Core--Subject Characterization and Recruitment

这个合作研究中心的建议是独一无二的，因为拟议的项目将几乎 仅涉及人类受试者。为了最好地完成这些协议，已建立此核心 专门用于招募潜在受试者并进行筛选评价，以确定 他们是否有资格参加这些研究。拟议的项目将涉及两组不同的 患者第一个将集中在对猫过敏原过敏的患者身上，他们将被纳入鼻腔挑战， 支气管激发和猫房激发方案。这些受试者将从现有的 患者数据库或广告，并将在本核心中进行详细的基线评估，包括 对猫和其他常见环境过敏原的皮肤测试，肺活量测定，乙酰甲胆碱激发， 总IgE和过敏原特异性血清IgE水平以及组胺释放因子、血嗜碱性粒细胞 研究和猫过敏原的鼻攻击。符合入选和排除标准的患者， 将邀请参与其中一项或多项研究。第二组 患者包括已知对牛奶、鸡蛋或花生过敏的患者。他们还将从 现有的患者数据库或广告。他们的评估将包括对相关食品进行皮肤测试 过敏原和环境过敏原，肺量测定法，总IgE和过敏原特异性血清IgE测定 水平和组胺释放因子，血液嗜碱性粒细胞研究，双盲，安慰剂对照食物 对食物的挑战（S）。符合入选和排除标准的受试者，详见 将邀请方案参与食物挑战研究。 除了在招募和评估潜在研究受试者方面的作用外，该核心还将 对中心的患者安全和法规事务承担主要责任。为 为此，核心小组的人员中包括一名法规事务专家，他将定期与 主要研究者负责监督这些问题，并担任中心、IRB和 FDA.

This Cooperative Research Center proposal is unique in that the proposed projects will almost exclusively involve human subjects. To best accomplish these protocols, this Core has been established specifically for the purpose of recruiting potential subjects and performing screening evaluations to determine their eligibility for inclusion in these studies. The proposed projects will involve two distinct groups of patients. The first will focus on patients allergic to cat allergen, who will be included in the nasal challenge, bronchial challenge, and cat room challenge protocols. These subjects will be recruited either from existing patient databases or by advertisement and will undergo a detailed baseline evaluation in this Core, including skin testing to cat and other common environmental allergens, spirometry, methacholine challenge, measurement of total and allergen-specific serum IgE levels and histamine releasing factor, blood basophil studies, and nasal challenge with cat allergen. Those who meet the inclusion and exclusion criteria as detailed in the protocols will be invited to participate in one or more of those studies. The second group of patients will include those with a known allergy to milk, egg, or peanut. They will also be recruited from existing patient databases or by advertisement. Their evaluation will include skin testing to the relevant food allergen(s) and environmental allergens, spirometry, measurement of total and allergen-specific serum IgE levels and histamine releasing factor, blood basophil studies, and double-blind, placebo-controlled food challenges to the food(s) in question. Those who meet the inclusion and exclusion criteria as detailed in the protocol will be invited to participate in the food challenge study. In addition to its role in the recruitment and evaluation of potential study subjects, this Core will assume primary responsibility for the Center for issues regarding patient safety and regulatory affairs. For this reason, the Core's personnel include a regulatory affairs specialist who will meet regularly with the principal investigator to oversee these issues and serve as a liaison between the Center, the IRB, and the FDA.