-
Randomized Controlled Trial Multicenter Study Observational Study
Design of the Subpopulations and Intermediate Outcomes in COPD Study (SPIROMICS).
- David Couper, Lisa M LaVange, MeiLan Han, R Graham Barr, Eugene Bleecker, Eric A Hoffman, Richard Kanner, Eric Kleerup, Fernando J Martinez, Prescott G Woodruff, Stephen Rennard, and SPIROMICS Research Group.
- Department of Biostatistics, University of North Carolina at Chapel Hill, , Chapel Hill, North Carolina, USA.
- Thorax. 2014 May 1;69(5):491-4.
AbstractSubpopulations 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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