Clinical Core

本PPG的临床核心（核心B）部分将提供临床专业知识和组织 必要的，以完成涉及人类受试者的研究中提出的项目在此范围内， PPG。核心将负责受试者招募和沟通，临床标本采集， 通过临床数据采集和受试者随访确定受试者特征。临床核心将与 与组织处理和细胞培养核心C密切合作，以确保临床样本的分发， 向项目调查人员提供数据。在这种能力下，临床核心将作为一个集体资源， PPG将促进三个项目中每一个项目的完成，并促进 从有价值的临床样本中收集最多的信息。招募后， 核心将使用各种临床参数将受试者分成四个明确定义的亚组：1）非过敏性， 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，和4） 过敏性哮喘志愿者将接受包括肺功能在内的综合评估 测试、过敏皮肤测试、血液测试和呼出气体测量。志愿者也将 接受门诊柔性纤维支气管镜检查。通过这个过程，核心将获得气道 标本包括粘膜刷、支气管肺泡灌洗液和支气管内活检组织。 这些样本将允许核心评估气道炎症的参数，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 PPG中使用人类受试者样本的研究，临床核心将负责确保 受试者安全、数据保密和完全合规。

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.