Status:
COMPLETED
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)
Lead Sponsor:
AstraZeneca
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
The aim of the present study is to evaluate the 24h bronchodilatory efficacy of inhaled aclidinium bromide 400 µg administered twice a day versus placebo and tiotropium bromide, respectively, after 6 ...
Eligibility Criteria
Inclusion
- Adult male and female patients aged ≥40 with stable moderate to severe COPD (GOLD guidelines).
- Post-salbutamol (FEV1) \< 80% and ≥ 30% of predicted normal value and Post-salbutamol FEV1/FVC \< 70%.
- Current or ex-smokers of 10 ≥pack-years.
Exclusion
- Patients with no history or current diagnosis of asthma.
- No evidence of an exacerbation within 6 weeks prior to the screening visit.
- No evidence of clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities.
- No contraindication to use of anticholinergic drugs such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
414 Patients enrolled
Trial Details
Trial ID
NCT01462929
Start Date
November 1 2011
End Date
May 1 2012
Last Update
January 4 2017
Active Locations (41)
Enter a location and click search to find clinical trials sorted by distance.
1
Almirall Investigational Site #9
Humpolec, Czechia, 396 26
2
Almirall Investigational Site #1
Jaroměř, Czechia, 551 01
3
Almirall Investigational Site #3
Mělník, Czechia, 276 01
4
Almirall Investigational Site #4
Berlin, Germany, 10117