Losartan Effects on Emphysema Progression Randomized Clinical Trial: Rationale, Design, Recruitment, and Retention.
Losartan Effects on Emphysema Progression Randomized Clinical Trial: Rationale, Design, Recruitment, and Retention.
复制标题
DOI：
10.15326/jcopdf.2021.0210
复制
发表时间：
2021-08
期刊：
影响因子：
--
通讯作者：
R. Wise;J. Holbrook;Robert H. Brown;G. Criner;M. Dransfield;M. Han;J. Krishnan;E. Looney;E. Neptune;Vicky Palombizio;Alexis L Rea
中科院分区：
文献类型：
--
作者：
R. Wise;J. Holbrook;Robert H. Brown;G. Criner;M. Dransfield;M. Han;J. Krishnan;E. Looney;E. Neptune;Vicky Palombizio;Alexis L Rea
氯沙坦对肺气肿进展的影响（LEEP）试验旨在检验氯沙坦减缓慢性阻塞性肺疾病（COPD）患者肺气肿进展的假设（NCT 00720226）。该研究由肺试验合作联盟与美国肺脏协会航空临床研究中心网络合作进行。我们描述了试验的设计和参与者招募和随访的挑战。LEEP是一项安慰剂对照、平行随机试验，分配比例为1：1，计划样本量为220例。主要合格标准是基于高分辨率计算机断层扫描（HRCT）的轻度肺气肿，5%至35%的体素<-950 Hounsfield单位（HU），基于肺功能测定的气道阻塞，以及未服用血管紧张素受体阻滞剂或血管紧张素转换酶（ACE）抑制剂。参与者接受氯沙坦或安慰剂治疗48周。共有2779人进行了筛选，招募220名合格的参与者在26个临床研究中心，所有位于美国大陆。招募时间比计划长45%（32个月比22个月），平均招募率为每月6.7名参与者。招募的挑战包括确定合格的参与者，他们没有服用或没有确定的血管紧张素受体阻滞剂或ACE抑制剂药物的临床适应症，以及食品和药物管理局召回受污染的氯沙坦批次。作为回应，发起了一些征聘举措。招募工作于2020年2月完成，就在2019冠状病毒病（COVID-19）大流行导致全国范围内停止研究活动之前。
The Losartan Effects on Emphysema Progression (LEEP) trial was designed to test the hypothesis that losartan slows progression of emphysema in chronic obstructive pulmonary disease (COPD) patients (NCT00720226). It was conducted by the Pulmonary Trials Cooperative consortium, in collaboration with the American Lung Association Airways Clinical Research Centers network. We describe the design of the trial and challenges for recruitment and follow-up of participants. LEEP is a placebo-controlled, parallel randomized trial, allocation ratio of 1:1, with a planned sample size of 220. Primary eligibility criteria were mild emphysema based on high-resolution computed tomography (HRCT) scans with 5% to 35% voxels <-950 Hounsfield units (HU), airway obstruction based on spirometry, and not taking an angiotensin receptor blocker or angiotensin converting enzyme (ACE) inhibitor. Participants received either losartan or placebo for 48 weeks. A total of 2779 individuals were screened to enroll 220 eligible participants at 26 clinical sites, all located in the continental United States. Recruitment took 45% longer than planned (32 months versus 22 months), with an average accrual rate of 6.7 participants per month. Recruitment challenges included identification of eligible participants who were not already taking or who did not have an established clinical indication for an angiotensin receptor blocker or ACE inhibitor drug and recalls of contaminated lots of losartan by the Food and Drug Administration. A number of recruitment initiatives were launched in response. Recruitment was completed in February 2020, just prior to a nationwide shutdown of research activities due to the coronavirus disease 2019 (COVID-19) pandemic.