Efficacy and Safety (Including 24-hour Holter Monitoring) of Tiotropium Inhalation Capsules in Patients With Chronic Obstructive Pulmonary Disease (a 12-week, Parallel Group, Randomized, Placebo-cotrolled, Double-blind Study).
- NCT00239460
- PHASE3
- INTERVENTIONAL
Last updated: 2013-11-01
Purpose of Trial
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.
This study is for people with
Pulmonary Disease, Chronic Obstructive
Interventions being studied
Tiotropium
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
ELIGIBILITY
Gender: ALL
Age: 40+
Healthy Volunteers: No
12 Locations
Birmingham
Attn: William C. Bailey, M.D.
Alabama, United States
Phoenix
Boehringer Ingelheim Investigational Site
Arizona, United States
Sylmar
Olive View UCLA Medical Center
California, United States
Wheat Ridge
Rocky Mountain Center for Clinical Research
Colorado, United States
Bay Pines
Respiratory Diseases (111A)
Florida, United States
Pembroke Pines
Boehringer Ingelheim Investigational Site
Florida, United States
Coeur d' Alene
Boehringer Ingelheim Investigational Site
Idaho, United States
Shreveport
LSU Health Sciences Center
Louisiana, United States
Albany
Pulmonary and Critical Care Services, PC
New York, United States
Portland
The Oregon Clinic
Oregon, United States
Charleston
Boehringer Ingelheim Investigational Site
South Carolina, United States
Houston
Boehringer Ingelheim Investigational Site
Texas, United States
Primary Contact(s)
Boehringer Ingelheim
Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Learn more at
ClinicalTrials.gov