Efficacy and Safety (Including 24-hour Holter Monitoring) of Tiotropium Inhalation Capsules in Patients With COPD
Status and phase
Completed
Phase 3
Conditions
Pulmonary Disease, Chronic Obstructive
Treatments
Drug: Tiotropium
Details and patient eligibility
About
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.
Sex
All
Ages
40+ years old
Volunteers
No Healthy Volunteers
Inclusion and exclusion 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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
Trial contacts and locations
12
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Data sourced from clinicaltrials.gov
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