Pathogenesis and Genetics of Environmental Asthma Ozone Study

Asthma Clinical Trial

Official title:

Project 2: Genetic Regulation of Ozone Induced Inflammation in Humans.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00574158
• Other study ID #: 12496-CP-004
• Secondary ID: ES012496
• Status: Completed
• Phase: N/A
• First received: December 14, 2007
• Last updated: September 25, 2014
• Start date: July 2005
• Est. completion date: June 2012

Study information

• Verified date: September 2014
• Source: National Institute of Environmental Health Sciences (NIEHS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: June 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Subjects with normal lung function values, and of normal body habitus (i.e., < BMI of 30);

• Do not have a history of lung disease, and not taking any medications for lung disease or other clinical disorders, and no prior or current smoking history.

Exclusion Criteria:

• Non-willingness to sign a consent form for participation.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma
• Inflammation

Locations

Country	Name	City	State
United States	W Michael Foster, PhD	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Environmental Health Sciences (NIEHS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathogenesis and genetics of environmental asthma ozone study	Phenotype physiologic responses to ambient level of ozone exposure.	acute and at 18 to 24 hour followup.	No