Efficacy and Safety of Aclidinium Bromide 400 µg Compared to Placebo and to Tiotropium Bromide in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the present study is to evaluate the 24h bronchodilatory efficacy of inhaled aclidinium bromide 400 µg administered twice a day versus placebo and tiotropium bromide, respectively, after 6 weeks of treatment.

• Phase: Phase 3
• 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.