placebo tablet administered orally, QD, at bedtime

Montelukast 10 mg

Intervention Type: DRUG

10 mg tablet administered orally, QD, at bedtime

Albuterol/Salbutamol 90 mcg - 100 mcg per inhalation

Intervention Type: DRUG

1 or 2 inhalations 4 times a day (QID) as needed (PRN) as a Rescue Medication

Interventions

MK-1029 150 mg

150 mg tablet administered orally, once a day (QD), at bedtime

Intervention Type: DRUG

MK-1029 Matching-image Placebo

Matching-image placebo tablet administered orally, QD, at bedtime

Intervention Type: DRUG

Montelukast 10 mg

10 mg tablet administered orally, QD, at bedtime

Intervention Type: DRUG

Albuterol/Salbutamol 90 mcg - 100 mcg per inhalation

1 or 2 inhalations 4 times a day (QID) as needed (PRN) as a Rescue Medication

Intervention Type: DRUG

Other Intervention Names

SINGULAIR®; Montelukast sodium

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2015-005054-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MK-1029-015

Identifier Type: OTHER

Identifier Source: secondary_id

163313

Identifier Type: REGISTRY

Identifier Source: secondary_id

1029-015

Identifier Type: -

Identifier Source: org_study_id