Conditions: Asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 576
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Participants receive MK-1029 10 mg tablets once daily (QD) for 12 weeks arm 2: Participants receive MK-1029 30 mg tablets QD for 12 weeks arm 3: Participants will receive MK-1029 two 30 mg tablets QD for 12 weeks arm 4: Participants will receive MK-1029 150 mg tablets QD for 12 weeks arm 5: Participants will receive Montelukast 10 mg tablets QD for 12 weeks arm 6: Participants will receive Placebo tablets QD for 12 weeks arm 7: Participants will receive either MK-1029 1 mg or 3 mg tablets (dose to be determined based on results of interim analysis from Part I) QD. arm 8: Participants will receive Montelukast 10 mg tablets QD and MK-1029 tablets (dose to be determined based on results of interim analysis from Part I) QD

Interventions: intervention 1: MK-1029 intervention 2: Montelukast 10 mg intervention 3: Placebo
Intervention descriptions: intervention 1: MK-1029 10 mg, 30 mg or 150 mg oral tablets taken QD at bedtime, based on randomization. intervention 2: Parts I-II: Participants will receive Montelukast 10 mg tablets QD intervention 3: Parts I-II: Participants will receive Placebo tablets QD

Protocol document: