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Semin Respir Crit Care Med 2005; 26(2): 253-262
DOI: 10.1055/s-2005-869544
Copyright © 2005 by Thieme Medical Publishers, Inc., 333 Seventh Avenue, New York, NY 10001, USA.

Emerging Concepts in Outcome Assessment for COPD Clinical Trials

Sanjay A. Patel1 , Frank C. Sciurba1
  • 1Division of Pulmonary, Allergy, and Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania
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Publication History

Publication Date:
27 April 2005 (online)

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ABSTRACT

The selection of appropriate, clinically meaningful outcome measures for chronic obstructive pulmonary disease (COPD) clinical trials is a complex issue. Functional exercise measures are more likely to adequately reflect the effect of novel and emerging interventions than traditional physiological measures such as forced expiratory volume in 1 second (FEV1). Nonetheless, among several exercise measures commonly used, the choice is not a simple issue and should be based upon rational as well as pragmatic issues. This is because important measurement properties (validity and responsiveness) can differ among exercise measures, among different interventions, and across degrees of disability. Furthermore, “free-living” daily activity measures may be more meaningful measures than these “in-lab” exercise measures for future clinical trials of COPD, although their reproducibility, validity, and responsiveness have not yet been adequately studied. Application of these and other emerging concepts in outcome assessment for COPD clinical trials will be examined.

KEYWORDS

Exercise testing - COPD - outcome assessment

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Frank C SciurbaM.D. 

Division of Pulmonary, Allergy, and Critical Care Medicine, University of Pittsburgh

3471 Fifth Ave., Ste. 1211 Kaufmann Bldg.

Pittsburgh, PA 15213

Email: sciurbafc@upmc.edu

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