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