Pulmonary and Inflammatory Responses Following Exposure to a Low Concentration of Ozone or Clean Air

Description

Purpose: The primary purpose of this study is to measure pulmonary function, symptoms, and pulmonary inflammatory responses in healthy young adults during and immediately after exposure to a low concentration of ozone (0.070 ppm) or clean air for 6.6 hours while undergoing moderate intermittent exercise. This concentration is the current EPA NAAQS standard for ozone.

Conditions

Lung Injury, Acute, Symptoms and Signs, Neutrophilia Acute

Study Overview

Study Details

Study overview

Purpose: The primary purpose of this study is to measure pulmonary function, symptoms, and pulmonary inflammatory responses in healthy young adults during and immediately after exposure to a low concentration of ozone (0.070 ppm) or clean air for 6.6 hours while undergoing moderate intermittent exercise. This concentration is the current EPA NAAQS standard for ozone.

Pulmonary and Inflammatory Responses Following Exposure to a Low Concentration of Ozone or Clean Air for 6.6 Hours With Moderate Exercise in Healthy Young Adults

Pulmonary and Inflammatory Responses Following Exposure to a Low Concentration of Ozone or Clean Air

Condition
Lung Injury, Acute
Intervention / Treatment

-

Contacts and Locations

Chapel Hill

EPA Human Studies Facility, Chapel Hill, North Carolina, United States, 27599-7315

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Healthy men and women between 18 and 35 years of age.
  • 2. Physical conditions allowing sustained moderate exercise for 6.6 hours.
  • 3. Normal lung function (NHANES III):
  • 1. FVC \> 80 % of that predicted for gender, ethnicity, age and height.
  • 2. FEV1 \> 80 % of that predicted for gender, ethnicity, age and height.
  • 3. FEV1/FVC ratio \> 80 % of predicted values
  • 4. Oxygen saturation \> 94 %.
  • 5. Total symptom Score no greater than 20 (out of a possible 60-see accompanying score sheet) with a value no greater than 3 for any one score. No more than one score may be equal to 3.
  • 1. Individuals with a diagnosis of COVID-19 and/or hospitalized for COVID-19.
  • 2. Individuals who are not "up to date," \[meaning a person has received all recommended COVID-19 vaccines, including any booster dose(s) when eligible with their COVID vaccines as defined by the CDC.\]
  • 3. A history of acute and chronic cardiovascular disease, chronic respiratory disease, diabetes,rheumatologic diseases, immunodeficiency state.
  • 4. An acute respiratory illness within 4 weeks.
  • 5. Subjects who are asthmatic or have a history of asthma.
  • 6. Allergic to chemical vapors or gases.
  • 7. Any allergic symptoms during the time of participation in the study
  • 8. Female subjects who are currently pregnant, attempting to become pregnant or breastfeeding
  • 9. Subjects currently taking mega doses of vitamins and supplements, 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 (to include systemic steroids and beta blockers). Medications not specifically mentioned here may be reviewed by the investigators prior to a subject's inclusion in the study.
  • 10. Current and past smokers within 2 years, or subjects with a smoking history of at least a pack of cigarettes a day for more than 10 years over your lifetime. This includes vaping, hookah,and e-cigarettes.
  • 11. Uncontrolled hypertension (\> 140 systolic, \> 90 diastolic). Blood pressure readings equal to or greater that 140 Systolic and equal to or greater that 90 diastolic.
  • 12. Subjects who do not understand or speak English
  • 13. Unspecified illnesses, which in the judgment of the investigator might increase the risk associated with ozone inhalation challenge or exercise, will be a basis for exclusion.

Ages Eligible for Study

18 Years to 35 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Martin W. Case,

Andy Ghio, M.D., PRINCIPAL_INVESTIGATOR, EPA/ORD/CPHEA/PHITD/CRB

Study Record Dates

2025-02-01