Design of the Subpopulations and Intermediate Outcomes in COPD Study (SPIROMICS).
Design of the Subpopulations and Intermediate Outcomes in COPD Study (SPIROMICS).
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DOI：
10.1136/thoraxjnl-2013-203897
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发表时间：
2014-05
期刊：
影响因子：
10
通讯作者：
SPIROMICS Research Group
中科院分区：
文献类型：
--
作者：
Couper D;LaVange LM;Han M;Barr RG;Bleecker E;Hoffman EA;Kanner R;Kleerup E;Martinez FJ;Woodruff PG;Rennard S;SPIROMICS Research Group
SPIROMICS是一项针对慢性阻塞性肺疾病（COPD）的多中心观察性研究，旨在通过以下方式指导COPD治疗的未来发展：1)提供可靠的标准，将COPD参与者细分为最有可能从临床试验中获益的组，从而提高成功结果的机会；2)确定生物标志物/表型，这些生物标志物/表型可作为治疗试验期间可靠预测临床获益的中间结果，从而降低成本。目标是招募3,200名参与者，分为四个层次：重度COPD，轻度/中度COPD，无气流阻塞的吸烟者和非吸烟对照组。参与者接受基线访问，包括形态测量、肺活量测定、6分钟步行、吸气和呼气胸部CT以及一套标准化问卷。收集和储存生物标本，包括血浆、血清、DNA、尿液和诱导痰。每年进行三次随访检查，每季度进行一次电话检查，以评估病情恶化、住院和死亡率。一部分参与者正在接受支气管镜检查，一部分COPD患者将在病情加重期间接受评估。将进行病情恶化和死亡率的判定。SPIROMICS的设计是为了添加子研究和辅助研究来测试额外的假设。
SPIROMICS is a multi-center observational study of chronic obstructive pulmonary disease (COPD) designed to guide future development of therapies for COPD by 1) providing robust criteria for sub-classifying COPD participants into groups most likely to benefit from a given therapy during a clinical trial, thereby improving the chances of successful outcome; and 2) identifying biomarkers/phenotypes that can be used as intermediate outcomes to reliably predict clinical benefit during therapeutic trials, thus reducing costs. The goal is to enroll 3,200 participants in four strata: severe COPD, mild/moderate COPD, smokers without airflow obstruction and non-smoking controls. Participants undergo a baseline visit including morphometric measures, spirometry, six-minute walk, an inspiratory and expiratory chest CT, and a set of standardized questionnaires. Biospecimens, including plasma, serum, DNA, urine and induced sputum, are collected and stored. There are three annual follow-up examinations, with quarterly telephone calls to assess for exacerbations, hospitalizations and mortality. Bronchoscopy is being performed in a subset of participants and a subset of COPD patients will be assessed during exacerbations. Adjudication of exacerbations and mortality will be undertaken. SPIROMICS is designed so that sub-studies and ancillary studies testing additional hypotheses can be added.
影响因子：
2.2
作者：
Regan EA;Hokanson JE;Murphy JR;Make B;Lynch DA;Beaty TH;Curran-Everett D;Silverman EK;Crapo JD
通讯作者：
Crapo JD
影响因子：
24.3
作者：
Vestbo, J.;Anderson, W.;Tal-Singer, R.
通讯作者：
Tal-Singer, R.