Air Pollution Study: The Effect of Ozone on the Lung

Air Pollution Clinical Trial

Official title:

Activated Macrophages and Ozone Toxicity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02673775
• Other study ID #: Pro20140001089
• Secondary ID: R01ES004738
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: June 7, 2022

Study information

• Verified date: September 2023
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: June 7, 2022
• Est. primary completion date: June 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Air Pollution

Intervention

Other:
• Clean Air
Subjects will have the clean air exposure first, followed by the ozone exposure
• Ozone
Subjects will have the ozone exposure first, followed by the clean air exposure

Locations

Country	Name	City	State
United States	Environmental and Occupational Health Sciences Institute	Piscataway	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Institute of Environmental Health Sciences (NIEHS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 hours after exposure.
Primary	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.	48 hours after exposure
Primary	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.	72 hours after exposure.