A Dose-Ranging Study of MK-1029 in Adults With Persistent Asthma (MK-1029-012)
Condition: Asthma
MeSH terms: Asthma
Intervention: MK-1029; Montelukast 10 mg; Placebo
Intervention description: MK-1029 10 mg, 30 mg or 150 mg oral tablets taken QD at bedtime, based on randomization.; Parts I-II: Participants will receive Montelukast 10 mg tablets QD; Parts I-II: Participants will receive Placebo tablets QD
Intervention MeSH terms: Montelukast
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 576.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This adaptive design, dose-ranging study of MK-1029 will assess the dose-related efficacy and
      safety of MK-1029 compared with placebo using measures of lung function (forced expiratory
      volume in 1 second [FEV1]). The primary objectives are (1) To demonstrate that MK-1029,
      compared with placebo, results in dose-related improvements in FEV1 over the last 6 weeks of
      the 12-week active-treatment period; and (2) To determine the dose-related safety and
      tolerability of MK-1029 as monotherapy and as concomitant dosing with montelukast over 12
      weeks. The primary hypothesis is: MK-1029 is superior to placebo in a dose-related fashion in
      the average change from baseline in FEV1 over the last 6 weeks of the 12-week
      active-treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  not pregnant or breastfeeding, and not planning to become pregnant during the study

          -  history of symptoms of persistent asthma for at least one year

          -  current use of acceptable asthma treatments and willingness to taper or discontinue
             these treatments; acceptable asthma treatments:

               -  use of inhaled SABAs (e.g., albuterol/salbutamol) only "as-needed" with no use of
                  asthma controller medications; OR

               -  use of stable doses of low- or medium-dose inhaled corticosteroids (ICS), alone,
                  or in combination with either a long-acting beta-agonist (LABA) or other asthma
                  controller medications (including leukotriene receptor antagonists) and can
                  tolerate tapering or discontinuation

          -  no history of smoking OR no smoking within <1 year with a smoking history of ≤10
             pack-years

          -  ability to maintain a constant day/night, awake/sleep cycle

          -  agreement to not change habitual consumption of beverages or food containing caffeine
             throughout the study

          -  Body Mass Index (BMI) of 15 to 40 kg/m^2

        Exclusion Criteria:

          -  myocardial infarction, congestive heart failure, or uncontrolled cardiac arrhythmia
             within past ≤3 months

          -  hospitalization within past ≤4 weeks

          -  major surgical procedure within past ≤4 weeks

          -  participation in a clinical study involving an investigational drug within past ≤4
             weeks

          -  current regular use or recent (within past ≤5 years) past abuse of alcohol (>14
             drinks/week) or illicit drugs

          -  donation of a unit of blood within past ≤2 weeks or intention to donate a unit of
             blood during the study

          -  evidence of another clinically significant, active pulmonary disorder such as chronic
             obstructive pulmonary disease (COPD)

          -  emergency room treatment for asthma within past ≤4 weeks or hospitalization for asthma
             within past ≤8 weeks

          -  respiratory tract infection requiring antibiotic treatment within past ≤8 weeks

          -  evidence of active, clinically significant sinus disease within past ≤1 week

          -  history of a clinically significant psychiatric disorder, other than stable
             depression, within past ≤12 weeks

          -  history of HIV

          -  hypersensitivity or intolerance to inhaled beta-agonists, leukotriene antagonists,
             leukotriene synthesis inhibitors, or any of their ingredients, including lactose and
             galactose

          -  clinically unstable disease of the ophthalmologic, neurological, hepatic, renal,
             connective tissue, genitourinary, gastrointestinal, cardiovascular or hematologic
             systems

          -  current cancer or history (within past ≤5 years) of cancer (except for successfully
             treated basal and squamous cell carcinomas of the skin); if cancer-free for >5 years,
             study participation may be allowed

          -  evidence of uncontrolled hypertension