CompletedInterventionalPhase 2Updated Feb 28, 2017
Efficacy of Aclidinium Bromide Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients | NCT00868231 | Trialant
CompletedInterventionalPhase 2Updated Jan 4, 2017
Efficacy of Aclidinium Bromide Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients
ClinicalTrials.gov ID
NCT00868231
Lead Sponsor
AstraZenecaINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 2
Enrollment
30Actual
Last Update Posted
Jan 4, 2017Estimated
Start Date
Mar 2009
Primary Completion Date
Jul 2009Actual
Completion Date
Jul 2009Actual
Brief Summary
The main purpose of this study is to evaluate the efficacy, safety and tolerability of multiple doses of inhaled aclidinium bromide in moderate to severe COPD patients.
Chronic Obstructive Pulmonary Disease (COPD)
Aclidinium bromide 400 μg bid
Tiotropium 18 μg once-daily
Placebo
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.