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Audit, research and guideline update
Design of the Subpopulations and Intermediate Outcomes in COPD Study (SPIROMICS)
  1. David Couper1,
  2. Lisa M LaVange1,
  3. MeiLan Han2,
  4. R Graham Barr3,
  5. Eugene Bleecker4,
  6. Eric A Hoffman5,
  7. Richard Kanner6,
  8. Eric Kleerup7,
  9. Fernando J Martinez8,
  10. Prescott G Woodruff9,
  11. Stephen Rennard10,
  12. for the SPIROMICS Research Group
  1. 1Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
  2. 2Division of Pulmonary & Critical Care, University of Michigan, Ann Arbor, Michigan, USA
  3. 3Department of Medicine, Columbia University, New York, New York, USA
  4. 4Center for Genomics and Personalized Medicine Research, Wake Forest University, Winston-Salem, New York, USA
  5. 5Department of Radiology, University of Iowa, Iowa City, Iowa, USA
  6. 6Department of Internal Medicine/Pulmonary and Critical Care Medicine, University of Utah, Salt Lake City, Utah, USA
  7. 7Department of Medicine, University of California at Los Angeles, Los Angeles, California, USA
  8. 8Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, USA
  9. 9Division of Pulmonary, Critical Care, Sleep and Allergy, Department of Medicine, University of California at San Francisco, San Francisco, California, USA
  10. 10Division of Pulmonary, Critical Care, Sleep & Allergy, Department of Internal Medicine, University of Nebraska, Omaha, Nebraska, USA
  1. Correspondence to Dr David Couper, Department of Biostatistics, University of North Carolina at Chapel Hill, CSCC, 137 E. Franklin Street, Suite 203, Chapel Hill, NC 27514, USA; david_couper{at}unc.edu

Abstract

Subpopulations and Intermediate Outcomes in COPD Study (SPIROMICS) is a multicentre observational study of chronic obstructive pulmonary disease (COPD) designed to guide future development of therapies for COPD by providing robust criteria for subclassifying COPD participants into groups most likely to benefit from a given therapy during a clinical trial, and identifying biomarkers/phenotypes that can be used as intermediate outcomes to reliably predict clinical benefit during therapeutic trials. The goal is to enrol 3200 participants in four strata. Participants undergo a baseline visit and three annual follow-up examinations, with quarterly telephone calls. Adjudication of exacerbations and mortality will be undertaken.

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