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Title: Treadmill Endurance During 2-Year Treatment With Tiotropium in Patients With COPD A Randomized Trial
Authors: Cooper, Christopher B.
Celli, Bartolome R.
Jardim, Jose R. [UNIFESP]
Wise, Robert A.
Legg, Daniel
Guo, Junhai
Kesten, Steven
Univ Calif Los Angeles
Brigham & Womens Hosp
Universidade Federal de São Paulo (UNIFESP)
Johns Hopkins Asthma & Allergy Ctr
Boehringer Ingelheim Pharmaceut Inc
Cytori Therapeut Inc
Issue Date: 1-Aug-2013
Publisher: Amer Coll Chest Physicians
Citation: Chest. Northbrook: Amer Coll Chest Physicians, v. 144, n. 2, p. 490-497, 2013.
Abstract: Background: Disease progression in COPD is associated with a decline in exercise performance over time. We assessed whether tiotropium might mitigate this by determining its effect on treadmill endurance time (ET) over 2 years.Methods: This was a randomized, double-blind, placebo-controlled trial of tiotropium, 18 mu g daily, in patients with COPD (FEV1/FVC <70%; postbronchodilator FEV1 <65%). the primary end point was ET at 90% of baseline maximum work rate at 96 weeks. Secondary end points were ET at other visits, ET by smoking status, spirometry, and St. George's Respiratory Questionnaire (SGRQ).Results: A total of 519 patients were randomized (tiotropium 260, placebo 259). Mean age was 65 years, 77% were men, 34% were continuing smokers, and mean FEV1 was 1.25 L (44% predicted). Significantly more patients discontinued placebo (hazard ratio [95% CI], 0.61 [0.44-0.83]). Baseline ET was 301 s (improvement tiotropium/placebo was 13% overall; P = .009; 18% at 48 weeks, P = .004; 13% at 96 weeks, P = .106). in patients with baseline ET between 2 and 10 min (n = 404), improvement at 96 weeks was 19% (P = .04). Current smokers had higher ET with tiotropium vs placebo (P = .018). FEV1/FVC improved with tiotropium (P < .01). SGRQ total score at 96 weeks improved with tiotropium vs placebo by 4.03 units (P = .007).Conclusions: Treadmill ET was numerically greater over 2 years with tiotropium vs placebo. However, the 96-week difference was not statistically significant. Spirometry and health status also improved with tiotropium over 2 years, attesting to the benefits of long-acting bronchodilator therapy.Trial registry:; No.: NCT00525512; URL:
ISSN: 0012-3692
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