Pulmonary Disease, Chronic Obstructive
Conditions
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.
Interventions
DRUGTiotropium
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Trough FEV1 after 12 weeks of treatment | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Trough FVC at Visits 3 and 4 | 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 |
| Trough FEV1 at Visit 3 | week 8 |
| Adverse events | 12 weeks |
| Vital signs | week 8 and week 12 |
| Physical Exam | week 12 |
| 12-lead ECG | week 8 and week 12 |
| 24-hour holter ECG monitoring | week 8 and week 12 |
| Health Related Quality of Life assessed by the EQ5D at Visit 2 and 4 | week 8 and week 12 |
Countries
United States
Outcome results
None listed