Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD Bronchitis Chronic Emphysema
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2443
Healthy volunteers: no

Brief 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).

Detailed description:
This Phase III study seeks to confirm the long-term bronchodilator efficacy and effects on COPD related health status and other secondary parameters as well as the safety of two doses of the combination of aclidinium bromide/formoterol FDC (FDC 400/12 μg and 400/6 μg) compared with aclidinium bromide monotherapy 400 μg, formoterol monotherapy 12 μg and placebo.

Arms:
arm 1: 24 week, double blind treatment period arm 2: 24 week, double blind treatment period arm 3: 24 week, double blind treatment period arm 4: 24 week, double blind treatment period arm 5: 24 week, double blind treatment period

Interventions: intervention 1: Aclidinium Bromide/Formoterol Fumarate intervention 2: Aclidinium Bromide/Formoterol Fumarate intervention 3: Aclidinium Bromide intervention 4: Placebo intervention 5: Formoterol Fumarate
Intervention descriptions: intervention 1: Inhaled Aclidinium/formoterol Fixed Dose Combination (FDC) low dose (400/6 μg), twice per day intervention 2: Inhaled Aclidinium/formoterol FDC high dose (400/12 μg), twice per day intervention 3: Inhaled Aclidinium 400 μg, twice per day intervention 4: Inhaled dose-matched placebo, twice per day intervention 5: Inhaled Formoterol 12 μg, twice per day

Protocol document: