Status:
COMPLETED
Efficacy and Safety of Aclidinium Bromide 400 µg BID (Twice a Day)Compared to Placebo 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 effect of aclidinium bromide 400 μg twice a day (BID) administered twice a day versus placebo on exercise endurance and on hyperinflation and dyspnoea a...
Eligibility Criteria
Inclusion
- Adult male and female patients aged ≥ 40 with stable moderate to severe COPD (Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines).
- Post-salbutamol Forced Expiratory Volume in one second(FEV1) \< 80% and ≥ 30% of predicted normal value and Post-salbutamol FEV1/Forced Vital Capacity (FVC) \< 70%.
- Current or ex-smokers of ≥ 10 pack-years
- Functional residual capacity (FRC) measured by body plethysmography at Screening Visit ≥ 120% of predicted value
Exclusion
- History or current diagnosis of asthma
- Signs of an exacerbation within 6 weeks ( or 3 months if results in hospitalisation) prior to the screening visit or during the run-in period.
- Clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities.
- Conditions where the use of anticholinergic drugs is contraindicated, such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.
- Patients with an oxygen saturation \< 85% during cycle exercise on room air at Screening Visit, Run- in Visit and Visit 1.
- Contra-indications of cardiopulmonary exercise testing.
- Patient who in the investigator's opinion will need to start a pulmonary rehabilitation program during the study and/or patients who have just started/finished pulmonary rehabilitation at least 3 months prior to the Screening Visit.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT01471171
Start Date
November 1 2011
End Date
June 1 2012
Last Update
January 4 2017
Active Locations (14)
Enter a location and click search to find clinical trials sorted by distance.
1
Almirall Investigational Site #10
Berlin, Germany, 10117
2
Almirall Investigational Site #6
Berlin, Germany, 10117
3
Almirall Investigational Site #2
Berlin, Germany, 14050
4
Almirall Investigational Site #4
Frankfurt, Germany, 60596