Air Pollution Study: The Effect of Ozone on the Lung

Rutgers The State University of New Jersey

Status: Completed

Conditions: Air Pollution

Treatments: Other: Clean Air; Other: Ozone

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02673775

R01ES004738 (U.S. NIH Grant/Contract)

Pro20140001089

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 135 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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135 participants in 2 patient groups, including a placebo group

Clean Air

Placebo Comparator group

Description:

Subjects will be exposed to clean air for 3 hours.

Treatment:

Other: Clean Air

Ozone

Experimental group

Description:

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

Treatment:

Other: Ozone