High Dose Trial in COPD

A Randomized, Multiple-dose, Double-Blind, Crossover Study to Compare the Efficacy and Safety of 200 μg and 400 μg of BEA 2180 BR to Tiotropium 5 μg and Placebo When Each is Delivered by the Respimat® Inhaler in Patients With Chronic Obstructive Pulmonary Disease (COPD)

The primary objective of this study was to compare the efficacy and safety of 200 μg and 400 μg of BEA 2180 BR to tiotropium 5 μg and placebo when each was delivered by the Respimat® Inhaler once daily for four weeks in patients with COPD.

1. Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 >=30% and <= 60% of predicted normal and FEV1 <=70% of FVC at the baseline PFTs at Visit 1 (at both timepoints).
2. All patients must have an increase in FEV1 of at least 12% from baseline (th e -10 minute measurement) 45 min after inhalation of 80 ?g Atrovent MDI.
3. Male or female patients 40 years of age or older.
4. Smoker or ex-smoker with a history of more than 10 pack years.

1. Patients with any other significant disease will be excluded. 2. Patients with a history of asthma or allergic rhinitis will be excluded.