Recruiting

Ozone Exposure

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT05794087

Conditions

Air Pollution

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Clean Air

Ozone

Study Details

Brief summary:

The purpose of the study is to better understand the mechanisms of lung injury from ozone exposure. Subjects will participate in two exposure sessions: filtered air and 0.2 ppm ozone. The exposure visits will be at least 2 weeks apart. Subjects will be asked to produce sputum through coughing after each exposure. The samples will be analyzed for macrophage activity.

Conditions

Air Pollution

Study ID

NCT05794087

Start date

Feb 7, 2023

Status verified date

Dec, 2025

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Exclusion Criteria:

  • Cardiovascular disease
  • Respiratory disease
  • Recent (within 4 weeks) respiratory or COVID-19 symptoms
  • Diabetes
  • Pregnancy
  • HIV Infection
  • History of smoking within the past 5 years.
  • Orthopedic or rheumatologic conditions which would interfere with cycle use
  • Inability to produce a sputum plug at screening
  • Daily use of antioxidant supplements, excluding those in a multivitamin. These supplements include Vitamin C or E, selenium, beta-carotene, lycopene, lutein, zeaxanthin and ginkgo biloba. Supplements taken less frequently but at least once a week will be reviewed by the principal investigator for eligibility determination.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Clean Air, Then Ozone

Subjects will be exposed to clean air for 3 hours at the first exposure visit and 0.2ppm ozone for 3 hours at the second exposure visit. The visits will be at least 2 weeks apart.

experimental: Ozone, Then Clean Air

Subjects will be exposed to 0.2 ppm ozone for 3 hours at the first exposure visit and clean air for 3 hours at the second exposure visit. The visits will be at least 2 weeks apart.

Interventions

Clean Air

Subjects will be exposed to clean air for 3 hours.

Ozone

Subjects will be exposed to 0.2 ppm ozone for 3 hours.

Primary outcome measure

  • Metabolic activity of inflammatory cells in induced sputum [ Time Frame: Within 3 days of exposure ]

Central Contacts and Locations

Central contacts

Kathleen Black, PhD

8484456049kgblack@eohsi.rutgers.edu

Adriana De Resende

848-445-0178ad998@eohsi.rutgers.edu

Locations

Rutgers - EOHSI

Recruiting

Piscataway, New Jersey, United States, 08854

Contacts

Kathy Black, PhD

848-445-6049kgblack@eohsi.rutgers.edu

Adriana De Resende

848-445-0178ad998@eohsi.rutgers.edu

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Dec 17, 2025

Last verified

Dec, 2025

Keywords

  • Macrophage

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2025-12-17.