Efficacy and Safety (Including 24-hour Holter Monitoring) of Tiotropium Inhalation Capsules in Patients With COPD

Completed · Phase 3

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

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.

Key facts

Study ID

NCT00239460

Run by

Boehringer Ingelheim

People needed

196

Starts

2003-07-01

Last updated by the study team

2013-11-01

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Attn: William C. Bailey, M.D. — Birmingham, Alabama, United States
• Boehringer Ingelheim Investigational Site — Phoenix, Arizona, United States
• Olive View UCLA Medical Center — Sylmar, California, United States
• Rocky Mountain Center for Clinical Research — Wheat Ridge, Colorado, United States
• Respiratory Diseases (111A) — Bay Pines, Florida, United States
• Boehringer Ingelheim Investigational Site — Pembroke Pines, Florida, United States
• Boehringer Ingelheim Investigational Site — Coeur d'Alene, Idaho, United States
• LSU Health Sciences Center — Shreveport, Louisiana, United States
• Pulmonary and Critical Care Services, PC — Albany, New York, United States
• The Oregon Clinic — Portland, Oregon, United States
• Boehringer Ingelheim Investigational Site — Charleston, South Carolina, United States
• Boehringer Ingelheim Investigational Site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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