Clinical Core: Exacerbation-Prone Pediatric Asthmatics and Control Populations

临床核心将实施和管理PPG的人类受试者研究 项目将中心所有项目的人类受试者研究活动集中起来， 通过整合必要的人员、设施和资源来节省工作量和成本。的 临床核心研究者和工作人员在类似的多项目中有成功的跟踪记录 临床研究方案十多年了临床核心方法已经过验证， 与调查人员一起进行初步研究。 目标1：招募、入组和保留研究受试者。临床研究方案将包括 一项纵向、前瞻性研究的急性发作倾向的哮喘儿童（n=100）和交叉， 三个对照组的截面生物采样：1）轻度、难治性哮喘儿童 （n=100）; 2）非哮喘、特应性儿童（n=50）;和3）非哮喘、非特应性儿童 （n=50）。这些对照组将用于表征气道、CD 4 + T细胞、 和不参与恶化的表面活性剂反应。 将通过IRB批准的方法确定受试者以进行招募， 招聘数据库、电子病历以及公共、诊所和医院 广告.潜在的参与者将通过问卷进行筛选， 信息和入选和排除标准。关于《公约》的纵向后续行动， 易加重组，临床核心团队有很强的入组史，招募， 在城市哮喘儿童的纵向研究中，参与者保持率>90%。 目的2：通过哮喘和特应性对参与者进行临床表征 研究对象的表型分析和生物取样。表型分析将包括测定 哮喘、特应性状态、加重和哮喘严重程度。生物样本将包括诱导的 痰、鼻刷、鼻粘液、血液和尿液。 目标3：提供数据和样本管理。临床中心将提供生物样本 跟踪、路由、准备和测试，并将向项目提供去识别数据， 生物统计学、生物信息学和环境采样核心。表型分析数据将 进入符合HIPPA标准、IRB批准的REDCap（研究电子数据采集） 数据库（NIH/NCATS科罗拉多CTSI授权号UL 1 TR 001082）。

The Clinical Core will implement and manage the human subjects research for the PPG Projects. Centralizing the human subjects research activities for all projects of the Center will save effort and cost by consolidating the necessary personnel, facilities, and resources. The Clinical Core investigator and personnel have a successful track record with similar multi-project clinical research protocols for over a decade. The Clinical Core approach has been validated by preliminary studies with the investigators in this proposal. Aim 1: Recruit, enroll, and retain study subjects. The clinical research protocol will consist of a longitudinal, prospective study of exacerbation-prone asthmatic children (n=100) and cross- sectional biosampling of three control groups: 1) mild, exacerbation-resistant asthmatic children (n=100); 2) non-asthmatic, atopic children (n=50); and 3) non-asthmatic, non-atopic children (n=50). These control groups will be used to characterize the spectrum of airway, CD4+ T cell, and surfactant responses that are not involved in exacerbations. Participants will be identified for recruitment through IRB-approved means using recruitment databases, electronic medical records, and public, clinic, and hospital advertisements. Potential participants will be screened with a questionnaire that collects contact information and inclusion and exclusion criteria. Regarding longitudinal follow-up of the exacerbation-prone group, the Clinical Core team has a strong history of enrollment, recruitment, and >90% participant retention in longitudinal studies of urban children with asthma. Aim 2: Perform clinical characterization of participants through asthma and atopy phenotyping and biosampling of study subjects. Phenotyping will include a determination of asthma, atopic status, exacerbations, and asthma severity. Biosamples will include induced sputum, nasal brush, nasal mucus, blood, and urine. Aim 3: Provide data and sample management. The Clinical Core will provide biosample tracking, routing, preparation and testing, and will provide de-identified data to the Projects and the Biostatistics, Bioinformatics and Environmental Sampling Core. Phenotyping data will be entered into a HIPPA-compliant, IRB-approved REDCap (Research Electronic Data Capture) database (NIH/NCATS Colorado CTSI Grant Number UL1 TR001082).