Air Pollution Study: The Effect of Ozone on the Lung

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2022-06-07

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.

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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.

Conditions

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Air Pollution

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Clean Air

Subjects will be exposed to clean air for 3 hours.

Group Type PLACEBO_COMPARATOR

Clean Air

Intervention Type OTHER

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

Ozone

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

Group Type EXPERIMENTAL

Ozone

Intervention Type OTHER

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

Interventions

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Clean Air

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

Intervention Type OTHER

Ozone

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

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes