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)

Conditions: Asthma

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.