The Role of Macrophage Activation in Lung Injury Following Ozone Exposure

Study Overview
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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.

Official Title
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Activated Macrophages and Ozone Toxicity II

Conditions
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Air Pollution

Intervention / Treatment
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* Other: Clean Air
* Other: Ozone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Vaccinated against COVID-19 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clean Air, Then Ozone<br>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. | Other: Clean Air<br>* Subjects will be exposed to clean air for 3 hours.<br>Other: Ozone<br>* Subjects will be exposed to 0.2 ppm ozone for 3 hours.<br>|
| Experimental: Ozone, Then Clean Air<br>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. | Other: Clean Air<br>* Subjects will be exposed to clean air for 3 hours.<br>Other: Ozone<br>* Subjects will be exposed to 0.2 ppm ozone for 3 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic activity of inflammatory cells in induced sputum | 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. | Within 3 days of exposure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Macrophage