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: July 16, 2015
Last verified: June 2015
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 2016 (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
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
|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
||July 16, 2015
||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 August 27, 2015
Genetic Predisposition to Disease