NCT00274547CompletedPhase 3
A Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Assessing the Proportion of Patients Experiencing an Exacerbation and Proportion of Patients Hospitalized for an Exacerbation Over 6 Months During Treatment With Tiotropium 18 Mcg Capsule Once Daily in Patients With COPD in a Veterans Affairs Setting
Boehringer Ingelheim26 sites in 1 country1,829 target enrollmentStarted: September 2001Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 1,829
- Locations
- 26
- Primary Endpoint
- Percentage of patients experiencing an exacerbation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Percentage of patients experiencing an exacerbation
Time Frame: 6 months
Percentage of patients hospitalized for a COPD exacerbation
Time Frame: 6 months
Secondary Outcomes
- 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 hospital admissions and total hospital days(6 months)
- Time to first hospitalization associated with an COPD exacerbation(6 months)
- Total number of antibiotics for an COPD exacerbation(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)
Investigators
Study Sites (26)
Loading locations...
Similar Trials
Completed
Phase 3
Evaluation of the Long- Term Effects of Spiriva on Lung Function in COPD PatientsPulmonary Disease, Chronic ObstructiveNCT00144339Boehringer Ingelheim5,993
Completed
Phase 2
An Efficacy and Safety Evaluation of Tiotropium add-on Therapy in Patients With Severe Persistent AsthmaAsthmaNCT00365560Boehringer Ingelheim115
Completed
Phase 2
Efficacy and Safety of 3 Doses of Tiotropium Compared to Placebo in Adolescents (12 to 17 Yrs) With Moderate AsthmaAsthmaNCT01122680Boehringer Ingelheim105
Completed
Phase 4
Efficacy of Tiotropium in Patients of African Descent With Chronic Obstructive Pulmonary DiseasePulmonary Disease, Chronic ObstructiveNCT00106821Boehringer Ingelheim166
Completed
Phase 4
Efficacy and Safety of Tiotropium in Patients With COPD and Concomitant Diagnosis of AsthmaPulmonary Disease, Chronic ObstructiveAsthmaNCT00152984Boehringer Ingelheim472