Efficacy and Safety Comparison of Tiotropium Inhalation Solution (Respimat Inhaler) and Spiriva HandiHaler in Chronic Obstructive Pulmonary Disease (COPD)

A Randomised, Double-blind, Double-dummy, Placebo-controlled, Crossover Efficacy and Safety Comparison of 4-week Treatment Periods of Two Doses [5 μg (2 Actuations of 2.5 μg) and 10 μg (2 Actuations of 5 μg)] of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler, Tiotropium Inhalation Powder Capsule (18μg) Delivered by the HandiHaler in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Comparison of lung function response between tiotropium inhalation solution and Spiriva HandiHaler.

Inclusion Criteria:

• Diagnosis of COPD
• FEV1 < 60% predicted
• FEV1 < 70% of FVC
• Smoking history of 10 pack-years

Exclusion Criteria:

• Significant other disease than COPD
• Recent history of MI (1 year or less)
• Cardiac arrhythmia requiring drug therapy
• History of asthma, allergic rhinitis or eosinophil count > 600 mm3
• Symptomatic prostatic hypertrophy or bladder neck obstruction
• Known narrow-angle glaucoma
• Abnormal baseline hematology, blood chemistry or urinalysis
• History of cancer within last 5 years
• Life-threatening pulmonary obstruction
• Cystic fibrosis or bronchiectasis
• Tuberculosis
• Pulmonary resection