drugset / Trial / NCT02720081
Study of MK-1029 in Participants With Persistent Asthma That Cannot Be Controlled With Montelukast (MK-1029-015)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |