Healthy Control Clinical Trial
— GARBOZOfficial title:
Genetic Susceptibility TO Ozone-induced Bronchial Airway Inflammatory Responses In Humans
Verified date | September 2017 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 84 |
Est. completion date | June 20, 2017 |
Est. primary completion date | June 20, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | US EPA Human Studies Facility | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | Environmental Protection Agency (EPA), National Institute of Environmental Health Sciences (NIEHS) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Airway neutrophilic response to ozone exposure | 6-24 hours post challenge | ||
Secondary | expression of specific genes of interest in a subset of ozone-responsive and ozone-non-responsive subjects | pre/ post exposure |
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