Genetic Susceptibility TO Ozone-induced Airway Inflammation in Humans (GARBOZ)
This study is ongoing, but not recruiting participants.
Sponsor:
University of North Carolina, Chapel Hill
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: October 5, 2012
Last verified: October 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
Genetics Home Reference related topics:
Genetic Predisposition
MedlinePlus related topics:
Ozone
U.S. FDA Resources
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 2013 |
| Estimated Primary Completion Date: | September 2013 (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: | October 5, 2012 |
| 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 June 18, 2013