Study identifier:LAC-MD-31
ClinicalTrials.gov identifier:NCT01437397
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase III, Randomized, Double-blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo for 24- Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD).
Chronic Obstructive Pulmonary Disease
Phase 3
No
Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate, Placebo
All
1692
Interventional
40 Years +
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Jan 2017 by AstraZeneca
AstraZeneca
-
The purpose of this Phase III study is to assess the maintenance bronchodilator effects of the fixed dose combination versus monotherapies. This study will also assess the effects of the fixed dose combination in terms of COPD symptoms, disease related health status and the long-term safety and tolerability of the fixed dose combination. This study will include a 24 week treatment period, preceding by a run-in period, followed by a two week follow up visit. All patients will be randomized to one of four treatment arms or placebo.
Location
Location
Anniston, AL, United States, 36207
Location
Athens, AL, United States, 35611
Location
Birmingham, AL, United States, 35209
Location
BIRMINGHAM, AL, United States, 35209
Location
Birmingham, AL, United States, 35216
Location
Florence, AL, United States, 35630
Location
Gulf Shores, AL, United States, 36542
Location
Jasper, AL, United States, 35501
Arms | Assigned Interventions |
---|---|
Experimental: 1 Aclidinium/formoterol Fixed Dose Combination (FDC) 400/12μg | Drug: Aclidinium Bromide/Formoterol Fumarate Inhaled Aclidinium/formoterol FDC 400/12μg, twice per day |
Experimental: 2 Aclidinium/formoterol Fixed Dose Combination (FDC) 400/6μg | Drug: Aclidinium Bromide/Formoterol Fumarate Inhaled Aclidinium/formoterol FDC 400/6μg, twice per day |
Active Comparator: 3 Aclidinium monotherapy 400 μg | Drug: Aclidinium Bromide Inhaled Aclidinium 400 μg, twice per day |
Active Comparator: 4 Formoterol monotherapy 12 μg | Drug: Formoterol Fumarate Inhaled Formoterol 12 μg, twice per day |
Placebo Comparator: 5 Placebo | Drug: Placebo Inhaled dose-matched placebo, twice per day |
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