Genetic Susceptibility TO Ozone-induced Airway Inflammation in Humans (GARBOZ)
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
David B. Peden, MD, University of North Carolina, Chapel Hill
First received: February 6, 2009
Last updated: December 9, 2013
Last verified: December 2013
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
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
||Genetic Susceptibility TO Ozone-induced Bronchial Airway Inflammatory Responses In Humans
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||September 2015 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 40 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00840528
|US EPA Human Studies Facility
|Chapel Hill, North Carolina, United States, 27514 |
University of North Carolina, Chapel Hill
||David B Peden, MD, MS
||University of North Carolina at Chapel Hill, Dept of Pediatrics / Center for Environmental Medicine, Asthma and Lung Biology
No publications provided
||David B. Peden, MD, Professor of Pediatrics, Director of CEMALB, University of North Carolina, Chapel Hill
History of Changes
|Other Study ID Numbers:
||02-1416, NIH/NIEHS 1RC1ES018417
|Study First Received:
||February 6, 2009
||December 9, 2013
||United States: Institutional Review Board
United States: Federal Government
Keywords provided by University of North Carolina, Chapel Hill:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 12, 2013