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

• Status: Completed
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: All

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 with chronic obstructive pulmonary disease (COPD) who participate in pulmonary rehabilitation.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Bromides; Tiotropium Bromide

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.