Triple in Asthma Dose Finding

Summary

Primary objective The primary objective was to evaluate the efficacy of a free combination of CHF 5259 at 3 dose levels plus Foster® 100/6 μg in a pMDI by comparison with Foster® 100/6 μg in terms of forced expiratory volume in the first second (FEV1) area under the curve between time 0 and 12 hours (AUC0-12h) normalised by time on Day 42. Key secondary objective The key secondary objective was to evaluate the efficacy of the free combination CHF 5259 plus Foster® 100/6 μg by comparison with Foster® 100/6 μg in terms of peak FEV1 on Day 42. Secondary objectives The secondary objectives were: * To evaluate the effect of the free combination of CHF 5259 plus Foster® 100/6 μg on other lung function parameters and on clinical outcome measures; * To assess the safety and the tolerability of the study treatments.

Timeline

Start

2014-04-11

Primary completion

2015-03-08

Completion

2015-03-08

Drugs

Indications