study of mk-1029 in participants with persistent asthma that cannot be controlled with montelukast (mk-1029-015)

Conditions: Asthma

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.


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