Pathogenesis and Genetics of Environmental Asthma Ozone Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Foster, National Institute of Environmental Health Sciences (NIEHS)
ClinicalTrials.gov Identifier:
NCT00574158
First received: December 14, 2007
Last updated: September 25, 2014
Last verified: September 2014
  Purpose

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.


Condition
Asthma
Inflammation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Project 2: Genetic Regulation of Ozone Induced Inflammation in Humans.

Resource links provided by NLM:


Further study details as provided by National Institute of Environmental Health Sciences (NIEHS):

Primary Outcome Measures:
  • 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.


Enrollment: 170
Study Start Date: July 2005
Study Completion Date: June 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00574158

Locations
United States, North Carolina
W Michael Foster, PhD
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Investigators
Principal Investigator: W Michael Foster, PhD Duke University
  More Information

No publications provided

Responsible Party: Michael Foster, Professor, National Institute of Environmental Health Sciences (NIEHS)
ClinicalTrials.gov Identifier: NCT00574158     History of Changes
Other Study ID Numbers: 12496-CP-004, ES012496
Study First Received: December 14, 2007
Last Updated: September 25, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institute of Environmental Health Sciences (NIEHS):
ozone
inflammatory airway disease
polymorphisms

Additional relevant MeSH terms:
Asthma
Inflammation
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 30, 2014