Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE)

ECLIPSE was a longitudinal observational study of 2164 COPD subjects and a smaller number of smoking controls (337) and nonsmoking controls (245) followed regularly for three years, with three chest CT scans (at baseline, one year, and three years) (Vestbo, European Respiratory Journal 2008; 31: 869). Inclusion criteria included age 40-75, at least 10 pack-years of smoking, and spirometry in GOLD grades 2-4 (COPD cases) or normal spirometry with post-bronchodilator FEV1 >85% predicted and FEV1/FVC>0.7 (controls). Study visits were performed at enrollment, three months, and every six months thereafter with spirometry, questionnaires, and other clinical evaluations. The ECLIPSE CT scans have been analyzed with the VIDA software for emphysema and airway phenotypes. ECLIPSE has provided key insights into the clinical epidemiology of COPD, including COPD exacerbations (Hurst, NEJM 2010; 363: 1128) and lung function decline in COPD (Vestbo, NEJM 2011; 365: 1184). ECLIPSE has been used in a number of genetic studies of COPD susceptibility and protein biomarkers(Faner, Thorax 2014; 69: 666). Genome-wide gene expression microarray data are available in 147 induced sputum samples from COPD subjects and 248 peripheral blood samples from COPD and control subjects.

ECLIPSE是一项纵向观察性研究，纳入2164例慢性阻塞性肺疾病（Chronic Obstructive Pulmonary Disease, COPD）受试者，以及337例吸烟对照与245例非吸烟对照，定期随访三年，期间分别于基线、1年及3年时完成三次胸部CT扫描（Vestbo, 《欧洲呼吸杂志》2008; 31: 869）。纳入标准为年龄40~75岁，吸烟史至少10包-年；其中COPD病例需符合慢性阻塞性肺疾病全球倡议（Global Initiative for Chronic Obstructive Lung Disease, GOLD）分级2~4级的肺功能标准，对照个体则需肺功能正常，且支气管舒张后第一秒用力呼气容积（Forced Expiratory Volume in 1 Second, FEV1）占预计值百分比>85%、FEV1与用力肺活量（Forced Vital Capacity, FVC）的比值>0.7。研究访视安排在入组时、入组后3个月进行，此后每6个月开展一次，每次均进行肺功能检测、问卷调查及其他临床评估。ECLIPSE研究的胸部CT扫描已通过VIDA软件针对肺气肿及气道表型完成分析。该研究为COPD临床流行病学领域提供了关键洞见，涵盖COPD急性加重（Hurst, 《新英格兰医学杂志》2010; 363: 1128）及COPD患者肺功能下降情况（Vestbo, 《新英格兰医学杂志》2011; 365: 1184）等核心内容。ECLIPSE已被应用于多项COPD易感性及蛋白质生物标志物相关的遗传学研究（Faner, 《胸科》2014; 69: 666）。目前已有147份COPD受试者诱导痰样本及248份COPD与对照受试者外周血样本的全基因组基因表达微阵列数据可供使用。