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Completed

NCT Number: NCT02673775

Air Pollution Study: The Effect of Ozone on the Lung

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. Subjects will be asked to produce sputum through coughing after each exposure. The samples will be analyzed for macrophage activity.

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Key information

Conditions

Air Pollution

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Environmental and Occupational Health Sciences Institute

Piscataway, New Jersey, 08854, United States

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. 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, urine, 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.

Inclusion criteria

  • Healthy men and women

Exclusion criteria

  • Cardiovascular disease
  • Respiratory disease
  • Diabetes
  • Pregnancy
  • HIV infection
  • History of smoking within the last 5 years
  • Daily use of antioxidant supplements (e.g., Vitamin C/E, selenium, beta-carotene, lycopene, lutein, zeaxanthin, or ginkgo biloba)
  • Orthopedic or rheumatological conditions that would interfere with cycle use

Treatment and study plan

Clean air

Other

Subjects will have the clean air exposure first, followed by the ozone exposure

Ozone

Other

Subjects will have the ozone exposure first, followed by the clean air exposure

Primary outcomes

  1. Concentrations of M1 and M2 Macrophages in the Sputum 24 Hours After Exposure.

    Time frame: 24 hours after exposure.

    The relative concentrations of M1 and M2 macrophages in the induced sputum sample will be assessed.

  2. Concentrations of M1 and M2 Macrophages in the Sputum 48 Hours After Exposure.

    Time frame: 48 hours after exposure

    The relative concentrations of M1 and M2 macrophages in the induced sputum sample will be assessed.

  3. Concentrations of M1 and M2 Macrophages in the Sputum 72 Hours After Exposure.

    Time frame: 72 hours after exposure.

    Relative concentrations of M1 and M2 macrophages in the induced sputum sample will be assessed.

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

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Feb 4, 2016
Registry last updated
Sep 25, 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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