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Design of the subpopulations and intermediate outcomes in copd study (SPIROMICS)

机译:copd研究(SPIROMICS)中亚群和中间结果的设计

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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.
机译:COPD研究中的亚人群和中间结果(SPIROMICS)是一项慢性阻塞性肺疾病(COPD)的多中心观察性研究,旨在通过提供可靠的标准将COPD参与者细分为最有可能从给定治疗中受益的人群,从而指导COPD疗法的未来发展在临床试验中,并鉴定可用作中间结果的生物标志物/表型,以可靠地预测治疗试验中的临床获益。目标是在四个层次中招募3200名参与者。参加者进行一次基线访问,并进行三个年度随访检查,并每季度打电话一次。将对病情加重和死亡率进行裁决。

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