Back to Journals » International Journal of Chronic Obstructive Pulmonary Disease » Volume 6

Changing patterns in long-acting bronchodilator trials in chronic obstructive pulmonary disease

Authors James F Donohue, Paul W Jones

Published 7 January 2011 Volume 2011:6 Pages 35—45

DOI https://doi.org/10.2147/COPD.S14680

Review by Single-blind

Peer reviewer comments 5

James F Donohue1, Paul W Jones2
1Division of Pulmonary Disease and Critical Care Medicine, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; 2St. George's, University of London, London, UK

Abstract: Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality worldwide. Developments in the understanding of COPD have led to standard guidelines for diagnosis, treatment, and spirometry assessments, which have in turn influenced trial designs and inclusion criteria. Substantial clinical evidence has been gained from clinical trials and supports a positive approach to COPD management. However, there appear to be changing trends in recent trials. Large bronchodilator studies have reported lower improvements in trough forced expiratory volume in 1 second (FEV1) values versus placebo than were observed in earlier studies, while the rate of FEV1 decline seems to be lower in more recent trials. In addition, recent evidence has called into question the usefulness of bronchodilator reversibility testing as a trial inclusion criterion. Baseline patient populations and use of concomitant medications have also changed over recent years due to increased treatment options. The impact of these many variables on clinical trial results is explored, with a particular focus on changes in inclusion criteria and patient baseline demographics.

Keywords: chronic obstructive pulmonary disease, clinical trials, forced expiratory volume in 1 second, long-acting bronchodilators, lung function

Creative Commons License This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

Download Article [PDF]  View Full Text [HTML][Machine readable]

 

Readers of this article also read:

Intracellular targeted co-delivery of shMDR1 and gefitinib with chitosan nanoparticles for overcoming multidrug resistance

Yu XW, Yang G, Shi YJ, Su C, Liu M, Feng B, Zhao L

International Journal of Nanomedicine 2015, 10:7045-7056

Published Date: 12 November 2015

Effect of heparan sulfate and gold nanoparticles on muscle development during embryogenesis

Zielinska M, Sawosz E, Grodzik M, Wierzbicki M, Gromadka M, Hotowy A, Sawosz F, Lozicki A, Chwalibog A

International Journal of Nanomedicine 2011, 6:3163-3172

Published Date: 6 December 2011

Severity of COPD at initial spirometry-confirmed diagnosis: data from medical charts and administrative claims

Mapel DW, Dalal AA, Blanchette CM, Petersen H, Ferguson GT

International Journal of Chronic Obstructive Pulmonary Disease 2011, 6:573-581

Published Date: 9 November 2011

Delivery characteristics and patients’ handling of two single-dose dry-powder inhalers used in COPD

Chapman KR, Fogarty CM, Peckitt C, Lassen C, Jadayel D, Dederichs J, Dalvi M, Kramer B

International Journal of Chronic Obstructive Pulmonary Disease 2011, 6:353-363

Published Date: 23 June 2011