Epigenetic Effect Modifications With Ozone Exposure on Healthy Volunteers

Completed · Not applicable

Conditions studied: Exposure to Environmental Pollution, Non-occupational

In brief

The purpose of this protocol is to assess whether epigenetic factors in healthy individuals make a person more or less responsive to lung inflammation following ozone exposures.

Key facts

Study ID

NCT02469428

Run by

Environmental Protection Agency (EPA)

People needed

14

Starts

2013-12-01

Expected to finish

2018-11-05

Last updated by the study team

2019-07-30

Who can join

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

You may qualify if…

• Normal baseline 12-lead resting EKG.
• Normal lung function, defined by NHANES III as:
• FVC of > 80 %.
• FEV1 of > 80 %.
• FEV1/FVC ratio of > 80 %.
• Oxygen saturation of > 96 %.
• Ability to complete the exposure exercise regimen without reaching 80% of predicted maximal heart rate.

You may not qualify if…

• A history of acute and/or chronic illnesses such as diabetes, rheumatological diseases, immunodeficiency state, neurological disease, renal disease, liver disease, endocrinological disease, malignancy, cardiovascular disease, chronic respiratory diseases, and lung cancer.
• Asthma or a history of asthma.
• A Framingham risk score ≥10.
• Women who are pregnant, attempting to become pregnant, or breastfeeding.
• An allergy to any medications which may be used or prescribed in the course of this study.
• Cannot refrain from taking vitamins C or E (or multivitamins which contain Vitamins C or E) for 7 days prior to all visits.
• Cannot refrain from taking supplements for 7 days prior to all visits that contain homeopathic/naturopathic medicines or medications which may impact the results of the ozone challenge or interfere with any other medications potentially used in the study. Medications not specifically mentioned here may be reviewed by the investigators and medical staff prior to inclusion in the study.
• Untreated hypertension (≥ 150 systolic or ≥ 90 diastolic blood pressure).
• Dementia.
• Unspecified illnesses, which in the judgment of the investigator or medical staff might increase the risk associated ozone inhalation challenge or exercise.
• A history of skin allergies to adhesives used in securing EKG electrodes.
• Do not understand or speak English.
• Chronic and continuous allergic rhinitis.
• Unable to perform the moderate exercise required for the study.
• Those that are unwilling or unable to refrain from the following medications for the week prior to each exposure: anti-inflammatory agents such as ibuprofen, naproxen, or aspirin.
• Those currently taking or have taken anti-coagulant medication in the week prior to each exposure.
• Currently smoker or has a smoked within the last 2 years, or if you have a smoking history > 1 pack-years or are living with a smoker that smokes inside the house.
• A history of fainting in response to blood being drawn or other medical procedures.
• Unwilling or unable to stay for a suitable observation period after the procedure at the discretion of the physician involved, and not ride a bicycle or motorcycle home.
• You are unwilling or unable to refrain from strenuous exercise for 24 hours prior to and after all visits, consuming caffeine for 12 hours prior to all study visits, using of antihistamines for one week prior to exposures, and drinking alcohol 24 hours before all visits.
• Temporary exclusions:
• Viral upper respiratory tract infection or any acute infection within 6 weeks of bronchoscopy.
• Current exacerbation of allergic rhinitis and or use of antihistamines during one week prior to exposure.
• Recent or recurring exposure to pollutants or irritants.
• Exclusion criteria for bronchoscopy:

Where it is running

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

Full record on ClinicalTrials.gov

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