Efficacy and safety of aclidinium bromide for treatment of moderate to severe chronic obstructive pulmonary disease (COPD) (LAS-MD-33)
Study identifier:LAS-MD-33
ClinicalTrials.gov identifier:NCT00891462
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
Efficacy and Safety of Aclidinium Bromide at Two Dose Levels (200 μg Twice Daily, 400 μg Twice Daily) vs. Placebo When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Medical condition
Chronic Obstructive Pulmonary Disease
Phase
Phase 3
Healthy volunteers
No
Study drug
Aclidinium bromide, Placebo
Sex
All
Actual Enrollment
561
Study type
Interventional
Age
40 Years +
Date
Study Start Date: 01 Apr 2009
Primary Completion Date: 01 Nov 2009
Study Completion Date: 01 Nov 2009
Study design
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2016 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 Aclidinium bromide dose, inhaled, for 12 weeks of treatment | Drug: Aclidinium bromide Aclidinium bromide 200 μg, oral inhalation twice per day for 12 weeks of treatment |
| Experimental: 2 Aclidinium bromide dose, inhaled, for 12 weeks of treatment | Drug: Aclidinium bromide Aclidinium bromide 400 μg, oral inhalation twice per day for 12 weeks of treatment |
| Placebo Comparator: 3 Inhaled placebo for 12 weeks | Drug: Placebo Dose-matched placebo, oral inhalation twice per day for 12 weeks of treatment |
Contacts
Investigators
Principal Investigator
Esther Garcia
AstraZeneca
