0
Original Research: COPD |

Treadmill Endurance During 2-Year Treatment With Tiotropium in Patients With COPDTreadmill Endurance and Tiotropium in COPD: A Randomized Trial

Christopher B. Cooper, MD, FCCP; Bartolome R. Celli, MD, FCCP; José R. Jardim, MD; Robert A. Wise, MD, FCCP; Daniel Legg, MPH; Junhai Guo, PhD; Steven Kesten, MD, FCCP
Author and Funding Information

From the David Geffen School of Medicine (Dr Cooper), University of California, Los Angeles, CA; the Brigham and Women’s Hospital (Dr Celli), Boston, MA; Federal University of São Paulo (Dr Jardim), São Paulo, Brazil; the Johns Hopkins Asthma and Allergy Center (Dr Wise), Baltimore, MD; Boehringer Ingelheim Pharmaceuticals Inc (Mr Legg and Dr Guo), Ridgefield, CT; and Cytori Therapeutics, Inc (Dr Kesten), San Diego, CA.

Correspondence to: Christopher B. Cooper, MD, FCCP, Department of Medicine and Physiology, David Geffen School of Medicine, University of California, Los Angeles (UCLA), 10833 Le Conte Ave, 37-131 CHS, Los Angeles, CA 90095-1690; e-mail: ccooper@mednet.ucla.edu


Funding/Support: This study was funded jointly by Boehringer Ingelheim Pharma GmbH & Co KG and Pfizer, Inc.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians. See online for more details.


Chest. 2013;144(2):490-497. doi:10.1378/chest.12-2613
Text Size: A A A
Published online

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 μg 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:  ClinicalTrials.gov; No.: NCT00525512; URL: www.clinicaltrials.gov

Figures in this Article

Sign In to Access Full Content

MEMBER & INDIVIDUAL SUBSCRIBER

Want Access?

NEW TO CHEST?

Become a CHEST member and receive a FREE subscription as a benefit of membership.

Individuals can purchase this article on ScienceDirect.

Individuals can purchase a subscription to the journal.

Individuals can purchase a subscription to the journal or buy individual articles.

Learn more about membership or Purchase a Full Subscription.

INSTITUTIONAL ACCESS

Institutional access is now available through ScienceDirect and can be purchased at myelsevier.com.

Sign In to Access Full Content

MEMBER & INDIVIDUAL SUBSCRIBER

Want Access?

NEW TO CHEST?

Become a CHEST member and receive a FREE subscription as a benefit of membership.

Individuals can purchase this article on ScienceDirect.

Individuals can purchase a subscription to the journal.

Individuals can purchase a subscription to the journal or buy individual articles.

Learn more about membership or Purchase a Full Subscription.

INSTITUTIONAL ACCESS

Institutional access is now available through ScienceDirect and can be purchased at myelsevier.com.

Figures

Tables

References

NOTE:
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).

Some tools below are only available to our subscribers or users with an online account.

Sign In to Access Full Content

MEMBER & INDIVIDUAL SUBSCRIBER

Want Access?

NEW TO CHEST?

Become a CHEST member and receive a FREE subscription as a benefit of membership.

Individuals can purchase this article on ScienceDirect.

Individuals can purchase a subscription to the journal.

Individuals can purchase a subscription to the journal or buy individual articles.

Learn more about membership or Purchase a Full Subscription.

INSTITUTIONAL ACCESS

Institutional access is now available through ScienceDirect and can be purchased at myelsevier.com.

Related Content

Customize your page view by dragging & repositioning the boxes below.

Find Similar Articles
CHEST Journal Articles
PubMed Articles
  • CHEST Journal
    Print ISSN: 0012-3692
    Online ISSN: 1931-3543