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* From the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center (Dr. Casaburi), Torrance, CA; North Colorado Pulmonary Consultants PC (Dr. Kukafka), Fort Collins, CO; David Geffen School of Medicine (Dr. Cooper), University of California, Los Angeles, CA; and Boehringer Ingelheim Pharmaceuticals, Inc. (Drs. Witek and Kesten), Ridgefield, CT.
Correspondence to: Richard Casaburi, PhD, MD, FCCP, Chief, Division of Respiratory and Critical Care Physiology and Medicine, Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, 1124 W Carson St, Building RB-2, Torrance, CA 90502; e-mail: casaburi{at}ucla.edu
Study objectives: Pulmonary rehabilitation (PR) improves exercise tolerance in COPD patients. Tiotropium is a once-daily, inhaled anticholinergic bronchodilator that provides sustained 24-h improvements in airflow and lung hyperinflation reduction. We hypothesized that ventilatory mechanics improvements from tiotropium would permit enhanced ability to train muscles of ambulation and therefore augment exercise tolerance benefits of PR.
Design: In a randomized, double-blind, placebo-controlled trial (tiotropium, n = 47; placebo, n = 44), tiotropium (18 µg qd) was administered to COPD patients participating in 8 weeks of PR (treadmill training three times a week; 
30 min per session) at 17 sites. Study drug was administered 5 weeks prior to, 8 weeks during, and 12 weeks following PR. The primary end point was treadmill walking (0% incline) endurance time at 80% of maximum speed attained in an initial incremental test. The transition dyspnea index (TDI), St. George’s respiratory questionnaire (SGRQ), and rescue albuterol use were secondary end points.
Participants: Mean age of the 93 participants was 67 years, 57% were men, and mean FEV1 was 0.88 L (34% predicted).
Results: Mean endurance time differences (tiotropium minus placebo) prior to PR, at the end of PR, and 12 weeks after PR were 1.65 min (p = 0.183), 5.35 min (p = 0.025), and 6.60 min (p = 0.018), respectively. Mean TDI focal scores at the end of PR were 1.75 for tiotropium and 0.91 for placebo (p > 0.05). At 12 weeks after PR, TDI focal scores were 1.75 for tiotropium and 0.08 for placebo (p < 0.05). Relative to placebo, tiotropium improved SGRQ total scores by 3.86 at the end of PR and 4.44 at 12 weeks after PR (p > 0.05). Mean albuterol use declined following PR plus tiotropium, compared to PR alone (p 
0.05 for 17 of 25 weeks).
Conclusions: Tiotropium in combination with PR improved endurance of a constant work rate treadmill task and produced clinically meaningful improvements in dyspnea and health status compared to PR alone. Improvements with tiotropium were sustained for 3 months following PR completion.
Key Words: COPD • exercise • pulmonary rehabilitation • tiotropium
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