Air Pollution Study: The Effect of Ozone on the Lung

Rutgers, The State University of New Jersey135 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

135

Conditions

Air Pollution

Interventions

Clean AirOTHER

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

OzoneOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Environmental and Occupational Health Sciences Institute

Piscataway, New Jersey, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 72 hours after exposure.

Data from ClinicalTrials.gov

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