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.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Program Projects (P01)
Project #
5P01HL103453-03
Application #
8478188
Study Section
Special Emphasis Panel (ZHL1-CSR-A)
Project Start
Project End
Budget Start
2013-07-01
Budget End
2014-06-30
Support Year
3
Fiscal Year
2013
Total Cost
$296,580
Indirect Cost
$107,675
Name
Cleveland Clinic Lerner
Department
Type
DUNS #
135781701
City
Cleveland
State
OH
Country
United States
Zip Code
44195
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