Study to Evaluate the Effectiveness and Safety of MK-1029 in the Treatment of Persistent Asthma That is Not Controlled With Montelukast (ML) in Adults (MK-1029-011)
Condition: Asthma
MeSH terms: Asthma
Intervention: MK-1029; Placebo; Montelukast (ML)
Intervention description: MK-1029 150 mg tablets taken QD; Placebo tablets (matching the MK-1029 150 mg tablets) QD; ML 10 mg tablets QD
Intervention MeSH terms: Montelukast
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 107.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effect of MK-1029 on lung function in the
      treatment of adults who have persistent asthma that is uncontrolled with the use of
      montelukast (ML). Participants will use randomized study drug (either MK-1029 or placebo) for
      two separate 4-week treatment periods. All participants will also use ML during the treatment
      periods. The primary hypothesis is that MK-1029 is superior to placebo in change from
      baseline in forced expiratory volume in one second (FEV1) at the end of the 4-week treatment
      period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  not pregnant or breastfeeding and does not plan to become pregnant for the duration of
             the study;

          -  symptoms of persistent asthma for at least one year;

          -  current use of asthma treatments: 1) "as-needed" inhaled SABAs (albuterol/salbutamol)
             and no asthma controller for at least 4 weeks prior to Screening Visit OR 2) stable
             dose of ICS, combination ICS/LABA and/or oral asthma controller(s) for at least 4
             weeks prior to Screening Visit and able to tolerate discontinuing all controllers
             while receiving ML;

          -  no history of smoking OR no smoking for at least 1 year, with a smoking history of no
             more than 10 pack-years;

          -  able to maintain a constant day/night, awake/sleep cycle;

          -  agrees to not change habitual consumption of beverages or foods containing caffeine
             throughout the study;

          -  Body Mass Index (BMI) of 15 kg/m^2 to 40 kg/m^2.

        Exclusion Criteria:

          -  history of myocardial infarction, congestive heart failure, or uncontrolled cardiac
             arrhythmia within 3 months prior to Screening Visit;

          -  hospitalized or hospitalization within 4 weeks prior to Screening Visit;

          -  intention of moving or anticipation of missing any study visits;

          -  any major surgical procedure(s) within 4 weeks prior to Screening Visit;

          -  participation in a clinical trial involving an investigational drug within 4 weeks
             prior to Screening Visit;

          -  current regular use or a recent past abuse (within past 5 years) of alcohol (>14
             drinks/week) or illicit drugs;

          -  donation of a unit of blood within 2 weeks prior to Screening Visit or intention of
             donating a unit of blood during the study;

          -  evidence of another active pulmonary disorder such as bronchiectasis or COPD;

          -  treatment in an emergency room for asthma within 4 weeks prior to Screening Visit or
             hospitalization for asthma within 2 months prior to Screening Visit;

          -  respiratory tract infection which required treatment with antibiotics within 2 months
             prior to Screening Visit;

          -  evidence of active sinus disease within 1 week prior to Screening Visit;

          -  history of a psychiatric disorder, other than stable depression, within 3 months prior
             to Screening Visit;

          -  history of human immunodeficiency virus (HIV);

          -  hypersensitivity or intolerance to inhaled beta-agonists and/or leukotriene inhibitors
             or any of their ingredients, including lactose and galactose;

          -  unstable disease of the ophthalmologic, neurological, hepatic, renal, connective
             tissue, genitourinary, gastrointestinal, cardiovascular or hematologic systems;

          -  cancer (except for successfully treated basal and squamous cell carcinomas of the
             skin) or history of cancer within 5 years prior to Screening Visit;

          -  uncontrolled hypertension.