Efficacy of Aclidinium Bromide Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Bromides; Tiotropium Bromide

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.