Air Pollution Study: The Effect of Ozone on the Lung

Not Applicable

Completed

• Conditions: Air Pollution
• Interventions: Other: Clean Air; Other: Ozone

• Registration Number: NCT02673775
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief Summary

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

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 Timeline

• Study First Submitted: 2016-01-29
• Study Start: 2016-02
• Study First Submitted QC: 2016-02-01
• Study First Posted: 2016-02-04
• Primary Completion: 2022-06-07
• Study Completion: 2022-06-07
• Results First Submitted: 2023-07-17
• Status Verified: 2023-09
• Results First Submitted QC: 2023-09-18
• Last Update Submitted: 2023-09-18
• Results First Posted: 2023-10-11
• Last Update Posted: 2023-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Clean Air	Clean Air	Subjects will be exposed to clean air for 3 hours.
Ozone	Ozone	Subjects will be exposed to 0.2 ppm ozone for 3 hours.

Primary Outcome Measures

Name	Time	Method
Concentrations of M1 and M2 Macrophages in the Sputum 72 Hours After Exposure.	72 hours after exposure.	Relative concentrations of M1 and M2 macrophages in the induced sputum sample will be assessed.
Concentrations of M1 and M2 Macrophages in the Sputum 24 Hours After Exposure.	24 hours after exposure.	The relative concentrations of M1 and M2 macrophages in the induced sputum sample will be assessed.
Concentrations of M1 and M2 Macrophages in the Sputum 48 Hours After Exposure.	48 hours after exposure	The relative concentrations of M1 and M2 macrophages in the induced sputum sample will be assessed.

Trial Locations

Locations (1)

Environmental and Occupational Health Sciences Institute; 🇺🇸 Piscataway, New Jersey, United States