At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Long-term, Randomized, Double-blind, Extension Study of the Efficacy, Safety, and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28- 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 Fixed-Dose Combination (FDC), Aclidinium bromide, and 2 other interventions for Chronic Obstructive Pulmonary Disease. Completed, enrolled 921 participants across 208 sites in 4 countries.
Detailed Summary
The purpose of this Phase III study is to evaluate the long-term safety and tolerability of two fixed-dose combinations of inhaled aclidinium bromide/formoterol fumarate, aclidinium bromide, formoterol fumarate and placebo in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). Long-term efficacy, pharmacoeconomic and health-related quality of life assessments will also be evaluated. This extension study will include a 28 week treatment period, followed by a four week follow up visit. All patients will remain in the same treatment group as for the lead-in study and continue on one of the four treatment arms or placebo.
Study Details
Timeline
Interventions
Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) high dose, twice per day
Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) low dose, twice per day
Inhaled Aclidinium bromide 400 μg, twice per day
Inhaled Formoterol Fumarate 12 μg, twice per day
Inhaled dose-matched placebo, twice per day