Roflumilast Plus Montelukast in Adults With Severe Asthma

Summary

This study will evaluate the effect of roflumilast 500 μg once daily (QD) plus montelukast 10 mg QD versus 10 mg montelukast QD alone on predose (trough) prebronchodilator forced expiratory volume in the first second (FEV1).

Timeline

Start

2013-02

Primary completion

2013-10

Completion

2013-10

Outcome

Met primary endpoint

registry analysis (superiority or other test); Roflumilast Plus Montelukast vs Placebo Plus Montelukast; p = 0.013 NCT01765192 ↗

Drugs

Indications