Efficacy and Safety (Including 24-hour Holter Monitoring) of Tiotropium Inhalation Capsules in Patients With COPD
Phase 3
Completed
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Registration Number
- NCT00239460
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 196
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 Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Trough FEV1 after 12 weeks of treatment 12 weeks
- Secondary Outcome Measures
Name Time Method Vital signs week 8 and week 12 Trough FEV1 at Visit 3 week 8 Trough FVC at Visits 3 and 4 week 8 and week 12 24-hour holter ECG monitoring week 8 and week 12 FEV1 and FVC 90 min post study drug inhalation at all visits 90 minutes post-medication Use of rescue medication 12 weeks Patient's Global Evaluation week 8 and week 12 Physician's Global Evaluation week 8 and week 12 Adverse events 12 weeks Physical Exam week 12 12-lead ECG week 8 and week 12 Health Related Quality of Life assessed by the EQ5D at Visit 2 and 4 week 8 and week 12
Trial Locations
- Locations (8)
Attn: William C. Bailey, M.D.
🇺🇸Birmingham, Alabama, United States
Boehringer Ingelheim Investigational Site
🇺🇸Houston, Texas, United States
The Oregon Clinic
🇺🇸Portland, Oregon, United States
Olive View UCLA Medical Center
🇺🇸Sylmar, California, United States
Rocky Mountain Center for Clinical Research
🇺🇸Wheat Ridge, Colorado, United States
LSU Health Sciences Center
🇺🇸Shreveport, Louisiana, United States
Pulmonary and Critical Care Services, PC
🇺🇸Albany, New York, United States
Respiratory Diseases (111A)
🇺🇸Bay Pines, Florida, United States