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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
David B. Peden, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00840528
First received: February 6, 2009
Last updated: December 9, 2013
Last verified: December 2013
  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: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2002
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: ozone
    0.4 ppm ozone for 2 hours
    Other Name: O3
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
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

No publications provided

Responsible Party: David B. Peden, MD, Professor of Pediatrics, Director of CEMALB, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00840528     History of Changes
Other Study ID Numbers: 02-1416, NIH/NIEHS 1RC1ES018417
Study First Received: February 6, 2009
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

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

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

ClinicalTrials.gov processed this record on April 14, 2014