At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy, Safety and Tolerability of Two Fixed-Dose Combinations of Aclidinium Bromide With Two Doses of Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo All Administered Twice Daily in Stable, Moderate to Severe Chronic Obstructive Pulmonary Disease Patients.
In Brief
A Phase 2 clinical trial evaluating Aclidinium 200 μg / formoterol 12 μg, Placebo, and 3 other interventions for Chronic Obstructive Pulmonary Disease. Completed, enrolled 176 participants across 10 sites in 2 countries.
Detailed Summary
The purpose of this multicenter, dose-ranging study is to compare two Fixed-Dose Combinations of aclidinium bromide and formoterol fumarate with placebo, aclidinium bromide and formoterol fumarate, all administered BID in patients with stable, moderate to severe COPD. Every treatment period is 14-days long and there is a 7-days wash-out period in between them. The trial starts with a run in phase of 10 to 17-days duration and it ends up with a follow up contact 14-days after last treatment dose.
Study Details
Timeline
Interventions
Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) twice daily
Placebo control twice daily
Formoterol fumarate 12 μg twice daily
Aclidinium bromide 200 μg twice daily
Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) twice daily