Conditions: Asthma
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 107
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Participants received 4 weeks treatment with MK-1029 150 mg once daily (QD) + ML 10 mg QD in Period III and Placebo QD + ML 10 mg QD in Period V. Period IV was a 4-week wash-out period during which participants received single-blind Placebo QD and open-label ML 10 mg QD. arm 2: Participants received 4 weeks treatment with Placebo QD + ML 10 mg QD in Period III and MK-1029 150 mg QD + ML 10 mg QD in Period V. Period IV was a 4-week wash-out period during which participants received single-blind Placebo QD and open-label ML 10 mg QD.

Interventions: intervention 1: MK-1029 intervention 2: Placebo intervention 3: Montelukast (ML)
Intervention descriptions: intervention 1: MK-1029 150 mg tablets taken QD intervention 2: Placebo tablets (matching the MK-1029 150 mg tablets) QD intervention 3: ML 10 mg tablets QD

Protocol document: