Effect of Tiotropium Inhalation Capsules (Spiriva) on Exercise Tolerance in COPD Patients

Launched by BOEHRINGER INGELHEIM · Sep 7, 2005

Keywords

ClinConnect Summary

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 Tiotropio) in patients with COPD participating in a pulmonary rehabilitation program.

Following an initial screening, patients will perform a six minute walk test (Visit 1) and enter a 4-week run-in period. Patients will subsequently be randomized to tiotropium or placebo inhalation capsules taken once daily in the morning for the next 25 weeks. After successfully completing 4 weeks of study drug se...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • COPD patients with FEV1 less 60% of predicted FEV1 less 70% of FVC.
• Exclusion Criteria:
• • 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.