Study of MK-1029 in Participants With Persistent Asthma That Cannot Be Controlled With Montelukast (MK-1029-015)
Condition: Asthma
MeSH terms: Asthma
Intervention: MK-1029 150 mg; MK-1029 Matching-image Placebo; Montelukast 10 mg; Albuterol/Salbutamol 90 mcg - 100 mcg per inhalation
Intervention description: 150 mg tablet administered orally, once a day (QD), at bedtime; Matching-image placebo tablet administered orally, QD, at bedtime; 10 mg tablet administered orally, QD, at bedtime; 1 or 2 inhalations 4 times a day (QID) as needed (PRN) as a Rescue Medication
Intervention MeSH terms: Albuterol; Montelukast
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 142.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

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