Evaluation of COPD longitudinally to identify predictive surrogate end-points (ECLIPSE)
Evaluation of COPD longitudinally to identify predictive surrogate end-points (ECLIPSE)
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DOI：
10.1183/09031936.00111707
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发表时间：
2008-04-01
影响因子：
24.3
通讯作者：
Tal-Singer, R.
中科院分区：
文献类型：
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作者：
Vestbo, J.;Anderson, W.;Tal-Singer, R.
慢性阻塞性肺疾病（COPD）是一种异质性疾病，目前尚不清楚。一秒用力呼气量用于 COPD 的诊断和分期，但人们普遍认为这是一种粗略的测量方法，并且对较短时间段内的变化不敏感。 纵向评估 COPD 以识别预测替代终点 (ECLIPSE) 是一项为期 3 年的纵向研究，有四个具体目标：1) 定义临床相关的 COPD 亚型； 2) 确定预测这些亚型疾病进展的参数； 3) 检查与 COPD 亚型相关并可预测疾病进展的生物标志物； 4) 鉴定与临床相关 COPD 亚型相关并预测疾病进展的新型遗传因素和/或生物标志物。ECLIPSE 计划在慢性阻塞性肺病全球倡议 II-IV 类中招募 2,180 名 COPD 受试者，以及 343 名吸烟受试者和 223 名非吸烟对照受试者。研究程序将在基线、3 个月、6 个月以及此后每 6 个月进行一次。评估包括肺功能测量（肺活量测定、脉冲振荡测量和体积描记法）、胸部计算机断层扫描、生物标志物测量（血液、痰液、尿液和呼出气体冷凝物）、健康结果、身体阻抗、静息氧饱和度和 6 分钟步行距离。 纵向评估慢性阻塞性肺病以确定预测替代终点是试图 更好地描述慢性阻塞性肺病的亚型，并确定其进展的预测标志物。
Chronic obstructive pulmonary disease (COPD) is a heterogeneous disease and not well understood. The forced expiratory volume in one second is used for the diagnosis and staging of COPD, but there is wide acceptance that it is a crude measure and insensitive to change over shorter periods of time.Evaluation of COPD Longitudinally to Identify Predictive Surrogate End-points (ECLIPSE) is a 3-yr longitudinal study with four specific aims: 1) definition of clinically relevant COPD subtypes; 2) identification of parameters that predict disease progression in these subtypes; 3) examination of biomarkers that correlate with COPD subtypes and may predict disease progression; and 4) identification of novel genetic factors and/or biomarkers that both correlate with clinically relevant COPD subtypes and predict disease progression.ECLIPSE plans to recruit 2,180 COPD subjects in Global Initiative for Chronic Obstructive Lung Disease categories II-IV and 343 smoking and 223 nonsmoking control subjects. Study procedures are to be performed at baseline, 3 months, 6 months and every 6 months thereafter. Assessments include pulmonary function measurements (spirometry, impulse oscillometry and plethysmography), chest computed tomography, biomarker measurement (in blood, sputum, urine and exhaled breath condensate), health outcomes, body impedance, resting oxygen saturation and 6-min walking distance.Evaluation of COPD Longitudinally to Identify Predictive Surrogate End-points is the largest study attempting to better describe the subtypes of chronic obstructive pulmonary disease, as well as defining predictive markers of its progression.