At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II, Randomized, Placebo-controlled, Double-blind, Double-dummy, 5-period Complete Crossover Study of the Bronchodilator Effects of Formoterol Fumarate Inhalation Powder in Patients With Mild to Moderate Asthma.
In Brief
A Phase 2 clinical trial evaluating Formoterol Fumarate in the Pressair DPI, Low Dose, Formoterol Fumarate in the Pressair DPI, High Dose, and 3 other interventions for Asthma. Completed, enrolled 174 participants across 29 sites.
Detailed 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.
Study Details
Timeline
Interventions
Formoterol Fumarate in the Pressair DPI 6 micrograms, twice a day for 14 days
Formoterol Fumarate in the Pressair DPI 12 micrograms, twice a day for 14 days
Foradil Aerolizer 12 micrograms, twice a day for 14 days
Foradil Aerolizer 24 micrograms, twice per day for 14 days
Placebo in the Pressair for 14 days