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
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: 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 October 23, 2014