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Genetic Susceptibility TO Ozone-induced Airway Inflammation in Humans (GARBOZ)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00840528
First Posted: February 10, 2009
Last Update Posted: September 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Environmental Protection Agency (EPA)
National Institute of Environmental Health Sciences (NIEHS)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
  Purpose
The principal purpose of this study is to identify hyper-responsive, responsive and non-responsive groups of healthy human subjects based on their airway neutrophilic response to ozone exposure, and to perform micro-array analyses on DNA collected from recovered airway cells to explore possible differences in gene expression profiles between the three groups

Condition Intervention
Healthy Control Other: ozone

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Genetic Susceptibility TO Ozone-induced Bronchial Airway Inflammatory Responses In Humans

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Airway neutrophilic response to ozone exposure [ Time Frame: 6-24 hours post challenge ]

Secondary Outcome Measures:
  • expression of specific genes of interest in a subset of ozone-responsive and ozone-non-responsive subjects [ Time Frame: pre/ post exposure ]

Enrollment: 84
Study Start Date: February 2002
Study Completion Date: June 20, 2017
Primary Completion Date: June 20, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ozone exposure
Exposure to ozone at 0.4ppm
Other: ozone
0.4 ppm ozone for 2 hours
Other Name: O3

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects will have an FEV1/FVC equal to or greater than 75%, as well as FVC and FEV1 greater than or equal to 80% of predicted normal for height and age.
  • Skin testing will be performed; subjects with active allergies will not be studied while they are symptomatic.
  • Subjects must be in good general health with no history of acute or chronic cardiovascular disease, chronic respiratory disease, and acute respiratory illness within 4 weeks, and without contraindications for performing sustained light to moderate exercise.
  • Subjects must demonstrate the ability to produce an acceptable induced sputum sample during the training session. If the sample is unsatisfactory, the subject's participation will end at this point.
  • Antidepressants and other medications may be permitted if in the opinion of the investigator the medication will not interfere with the study procedures or compromise safety; and if the dosage has been stable for 3 months.
  • Subjects must smoke less than 10 cigarettes (one half pack) a month for at least 3 years. Individuals who have smoked greater than 10 pack years lifetime will be excluded.
  • Subjects must be willing to refrain from strenuous physical activity for 24 hours before and after exposure.

Exclusion Criteria:

  • asthmatic or active allergic rhinitis
  • Non English speaking volunteers will be excluded as no one on the study staff is fluent in other languages likely to be encountered.
  • use anti-inflammatory medications or medications for asthma
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00840528


Locations
United States, North Carolina
US EPA Human Studies Facility
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Environmental Protection Agency (EPA)
National Institute of Environmental Health Sciences (NIEHS)
Investigators
Principal Investigator: David B Peden, MD, MS University of North Carolina at Chapel Hill, Dept of Pediatrics / Center for Environmental Medicine, Asthma and Lung Biology
  More Information

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00840528     History of Changes
Other Study ID Numbers: 02-1416
NIH/NIEHS 1RC1ES018417 ( Other Grant/Funding Number: NIEHS & EPA )
First Submitted: February 6, 2009
First Posted: February 10, 2009
Last Update Posted: September 25, 2017
Last Verified: September 2017

Keywords provided by University of North Carolina, Chapel Hill:
ozone

Additional relevant MeSH terms:
Disease Susceptibility
Genetic Predisposition to Disease
Disease Attributes
Pathologic Processes