Status:
COMPLETED
Effect of Tiotropium Inhalation Capsules (Spiriva) on Exercise Tolerance in COPD Patients
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40-80 years
Phase:
PHASE3
Brief Summary
The objective of this trial is to determine whether tiotropium inhalation capsules (Spiriva, Bromuro de Tiotropio), compared to placebo, enhances the improvement in exercise tolerance seen in patients...
Detailed Description
This is an 25-week multicenter, single country, randomised, double-blind, placebo-controlled, parallel group study to compare the efficacy of tiotropium inhalation capsules (Spiriva, Bromuro de Tiotro...
Eligibility Criteria
Inclusion
- COPD patients with FEV1 less 60% of predicted FEV1 less 70% of FVC.
Exclusion
- Patients with any respiratory infection in the six weeks prior to the Screening Visit or during the run-in period (between Visits 1 and 2).
- Patients with a recent history (i.e., 6 months - or less) of myocardial infarction.
- Patients with any cardiac arrhythmia requiring drug therapy in the past year or who have been hospitalized for heart failure within the past three years.
- Patients with symptomatic benign prostatic hypertrophy or bladder neck obstruction.
- Patients with known narrow-angle glaucoma.
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
End Date :
April 1 2006
Estimated Enrollment :
234 Patients enrolled
Trial Details
Trial ID
NCT00157235
Start Date
September 1 2002
End Date
April 1 2006
Last Update
December 28 2017
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
Fondazione "S. Maugeri"
Bari, Italy, 70020
2
Azienda Sanitaria Locale
Casorate Primo (PV), Italy, 27022
3
Arcispedale S. Anna
Ferrara, Italy, 44100
4
U.O. dimedicina Preventiva del Lavoro
Genova, Italy, 16132