Pathogenesis and Genetics of Environmental Asthma Ozone Study

September 25, 2014 updated by: Michael Foster, National Institute of Environmental Health Sciences (NIEHS)

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

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

170

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • W Michael Foster, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Healthy adults, 18-35 y of age, both genders.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathogenesis and genetics of environmental asthma ozone study
Time Frame: acute and at 18 to 24 hour followup.
Phenotype physiologic responses to ambient level of ozone exposure.
acute and at 18 to 24 hour followup.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Environmental Health Sciences (NIEHS)

Investigators

  • Principal Investigator: W Michael Foster, PhD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

December 14, 2007

First Submitted That Met QC Criteria

December 14, 2007

First Posted (Estimate)

December 17, 2007

Study Record Updates

Last Update Posted (Estimate)

September 29, 2014

Last Update Submitted That Met QC Criteria

September 25, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12496-CP-004
  • ES012496

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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