Chest
Original ResearchCOPDTreadmill Endurance During 2-Year Treatment With Tiotropium in Patients With COPD: A Randomized Trial
Section snippets
Study Design
This randomized, placebo-controlled, double-blind, parallel-group study compared 96 weeks of treatment with tiotropium 18 μg via HandiHaler (Boerhringer Ingelheim International GmbH) vs placebo on exercise duration in patients with COPD.6 Patients continued all respiratory medications other than inhaled anticholinergics. An incremental treadmill protocol was conducted during screening (visit 1). During a 2-week baseline period (3 weeks for patients taking tiotropium in the 2 weeks prior to
Results
A total of 713 patients were screened, and 519 patients were randomized (placebo, n = 259; tiotropium, n = 260) (Fig 1). Altogether, 464 patients were analyzed for the primary end point. Premature discontinuation was more frequent with placebo (96 patients vs 66 patients, hazard ratio for tiotropium/placebo [95% CI], 0.61 [0.44-0.83]; P = .002) (Fig 2), with a difference in mean treatment exposure of approximately 2 months (506 ± 252 days vs 572 ± 209 days). Adverse events leading to
Discussion
Our longitudinal study of exercise ET in moderate to very severe COPD found that tiotropium resulted in consistently longer ETs than placebo at 90% of maximum work rate (approximately 40 s) over 2 years. However, the primary end point of the difference in ET between treatment groups at 96 weeks was not statistically significant. Lung function (FEV1 and FVC) was improved along with health status, as measured by the SGRQ.
Sustained bronchodilation with tiotropium reduces static and dynamic
Acknowledgments
Author contributions: Dr Cooper is the guarantor for the manuscript content.
Dr Cooper: contributed to the study design, monitoring, and the statistical analysis plan of the study; was an investigator in the trial; participated in the review and interpretation of the data; and contributed to the manuscript.
Dr Celli: contributed as an investigator in the trial, participated in the review and interpretation of the data, and contributed to the manuscript.
Dr Jardim: contributed as an investigator in
References (32)
- et al.
Improvements in symptom-limited exercise performance over 8 h with once-daily tiotropium in patients with COPD
Chest
(2005) - et al.
Improvement in exercise tolerance with the combination of tiotropium and pulmonary rehabilitation in patients with COPD
Chest
(2005) - et al.
Advantages of endurance treadmill walking compared with cycling to assess bronchodilator therapy
Chest
(2010) - et al.
Updating the minimal important difference for six-minute walk distance in patients with chronic obstructive pulmonary disease
Arch Phys Med Rehabil
(2010) - et al.
Withdrawal from treatment as an outcome in the ISOLDE study of COPD
Chest
(2003) - et al.
Pulmonary rehabilitation: joint ACCP/AACVPR evidence-based clinical practice guidelines
Chest
(2007) - et al.
Effect of indacaterol on exercise endurance and lung hyperinflation in COPD
Respir Med
(2011) - et al.
Exercise capacity deterioration in patients with COPD: longitudinal evaluation over 5 years
Chest
(2005) The connection between chronic obstructive pulmonary disease symptoms and hyperinflation and its impact on exercise and function
Am J Med
(2006)Exercise in chronic pulmonary disease: limitations and rehabilitation
Med Sci Sports Exerc
(2001)
Global strategy for the diagnosis, management, and prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2013. GOLD website
Effects of tiotropium on lung hyperinflation, dyspnoea and exercise tolerance in COPD
Eur Respir J
Development and implementation of treadmill exercise testing protocols in COPD
Int J Chronic Obstruct Pulmon Dis
Spirometric reference values from a sample of the general US population
Am J Respir Crit Care Med
A treadmill ramp protocol using simultaneous changes in speed and grade
Med Sci Sports Exerc
Spirometric correlates of improvement in exercise performance after anticholinergic therapy in chronic obstructive pulmonary disease
Am J Respir Crit Care Med
Cited by (38)
Broadening the Perspective of Cost-Effectiveness Modeling in Chronic Obstructive Pulmonary Disease: A New Patient-Level Simulation Model Suitable to Evaluate Stratified Medicine
2019, Value in HealthCitation Excerpt :The model was implemented in R using RStudio (version 1.1.383). Longitudinal data from the tiotropium trials (UPLIFT, EXACTT, POET, TIOSPIR, and TONADO10–14) were used to estimate the time-to-event equations and the regression equations describing the associations between patient characteristics and outcomes over time. Because only the longitudinal data of patients in the tiotropium arms of the trials (19,378 patients) were used to estimate the equations, the outcomes of the model were deemed representative for a patient population treated with tiotropium (comparator).
Chronic Obstructive Pulmonary Disease in Post-acute/Long-term Care Settings: Seizing Opportunities to Individualize Treatment and Device Selection
2017, Journal of the American Medical Directors Association
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.