Clinical trial to assess rate of onset of bronchodilator action in severe stable chronic obstructive pulmonary disease (COPD) patients
Study identifier:M/34273/24
ClinicalTrials.gov identifier:NCT00435760
EudraCT identifier:2005-005804-17
CTIS identifier:N/A
Study Complete
Official Title
Single dose, double-blind, double-dummy, 3 period cross-over, placebo controlled clinical trial to assess the reate of onset of action of inhaled aclidinium bromide 200µg compared to placebo and Tiotropium 18µg in patients with chronic obstructive pulmonary disease (COPD).
Medical condition
Chronic obstructive pulmonary disease (COPD)
Phase
Phase 3
Healthy volunteers
No
Study drug
Aclidinium bromide, Placebo Tiotropium, Tiotropium, Placebo LAS34273
Sex
All
Actual Enrollment
115
Study type
Interventional
Age
40 Years +
Date
Study Start Date: 01 Feb 2007
Primary Completion Date: 01 Aug 2007
Study Completion Date: 01 Aug 2007
Study design
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover 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 |
|---|---|
| Active Comparator: Tiotropium 1 puff, 1 day treatment | Drug: Tiotropium 1 puff of 18 µg (22.5 µg tiotropium bromide monohydrate) in the morning between 8:00 and 10:00 |
| Placebo Comparator: Placebo Tiotropium or Aclidinium Placebo, 1 day treatment | Drug: Placebo Tiotropium 1 puff once daily, 1 day treatment Drug: Placebo LAS34273 1 puff, 1 dat treatment |
| Experimental: Aclidinium bromide 200 micrograms, once daily, 1 day treatment | Drug: Aclidinium bromide 200 micrograms, once daily, 1 day treatment |
Contacts
Investigators
Principal Investigator
Esther Garcia
AstraZeneca
