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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: MK-1029 Matching-image Placebo; Drug: Albuterol/Salbutamol 90 mcg - 100 mcg per inhalation; Drug: Montelukast 10 mg; Drug: MK-1029 150 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02720081

MK-1029-015 (Other Identifier)

1029-015

2015-005054-36 (EudraCT Number)

163313 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 142 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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142 participants in 2 patient groups, including a placebo group

MK-1029 150 mg + Montelukast 10 mg

Experimental group

Description:

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.

Treatment:

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 group

Description:

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.

Treatment:

Drug: Montelukast 10 mg

Drug: Albuterol/Salbutamol 90 mcg - 100 mcg per inhalation

Drug: MK-1029 Matching-image Placebo