Study identifier:LAC-MD-36
ClinicalTrials.gov identifier:NCT01572792
EudraCT identifier:N/A
CTIS identifier:N/A
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)
Chronic Obstructive Pulmonary Disease
Phase 3
No
Aclidinium bromide/formoterol Fixed-Dose Combination (FDC), Aclidinium bromide, Formoterol Fumarate, Placebo
All
921
Interventional
40 Years +
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Feb 2017 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: 1 Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) high dose | Drug: Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) high dose, twice per day |
Experimental: 2 Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) low dose | Drug: Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) low dose, twice per day |
Active Comparator: 3 Aclidinium bromide 400 μg | Drug: Aclidinium bromide Inhaled Aclidinium bromide 400 μg, twice per day |
Active Comparator: 4 Formoterol Fumarate 12 μg | Drug: Formoterol Fumarate Inhaled Formoterol Fumarate 12 μg, twice per day |
Placebo Comparator: 5 Placebo | Drug: Placebo Inhaled dose-matched placebo, twice per day |