Air Pollution Study: The Effect of Ozone on the Lung

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. 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. 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.

Official Title
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Activated Macrophages and Ozone Toxicity

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: 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

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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Clean Air<br>Subjects will be exposed to clean air for 3 hours. | Other: Clean Air<br>* Subjects will have the clean air exposure first, followed by the ozone exposure<br>|
| Experimental: Ozone<br>Subjects will be exposed to 0.2 ppm ozone for 3 hours. | Other: Ozone<br>* Subjects will have the ozone exposure first, followed by the clean air exposure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentrations of M1 and M2 Macrophages in the Sputum 24 Hours After Exposure. | The relative concentrations of M1 and M2 macrophages in the induced sputum sample will be assessed. | 24 hours after exposure. | 
| Concentrations of M1 and M2 Macrophages in the Sputum 48 Hours After Exposure. | The relative concentrations of M1 and M2 macrophages in the induced sputum sample will be assessed. | 48 hours after exposure | 
| Concentrations of M1 and M2 Macrophages in the Sputum 72 Hours After Exposure. | Relative concentrations of M1 and M2 macrophages in the induced sputum sample will be assessed. | 72 hours after exposure. | 

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