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

• Status: Completed
• Trial end date: 2017-09-06
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Albuterol; Montelukast

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