Status:
COMPLETED
Efficacy and Safety of Aclidinium Bromide at Two Dose Levels Versus Placebo Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients
Lead Sponsor:
AstraZeneca
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
The main purpose of this study is to assess the long term bronchodilator efficacy, safety and tolerability of inhaled aclidinium bromide at two dose levels compared to placebo in COPD patients and the...
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 :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
828 Patients enrolled
Trial Details
Trial ID
NCT01001494
Start Date
October 1 2009
End Date
November 1 2010
Last Update
January 4 2017
Active Locations (106)
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1
Almirall Investigational Sites#4
Benešov, Czechia, 256 01
2
Almirall Investigational Sites#9
Jaroměř, Czechia, 55 101
3
Almirall Investigational Sites#3
Liberec, Czechia, 460 01
4
Almirall Investigational Sites#2
Lovosice, Czechia, 410 02