University of Louisville Research Foundation

Funding for Human Subjects Research:

DOE: Office of Biological and Environmental Research (OBER)

$49,052.00 (Est.) for: Fiscal Year 2006
Percent of funding associated with the use of human subjects: 0

Information on Use of Human Subjects:

This project does not involve the use of multiple protocols/subprojects.

Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: University of Louisville Research Foundation
Most recent approval: 03/21/05
IRB approval number: 693.04
Explanation of IRB approval:
Current approval received on 3/21/2005 is valid until 12/15/2006. Renewal submitted.

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 12
Reporting period for number of human subjects: Fiscal Year 2006

Type(s) of Human Subjects Involvement:

Collection of personally identifiable bodily materials (blood or blood products, urine, cells, tissue, teeth, organs, excreta, etc):

• Using bodily materials collected specifically for this project.

(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

Asthma remains a significant health problem in the pediatric population affecting approximately 7 percent of children less than 18 years of age in the United States. In the Louisville metro area alone, an estimated 13,000 children are affected by this increasingly common condition. Although the precise etiology of asthma remains unknown, it is now recognized that both genetic predisposition and environmental exposure to a number of chemical and/or infectious agents may be operative in the onset, persistence, and exacerbation of the clinical asthma phenotype. The goal of this project is to identify candidate urinary proteins that may serve as predictors of disease onset and treatment compliance in children exposed to environmental toxins and treated with inhaled corticosteroids, respectively. The primary objective of this investigation is to characterize the urinary proteome in children (1) in the Rubbertown industrial area of West Louisville and (2) prior to and during treatment with inhaled corticosteroid therapy. The central hypothesis of this proposal is that the urinary protein expression pattern differs as a function of environment and inhaled corticosteroid treatment.