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The Role of Macrophage Activation in Lung Injury Following Ozone Exposure

NCT ID: NCT05794087

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-07

Study Completion Date

2027-06-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Air Pollution

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Subjects will be randomly assigned to either clean air or ozone for the first exposure then crossed over to the alternate arm for the second exposure.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Subjects and laboratory personnel will not be informed of the type of exposure.

Study Groups

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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.

Group Type EXPERIMENTAL

Clean Air

Intervention Type OTHER

Subjects will be exposed to clean air for 3 hours.

Ozone

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Clean Air

Intervention Type OTHER

Subjects will be exposed to clean air for 3 hours.

Ozone

Intervention Type OTHER

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

Interventions

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Clean Air

Subjects will be exposed to clean air for 3 hours.

Intervention Type OTHER

Ozone

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Environmental Health Sciences (NIEHS)

NIH

Sponsor Role collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Howard M. Kipen, MD, MPH

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Howard M Kipen, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers School of Public Health

Locations

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Rutgers - EOHSI

Piscataway, New Jersey, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kathleen Black, PhD

Role: CONTACT

[email protected]
8484456049

Adriana De Resende

Role: CONTACT

[email protected]
848-445-0178

Facility Contacts

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Kathy Black, PhD

Role: primary

[email protected]
848-445-6049

Adriana De Resende

Role: backup

[email protected]
848-445-0178

Other Identifiers

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Pro2022002024

Identifier Type: -

Identifier Source: org_study_id

R01ES004738

Identifier Type: NIH

Identifier Source: secondary_id

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