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Clinical Investigations: COPDImprovement in Exercise Tolerance With the Combination of Tiotropium and Pulmonary Rehabilitation in Patients With COPD
Section snippets
Study Design
This study is a 25-week, multicenter, single-country, randomized, double-blind, parallel-group clinical trial to determine the efficacy of tiotropium inhalation capsules compared to placebo on exercise tolerance in patients with COPD participating in a PR program. Randomization to tiotropium, 18 μg qd, or placebo occurred in a 1:1 ratio. Tiotropium or matching placebo were supplied as a dry-powder capsule and inhaled (HandiHaler device; Boehringer Ingelheim; Ingelheim, Germany) in the morning.
Results
A total of 108 patients were randomized and received at least one dose of study medication. The full analysis data sets included all randomized patients who had adequate baseline measurements and at least one efficacy measurement after the multiple administration of study medication. By this definition, 12 patients (6 in each treatment group) were excluded from all efficacy analyses. In addition to the 12 patients excluded from all efficacy analyses, 5 additional patients were excluded from the
Discussion
The purpose of the present study was to determine whether tiotropium enhances exercise training benefits in PR programs in COPD patients. In addition, this study sought to assess the impact of tiotropium on dyspnea and health-related quality of life following PR. Finally, the inclusion of a 12-week postrehabilitation period was used to determine whether benefits of PR are better maintained with tiotropium. Patients receiving tiotropium showed significantly longer exercise endurance time at the
References (25)
- et al.
A systematic review of the effects of bronchodilators on exercise capacity in patients with COPD
Chest
(2002) - et al.
Improvements in resting inspiratory capacity and hyperinflation with tiotropium in COPD with increased static lung volumes
Chest
(2003) - et al.
Fifteen year interval spirometric evaluation of the Oregon predictive equations
Chest
(1988) - et al.
Baseline dyspnea index and transitional dyspnea index: the measurement of dyspnea
Chest
(1984) - et al.
Meaningful effect size and patterns of response of the transition dyspnea index
J Clin Epidemiol
(2003) Pulmonary rehabilitation
Thorax
(2001)ACCP/AACVPR Pulmonary Rehabilitation Guidelines Panel
Chest
(1997)Pulmonary rehabilitation 1999
Am J Respir Crit Care Med
(1999)- et al.
Contractile leg fatigue after cycle exercise
Am J Respir Crit Care Med
(2003) - et al.
A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease
Eur Respir J
(2002)
Improvement in health status in patients with COPD during one year treatment with tiotropium
Eur Respir J
Effects of tiotropium on lung hyperinflation, dyspnea and exercise tolerance in COPD
Eur Respir J
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Dr. Casaburi holds the Alvin Grancell/Mary Burns Chair in the Rehabilitative Sciences. Dr. Casaburi is a consultant of Boehringer-Ingelheim Pharmaceuticals and Pfizer and serves on their Academic Advisory Board. Dr. Cooper receives research support from Boehringer-Ingelheim Pharmaceuticals and is a member of their Speaker's Bureau and Scientific Advisory Board. Drs. Witek and Kesten areemployees of Boehringer-Ingelheim Pharmaceuticals. This study was supported by Boehringer-Ingelheim Pharmaceuticals Inc. and Pfizer Inc