Efficacy and Safety (Including 24-hour Holter Monitoring) of Tiotropium Inhalation Capsules in Patients With COPD

Efficacy and Safety (Including 24-hour Holter Monitoring) of Tiotropium Inhalation Capsules in Patients With Chronic Obstructive Pulmonary Disease (a 12-week, Parallel Group, Randomized, Placebo-cotrolled, Double-blind Study).

The objective of this study is to evaluate the effect of inhaled tiotropium bromide on trough FEV1 and to assess the cardiac effects through 12-lead and Holter ECG monitoring in patients with COPD.

Inclusion Criteria:

• History of COPD, FEV1 less than or equal to 65%, FEV1/FVC less than or equal 70%
• Smoking history greater than or equal to 10 pack years
• Not history of clinical diagnosis of asthma and/or atopy
• A history of thoracotomy with pulmonary resection
• Patients requiring the use of supplemental oxygen therapy for >12 hours per day
• Chronic use of systemic corticosteroids in an unstable daily dose
• Patients with a recent history of myocardial infarction
• A known hypersensitivity to anticholinergic drugs