Tiotropium (18 Mcg) Once Daily Via the HandiHaler® in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Registration Number
- NCT00274547
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The primary objective of this trial is to determine whether treatment with tiotropium (18 mcg) capsule once daily via the HandiHaler reduces the proportion of patients with COPD experiencing an exacerbation and the proportion of patients hospitalized for an exacerbation during a six month observation period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Not specified
- Target Recruitment
- 1829
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Percentage of patients experiencing an exacerbation 6 months Percentage of patients hospitalized for a COPD exacerbation 6 months
- Secondary Outcome Measures
Name Time Method Number of unscheduled out-patient visits 6 months Time to first COPD exacerbation 6 months Total number of days of corticosteroids for an COPD exacerbation 6 months Total number of antibiotics for an COPD exacerbation 6 months Time to first hospitalization associated with an COPD exacerbation 6 months Total number of hospital admissions and total hospital days 6 months Trough post-dose FEV1 and FVC after 3 and 6 months 90 minute post-dose FEV1 and FVC after 3 and 6 months Occurrence of serious adverse events 6 months
Trial Locations
- Locations (13)
Boehringer Ingelheim Investigational Site
🇺🇸Salt Lake City, Utah, United States
Hampton VA Medical Center
🇺🇸Hampton, Virginia, United States
Carl T. Hayden VA Medical Center
🇺🇸Phoenix, Arizona, United States
Dallas VAMC
🇺🇸Dallas, Texas, United States
J. Hillis Miller Health Center
🇺🇸Gainesville, Florida, United States
4720 I-10 Service Road
🇺🇸Metairie, Louisiana, United States
Bronx VA Medical Center
🇺🇸New York, New York, United States
Hunter Holmes McGuire Medical Center
🇺🇸Richmond, Virginia, United States
Respiratory Diseases (111A)
🇺🇸Bay Pines, Florida, United States
Southern Arizona VA Health Care System
🇺🇸Tuscon, Arizona, United States
Veteran Affairs Medical Center
🇺🇸Minneapolis, Minnesota, United States
VA Long Beach Healthcare System
🇺🇸Long Beach, California, United States
Veterans Affairs Medical Center
🇺🇸Houston, Texas, United States