a dose-ranging study of mk-1029 in adults with persistent asthma (mk-1029-012)

Conditions: Asthma

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