title: Design of the Subpopulations and Intermediate Outcomes in COPD Study (SPIROMICS).
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.
authors.affiliation: Department of Biostatistics, University of North Carolina at Chapel Hill, , Chapel Hill, North Carolina, USA.
authors.forename: David
authors.initials: D
authors.lastname: Couper
authors.forename: Lisa M
authors.initials: LM
authors.lastname: LaVange
authors.forename: MeiLan
authors.initials: M
authors.lastname: Han
authors.forename: R Graham
authors.initials: RG
authors.lastname: Barr
authors.forename: Eugene
authors.initials: E
authors.lastname: Bleecker
authors.forename: Eric A
authors.initials: EA
authors.lastname: Hoffman
authors.forename: Richard
authors.initials: R
authors.lastname: Kanner
authors.forename: Eric
authors.initials: E
authors.lastname: Kleerup
authors.forename: Fernando J
authors.initials: FJ
authors.lastname: Martinez
authors.forename: Prescott G
authors.initials: PG
authors.lastname: Woodruff
authors.forename: Stephen
authors.initials: S
authors.lastname: Rennard
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015415:Biomarkers / Q000378:metabolism; D019468:Disease Management; D005500:Follow-Up Studies; D011379:Prognosis; D011446:Prospective Studies; D029424:Pulmonary Disease, Chronic Obstructive / Q000000981:diagnostic imaging / Q000378:metabolism / Q000628:therapy; D013147:Spirometry; D011795:Surveys and Questionnaires; D014057:Tomography, X-Ray Computed
chemical_list: D015415:Biomarkers
keywords: COPD Exacerbations; COPD epidemiology; Emphysema; Imaging/CT MRI etc
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