At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Fixed-dose Combinations Compared With Individual Components and Placebo When Administered to Patients With Stable Chronic Obstructive Pulmonary Disease.
In Brief
A Phase 3 clinical trial evaluating Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, and 2 other interventions for Chronic Obstructive Pulmonary Disease (COPD). Completed, enrolled 2,443 participants across 197 sites in 22 countries.
Detailed Summary
The objective is to provide data supporting the use of LAS40464 as an efficacious and safe maintenance bronchodilator treatment of patients with Chronic Obstructive Pulmonary Disease (COPD).
Study Details
Timeline
Interventions
Inhaled Aclidinium/formoterol Fixed Dose Combination (FDC) low dose (400/6 μg), twice per day
Inhaled Aclidinium/formoterol FDC high dose (400/12 μg), twice per day
Inhaled Aclidinium 400 μg, twice per day
Inhaled dose-matched placebo, twice per day
Inhaled Formoterol 12 μg, twice per day