Clinical Core

PPG的临床核心(核心B)部分将提供临床专业知识和组织 有必要完成项目中提出的涉及人体对象的研究 PPG。核心将负责受试者招募和沟通，临床标本收集， 通过临床数据采集和受试者随访来确定受试者的特征。临床核心将相互作用 与组织处理和细胞培养核心C密切合作，确保临床样本的分发和 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 PPG将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。在招募之后， CORE将使用各种临床参数将受试者分为四个定义明确的亚组：1)不过敏， 非哮喘正常志愿者，2)过敏性非哮喘患者，3)非过敏性哮喘患者，4) 过敏性哮喘患者。志愿者将接受包括肺功能在内的全面评估 测试、过敏皮肤测试、血液测试和呼出气体测量。选定的志愿者也将 接受门诊柔性纤维支气管镜检查。通过这一过程，核心将获得呼吸道 标本包括粘膜刷子、支气管肺泡灌洗液和支气管镜活检组织。 这些标本将允许核心评估呼吸道炎症的参数，并将进一步 由组织处理和细胞培养核心C处理，供所有三个PPG项目使用。对于所有的 在PPG内利用人类受试者样本进行的研究，临床核心将负责确保 主题安全、数据保密性和完全法规遵从性。

The Clinical Core (Core B) component of this PPG will provide the clinical expertise and organization necessary to accomplish the studies involving human subjects that are proposed in the projects within this PPG. 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 Tissue Processing and Cell Culture 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 PPG 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 airway specimens including mucosal brushings, bronchoalveolar lavage fluid, and endobronchial biopsy tissue. These specimens will allow the core to assess parameters of airway inflammation and will be further processed by the Tissue Processing and Cell Culture Core C for use by all three PPG projects. For all of the studies within the PPG utilizing human subject samples, the clinical core will be responsible for assuring subject safety, data confidentiality and full regulatory compliance.