Pathogenesis and Genetics of Environmental Asthma Ozone Study
The goals of the research are designed to accomplish genetic association studies of candidate genes in healthy normal individuals exposed to 0.2 ppm for 2.25 hours with intermittent exercise in order to search for associations between defined genotypes/haplotypes and 3 specific in vivo respiratory endpoints: a) change in FEV1 immediately after ozone exposure; b) change nonspecific bronchial reactivity as reflected in the change in methacholine PC20 FEV1 24 hours after ozone exposure ; and c) change in lung epithelial integrity as reflected in the Clearance Halftime of technetium 24 hours after ozone exposure. These studies have been carried forward to take place in 4 phases:
i) healthy individuals have been exposed to O3 using our standard exposure protocol; and we will increase the numbers of individuals available for study.
ii) perform genetic association studies for the endpoints of spirometry (FEV1, FVC, FEV1/FVC), PC20 FEV1 for methacholine, and epithelial integrity (Clearance Halftime) for 3 candidate O3 response genes taken from literature searches and/or previously characterized to demonstrate associations. These physiologic endpoints have been examined in terms of both a continuum of response, and discrete "responder" and "non-responder" endpoints.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Project 2: Genetic Regulation of Ozone Induced Inflammation in Humans.|
- Pathogenesis and genetics of environmental asthma ozone study [ Time Frame: acute and at 18 to 24 hour followup. ] [ Designated as safety issue: No ]Phenotype physiologic responses to ambient level of ozone exposure.
Biospecimen Retention: Samples With DNA
plasma, and ebc collected.
|Study Start Date:||July 2005|
|Study Completion Date:||June 2012|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00574158
|United States, North Carolina|
|W Michael Foster, PhD|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||W Michael Foster, PhD||Duke University|