Efficacy and Safety Study to Compare Formoterol Fumerate in the Pressair DPI to the Foradil Aerolizer in Patient With Mild to Moderate Asthma

Summary

The purpose of this Phase II study is to evaluate efficacy and safety of inhaled formoterol fumarate in the Pressair DPI compared to the Foradil Aerolizer in patients with mild to moderate asthma. This study will include a screening visit followed by a 4 month treatment period.

Timeline

Start

2012-06

Primary completion

2013-02

Completion

2013-02

Outcome

Met primary endpoint

registry analysis (superiority or other test); Formoterol 12 μg vs Placebo; p <0.0001; Least squares mean difference 0.2242 (95% CI 0.1941 to 0.2544); Mixed Models Analysis NCT01641081 ↗

Drugs

Indications