The Role of Macrophage Activation in Lung Injury Following Ozone Exposure

• Sponsor: Rutgers, The State University of New Jersey (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05794087
• Collaborator: National Institute of Environmental Health Sciences (NIEHS) (NIH)
• Enrollment: 120
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 51.7
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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. 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.

Condition or Disease	Intervention/Treatment	Phase
Air Pollution	Other: Clean Air; Other: Ozone	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Subjects will be randomly assigned to either clean air or ozone for the first exposure then crossed over to the alternate arm for the second exposure.Subjects will be randomly assigned to either clean air or ozone for the first exposure then crossed over to the alternate arm for the second exposure.
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: Subjects and laboratory personnel will not be informed of the type of exposure.
• Primary Purpose: Basic Science
• Official Title: Activated Macrophages and Ozone Toxicity II
• Actual Study Start Date: Feb 7, 2023
• Anticipated Primary Completion Date: Jun 1, 2027
• Anticipated Study Completion Date: Jun 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Clean Air, Then Ozone Subjects will be exposed to clean air for 3 hours at the first exposure visit and 0.2ppm ozone for 3 hours at the second exposure visit. The visits will be at least 2 weeks apart.	Other: Clean Air; Subjects will have the clean air exposure first, followed by the ozone exposure.; Other: Ozone; Subjects will have the ozone exposure first, followed by the clean air exposure.
Experimental: Ozone, Then Clean Air Subjects will be exposed to 0.2 ppm ozone for 3 hours at the first exposure visit and clean air for 3 hours at the second exposure visit. The visits will be at least 2 weeks apart.	Other: Clean Air; Subjects will have the clean air exposure first, followed by the ozone exposure.; Other: Ozone; Subjects will have the ozone exposure first, followed by the clean air exposure.

Outcome Measures

Primary Outcome Measures

1. Metabolic activity of inflammatory cells in induced sputum [Within 3 days of exposure]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rutgers - EOHSI	Piscataway	New Jersey	United States	08854

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Howard M Kipen, MD, Rutgers School of Public Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Howard M. Kipen, MD, MPH, Professor, Rutgers, The State University of New Jersey
• ClinicalTrials.gov Identifier: NCT05794087
• Other Study ID Numbers: Pro2022002024; R01ES004738
• First Posted: Mar 31, 2023
• Last Update Posted: Mar 31, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Howard M. Kipen, MD, MPH, Professor, Rutgers, The State University of New Jersey: Macrophage

Study Results

No Results Posted as of Mar 31, 2023