Genetic Susceptibility TO Ozone-induced Airway Inflammation in Humans

Completed · Not applicable

Conditions studied: Healthy Control

In brief

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

Key facts

Study ID

NCT00840528

Run by

University of North Carolina, Chapel Hill

People needed

84

Starts

2002-02-01

Expected to finish

2017-06-20

Last updated by the study team

2017-09-25

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• US EPA Human Studies Facility — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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