NCT05794087

The Role of Macrophage Activation in Lung Injury Following Ozone Exposure

Activated Macrophages and Ozone Toxicity II

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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. The exposure visits will be at least 2 weeks apart. 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, at least 2 weeks apart. 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 and exhaled breath samples will also be collected at each visit.

Conditions

• Air Pollution

Interventions

Type	Name	Description
OTHER	Clean Air	Subjects will be exposed to clean air for 3 hours.
OTHER	Ozone	Subjects will be exposed to 0.2 ppm ozone for 3 hours.

Timeline

• Start date: 2023-02-07
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2023-03-31
• Last updated: 2025-12-17

Locations

1 site across 1 country: United States