Clinical Trial to Assess Rate of Onset of Bronchodilator Action in Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients

Single Dose, Double-blind, Double-dummy, 3 Period Cross-over, Placebo Controlled Clinical Trial to Assess the Reate of Onset of Action of Inhaled Aclidinium Bromide 200µg Compared to Placebo and Tiotropium 18µg in Patients With Chronic Obstructive Pulmonary Disease (COPD).

This trial evaluates the rate of onset of bronchodilator action of aclidinium bromide compared to placebo and tiotropium in patients with severe COPD after a single dose treatment.

This is a single dose, randomised, double-blind, double-dummy, 3 period cross-over, placebo controlled, multinational, multicentre trial.

Inclusion Criteria:

• Males and females aged ≥ 40 years
• Current or ex-smokers of ≥ 10 pack-year
• Clinical diagnosis of severe stable COPD

Exclusion Criteria:

• History or current diagnosis of asthma, allergic rhinitis, or atopy
• Respiratory tract infection or acute COPD exacerbation in the last 6 weeks
• Hospitalised for an acute COPD exacerbation in the last 3 months
• Evidence of contraindicated use of anticholinergic drugs