Human Clinical Core

该TPPG的人类临床核心(核心B)部分将提供临床专业知识和 完成项目中提出的涉及人类对象的研究所必需的组织 在这个TPPG内。核心将负责学科招募和沟通，临床标本 通过临床数据收集、受试者特征描述和受试者随访。临床核心 将与哮喘生物资料库核心C密切互动，以确保临床样本和 将数据提供给程序调查人员。在这一能力中，临床核心将发挥集体资源的作用 促进完成三个项目中的每一个项目，并促进 从有价值的临床样本中收集最多信息的不同项目。招募后，CORE将使用各种临床参数将受试者分为四个明确的亚组：1)非过敏性、非哮喘正常志愿者，2)过敏性非哮喘者，3)非过敏性哮喘者，以及4)过敏性哮喘者。志愿者将接受全面的评估，包括肺功能测试、过敏皮肤测试、血液测试和呼气测量。选定的志愿者还将接受门诊柔性纤维支气管镜检查。通过这一程序，核心将获得AIN//AY样本，包括粘膜刷子、支气管肺泡灌洗液和支气管腔内活检组织。 这些标本将允许核心评估呼吸道炎症的参数，并将由哮喘生物储存库核心C进一步处理，供所有四个TPPG项目使用。对于TPPG内使用人类受试者样本的所有研究，临床核心将负责确保受试者安全、数据机密性和完全遵守法规。

The Human Clinical Core (Core B) component of this TPPG will provide the clinical expertise and organization necessary to accomplish the studies involving human subjects that are proposed in the projects within this TPPG. The core will be responsible for subject recruitment and communication, clinical specimen collection, subject characterization through clinical data acquisition and subject follow-up. The Clinical Core will interact intimately with the Asthma Biorepository Core C to ensure distribution of clinical samples and data to program investigators. In this capacity, the clinical core will function as a collective resource to the TPPG that will facilitate accomplishment of each of the three projects and also promote interaction between the different projects to glean the most information from valuable clinical samples. Following recruitment, the core will use a variety of clinical parameters to divide subjects into four well-defined subgroups: 1) nonallergic, non-asthmatic normal volunteers, 2) allergic non-asthmatics, 3) non-allergic asthmatics, and 4) allergic asthmatics. The volunteers will undergo a comprehensive evaluation Including pulmonary function testing, allergy skin testing, blood testing and exhaled gas measurements. Select volunteers will also undergo outpatient flexible fiberoptic bronchoscopy. Through this procedure the core will obtain ain/\/ay specimens including mucosal brushings, bronchoalveolar lavage fluid, and endobronchial biopsy tissue. These specimens will allow the core to assess parameters of ainway inflammation and will be further processed by the Asthma Biorepository Core C for use by all four TPPG projects. For all of the studies within the TPPG utilizing human subject samples, the clinical core will be responsible for assuring subject safety, data confidentiality and full regulatory compliance.