Efficacy and safety of aclidinium bromide 400 µg compared to placebo and to tiotropium bromide in patients with stable moderate to severe chronic obstructive pulmonary disease (COPD)
Study identifier:M/34273/39
ClinicalTrials.gov identifier:NCT01462929
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A multiple dose, double-blind, double-dummy, placebo controlled, parallel clinical trial to assess the efficacy and safety of twice daily inhaled aclidinium bromide 400 µg compared to placebo and to tiotropium bromide in patients with stable 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, Tiotropium, Placebo
Sex
All
Actual Enrollment
414
Study type
Interventional
Age
40 Years +
Date
Study Start Date: 01 Nov 2011
Primary Completion Date: 01 Mar 2012
Study Completion Date: 01 May 2012
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Oct 2016 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Aclidinium bromide Aclidinium bromide 400 µg administered twice per day during 6 weeks of treatment | Drug: Aclidinium bromide Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) |
| Active Comparator: Tiotropium Tiotropium bromide 18 µg administered once per day during 6 weeks of treatment | Drug: Tiotropium Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h) |
| Placebo Comparator: Placebo Placebo comparator administered during 6 weeks of treatment | Drug: Placebo Dosage form: Dry powder Route of administration: Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h). |
Contacts
Investigators
Principal Investigator
Esther Garcia
AstraZeneca
