At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Randomized, Double-blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo for 24- Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD).
In Brief
A Phase 3 clinical trial evaluating Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, and 2 other interventions for Chronic Obstructive Pulmonary Disease. Completed, enrolled 1,692 participants across 222 sites in 4 countries.
Detailed Summary
The purpose of this Phase III study is to assess the maintenance bronchodilator effects of the fixed dose combination versus monotherapies. This study will also assess the effects of the fixed dose combination in terms of COPD symptoms, disease related health status and the long-term safety and tolerability of the fixed dose combination. This study will include a 24 week treatment period, preceding by a run-in period, followed by a two week follow up visit. All patients will be randomized to one of four treatment arms or placebo.
Study Details
Timeline
Interventions
Inhaled Aclidinium/formoterol FDC 400/12μg, twice per day
Inhaled Aclidinium/formoterol FDC 400/6μg, twice per day
Inhaled Aclidinium 400 μg, twice per day
Inhaled Formoterol 12 μg, twice per day
Inhaled dose-matched placebo, twice per day