drugset / Trial / NCT02720081

Study of MK-1029 in Participants With Persistent Asthma That Cannot Be Controlled With Montelukast (MK-1029-015)

NCT02720081

Phase 2 Completed 142 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2016-05-11
Primary completion
2017-08-16
Completion
2017-09-06

Drugs

EvaluationDrugModalityDoseRoute
Subject MK-1029 Unknown 150 mg Oral
Background Montelukast Other / unclassified 10 mg Oral
Background Salbutamol Unknown 90 ug Inhaled
Background Salbutamol Unknown 100 ug Inhaled

Indications