Efficacy and safety of aclidinium bromide at two dose levels versus placebo administered in chronic obstructive pulmonary disease (COPD) patients
Study identifier:M/34273/34
ClinicalTrials.gov identifier:NCT01001494
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
Efficacy and safety of aclidinium bromide at two dose levels vs placebo when administered to patients with moderate to severe chronic obstructive pulmonary disease (COPD)
Medical condition
Chronic obstructive pulmonary disease (COPD)
Phase
Phase 3
Healthy volunteers
No
Study drug
Aclidinium bromide 200 μg bid, Aclidinium bromide 400 μg bid, Placebo
Sex
All
Actual Enrollment
828
Study type
Interventional
Age
40 Years +
Date
Study Start Date: 01 Oct 2009
Primary Completion Date: 01 Nov 2010
Study Completion Date: 01 Nov 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: Aclidinium bromide 200 μg bid Aclidinium bromide 200 μg twice-daily via inhalation | Drug: Aclidinium bromide 200 μg bid Aclidinium bromide 200 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 24 weeks |
| Experimental: Aclidininum bromide 400 μg bid Aclidinium bromide 400 μg twice-daily via inhalation | Drug: Aclidinium bromide 400 μg bid Aclidinium bromide 400 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 24 weeks |
| Placebo Comparator: Placebo Placebo | Drug: Placebo Placebo twice-daily by inhalation for 24 weeks |
Contacts
Investigators
Principal Investigator
Esther Garcia
AstraZeneca
