Efficacy and Safety of Aclidinium Bromide at Two Dose Levels Versus Placebo Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

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 benefits of the product in disease-related health status, COPD symptoms and COPD exacerbations.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Bromides

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.