At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase-II, Randomized, Placebo-Controlled, Parallel-Group Clinical Trial to Study the Efficacy and Safety of MK-1029 in Adult Subjects With Persistent Asthma That is Uncontrolled While Receiving Montelukast.
In Brief
A Phase 2 clinical trial evaluating MK-1029 150 mg, MK-1029 Matching-image Placebo, and 2 other interventions for Asthma. Completed, enrolled 142 participants.
Detailed Summary
The purpose of this trial is to compare the safety, tolerability, and efficacy of adding MK-1029 to montelukast in adults with persistent asthma that is uncontrolled while receiving montelukast alone. Participants will have a specific genetic marker for clinical efficacy of MK-1029. The primary hypothesis is that when added to montelukast, treatment with MK-1029 is superior to placebo, as demonstrated by an increase in forced expiratory volume in one second (FEV1), measured as the average change from baseline at the end of Week 4 and Week 6 of treatment.
Study Details
Timeline
Interventions
150 mg tablet administered orally, once a day (QD), at bedtime
Matching-image placebo tablet administered orally, QD, at bedtime
10 mg tablet administered orally, QD, at bedtime
1 or 2 inhalations 4 times a day (QID) as needed (PRN) as a Rescue Medication