The Role of Macrophage Activation in Lung Injury Following Ozone Exposure

Air Pollution Clinical Trial

Official title:

Activated Macrophages and Ozone Toxicity II

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05794087
• Other study ID #: Pro2022002024
• Secondary ID: R01ES004738
• Status: Recruiting
• Phase: N/A
• Start date: February 7, 2023
• Est. completion date: June 1, 2027

Study information

• Verified date: March 2023
• Source: Rutgers, The State University of New Jersey
• Contact: Kathleen Black, PhD
• Phone: 8484456049
• Email: kgblack[@]eohsi.rutgers.edu
• 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 1, 2027
• Est. primary completion date: June 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Vaccinated against COVID-19

Exclusion Criteria:

• Cardiovascular disease
• Respiratory disease
• Recent (within 4 weeks) respiratory or COVID-19 symptoms
• Diabetes
• Pregnancy
• HIV Infection
• History of smoking within the past 5 years.
• Orthopedic or rheumatologic conditions which would interfere with cycle use
• Inability to produce a sputum plug at screening
• Daily use of antioxidant supplements, excluding those in a multivitamin. These supplements include Vitamin C or E, selenium, beta-carotene, lycopene, lutein, zeaxanthin and ginkgo biloba. Supplements taken less frequently but at least once a week will be reviewed by the principal investigator for eligibility determination.

Related Conditions & MeSH terms

• Air Pollution

Intervention

Other:
• Clean Air
Subjects will be exposed to clean air for 3 hours.
• Ozone
Subjects will be exposed to 0.2 ppm ozone for 3 hours.

Locations

Country	Name	City	State
United States	Rutgers - EOHSI	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	Metabolic activity of inflammatory cells in induced sputum	The metabolic activity of inflammatory cells in sputum will be assessed by the measurement of ATP production. The measurement will be made on an Agilent Seahorse using a Mitoplate Assay.	Within 3 days of exposure