TY - JOUR
T1 - Treadmill endurance during 2-year treatment with tiotropium in patients with COPD
T2 - A randomized trial
AU - Cooper, Christopher B.
AU - Celli, Bartolome R.
AU - Jardim, José R.
AU - Wise, Robert A.
AU - Legg, Daniel
AU - Guo, Junhai
AU - Kesten, Steven
N1 - Funding Information:
Other contributions: We thank Inge Leimer, PhD, from Boehringer Ingelheim Pharma GmbH & Co KG for assistance with statistical methodology. Editorial support was provided by PAREXEL International and was funded jointly by Boehringer Ingelheim Pharma GmbH & Co KG and Pfizer, Inc.
Funding Information:
Financial/nonfinancial disclosures: The authors have reported to CHEST the following conflicts of interest: During the past three years, Dr Cooper has served on the global scientific advisory board for Boehringer Ingelheim Pharma GmbH & Co KG and Pfizer, Inc. He has also received advisory board payments from Forest Pharmaceuticals, Inc. Through UCLA, he has received research grant support from Boehringer Ingelheim GmbH and Pfizer, Inc for this and other studies. He has also received research support from e-Research Technologies; Aeris Therapeutics; Spiration, Inc; Eumedic; ROX Medical; and CSL-Behring. He has received honoraria for lecturing from Boehringer Ingelheim GmbH; Pfizer, Inc; AstraZeneca; Forest Pharmaceuticals; and GlaxoSmithKline. He has served as a paid consultant for CareFusion; eResearch Technologies; Forest Pharmaceuticals, Inc; and ROX Medical. Dr Celli has received grants to the Pulmonary Division he works in, from: Aeris Therapeutics, AstraZeneca, Boehringer Ingelheim Pharma GmbH & Co KG, Forest Pharmaceuticals, Inc; and GlaxoSmithKline. He has also received advisory board payments from: Aeris Therapeutics, Almirall, S.A., AstraZeneca, Boehringer Ingelheim Pharma GmbH & Co KG, Deep Breeze Ltd, GlaxoSmithKline, Novartis Corporation, and ROX Medical. Dr Jardim has received advisory board payments from GlaxoSmithKline, Novartis Corporation, and Takeda Pharmaceuticals International GmH, and received honoraria for lecturing from Bayer, Boehringer Ingelheim Pharma GmbH & Co KG, GlaxoSmithKline, Novartis Corporation, and Takeda Pharmaceuticals International GmbH. Dr Wise has served as a paid consultant for AstraZeneca, Boehringer Ingelheim Pharma GmbH & Co KG, GlaxoSmithKline, Mylan Inc, Novartis Corporation, and Sunovion Pharmaceuticals Inc. Mr Legg and Dr Guo are current employees of Boehringer Ingelheim Pharmaceuticals Inc. Dr Kesten was previously an employee of Boehringer Ingelheim Pharmaceuticals Inc.
PY - 2013/8
Y1 - 2013/8
N2 - 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 m g daily, in patients with COPD (FEV 1 /FVC < 70%; postbronchodilator FEV 1 < 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 FEV 1 was 1.25 L (44% predicted). Signifi cantly 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). FEV 1 /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 signifi cant. Spirometry and health status also improved with tiotropium over 2 years, attesting to the benefi ts of long-acting bronchodilator therapy.
AB - 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 m g daily, in patients with COPD (FEV 1 /FVC < 70%; postbronchodilator FEV 1 < 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 FEV 1 was 1.25 L (44% predicted). Signifi cantly 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). FEV 1 /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 signifi cant. Spirometry and health status also improved with tiotropium over 2 years, attesting to the benefi ts of long-acting bronchodilator therapy.
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U2 - 10.1378/chest.12-2613
DO - 10.1378/chest.12-2613
M3 - Article
C2 - 23558890
AN - SCOPUS:84881534452
SN - 0012-3692
VL - 144
SP - 490
EP - 497
JO - CHEST
JF - CHEST
IS - 2
ER -