Status:
COMPLETED
Tiotropium / Respimat One-Year Study
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
To evaluate the long term effects of treatment with two doses of Tiotropium delivered by the Respimat inhaler in patients with COPD.
Eligibility Criteria
Inclusion
- Criteria
- Patients with stable moderate to severe COPD and a smoking history of at least 10 pack years were eligible for inclusion in the study. Patients with significant diseases other than COPD were excluded as were patients with a recent history of myocardial infarction, history of malignancy, unstable or life-threatening cardiac arrhythmia, narrow-angle glaucoma, asthma or other allergic conditions. Patients treated with cromolyn, nedocromil, oral beta-adrenergics or unstable doses of oral corticosteroids were ineligible for inclusion in the study as were patients who had received previous treatment with tiotropium.
Exclusion
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
1007 Patients enrolled
Trial Details
Trial ID
NCT00168831
Start Date
February 1 2003
Last Update
May 20 2014
Active Locations (76)
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1
Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
2
Boehringer Ingelheim Investigational Site
La Jolla, California, United States
3
Boehringer Ingelheim Investigational Site
Long Beach, California, United States
4
Boehringer Ingelheim Investigational Site
San Luis Obispo, California, United States