Core--Subject Characterization and Recruitment

Johns Hopkins University, Baltimore MD

Investigators

Linked publications & trials

Abstract

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