Status:
COMPLETED
Efficacy and Safety (Including 24-hour Holter Monitoring) of Tiotropium Inhalation Capsules in Patients With COPD
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT00239460
Start Date
July 1 2003
Last Update
November 1 2013
Active Locations (12)
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1
Attn: William C. Bailey, M.D.
Birmingham, Alabama, United States
2
Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
3
Olive View UCLA Medical Center
Sylmar, California, United States
4
Rocky Mountain Center for Clinical Research
Wheat Ridge, Colorado, United States