Long-term extension study of the safety, tolerability, and efficacy of aclidinium bromide in patients with moderate to severe chronic obstructive pulmonary disease (COPD) (LAS-MD-36)
Study identifier:LAS-MD-36
ClinicalTrials.gov identifier:NCT00970268
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A long-term, randomized, double-blind extension study of the safety, tolerability, and efficacy of aclidinium bromide at two dose levels when administered to patients with moderate to severe chronic obstructive pulmonary disease
Medical condition
Chronic Obstructive Pulmonary Disease
Phase
Phase 3
Healthy volunteers
No
Study drug
Aclidinium bromide
Sex
All
Actual Enrollment
291
Study type
Interventional
Age
40 Years +
Date
Study Start Date: 01 Aug 2009
Primary Completion Date: 01 Oct 2010
Study Completion Date: 01 Oct 2010
Study design
Allocation: Randomized
Endpoint Classification: Safety/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 52 weeks of treatment | Drug: Aclidinium bromide Aclidinium bromide 200 μg, oral inhalation twice per day for 52 weeks of treatment |
| Experimental: 2 Aclidinium bromide dose, inhaled, for 52 weeks of treatment | Drug: Aclidinium bromide Aclidinium bromide 400 μg, oral inhalation twice per day for 52 weeks of treatment |
Contacts
Investigators
Principal Investigator
Esther Garcia
AstraZeneca
