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NCT Number: NCT05794087

The Role of Macrophage Activation in Lung Injury Following Ozone Exposure

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.

Recruiting

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Subjects will be asked to come to the Rutgers EOHSI clinical center (Piscataway, NJ) for 5 study visits. A physical exam to determine eligibility will be done at the first study visit. If the subject is healthy and able to produce a sputum sample, he/she will then be scheduled for 2 3-hour exposure visits, at least 2 weeks apart. One exposure will be to clean air and the other exposure will be to 0.2 ppm ozone. During the exposures, subjects will be requested to ride an exercise bicycle intermittently (approximately every 15 minutes). A follow-up visit for sputum collection will be scheduled either 24, 48, or 72 hours after each exposure visit. Blood and exhaled breath samples will also be collected at each visit.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clean air

Other

Subjects will be exposed to clean air for 3 hours.

Ozone

Other

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

Primary outcomes

  1. Metabolic activity of inflammatory cells in induced sputum

    Time frame: Within 3 days of exposure

    The metabolic activity of inflammatory cells in sputum will be assessed by the measurement of ATP production. The measurement will be made on an Agilent Seahorse using a Mitoplate Assay.

Study contacts

Contact information is provided by the study sponsor or research team.

Adriana De Resende

CONTACT

[email protected]

848-445-0178

Kathleen Black, PhD

CONTACT

[email protected]

8484456049

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • National Institute of Environmental Health Sciences (NIEHS)

Registry information

Official study title

Activated Macrophages and Ozone Toxicity II

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Mar 31, 2023
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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