Status:
COMPLETED
Genetic Susceptibility TO Ozone-induced Airway Inflammation in Humans
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Environmental Protection Agency (EPA)
National Institute of Environmental Health Sciences (NIEHS)
Conditions:
Healthy Control
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
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 t...
Detailed Description
Sputum assessment day: Subjects meeting the required health status following the medical screening will be provided with a verbal and written description of all experimental procedures and possible ri...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2017
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00840528
Start Date
February 1 2002
End Date
June 20 2017
Last Update
September 25 2017
Active Locations (1)
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1
US EPA Human Studies Facility
Chapel Hill, North Carolina, United States, 27514