Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD Chronic Obstructive Pulmonary Disease Chronic Bronchitis Emphysema Airflow Obstruction, Chronic Chronic Airflow Obstruction Chronic Obstructive Airway Disease Chronic Obstructive Lung Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 921
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) high dose arm 2: Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) low dose arm 3: Aclidinium bromide 400 μg arm 4: Formoterol Fumarate 12 μg arm 5: Placebo

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

Protocol document: