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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Tiotropium Bromide

Criteria

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