Macrophage Regulation of Ozone-Induced Lung Inflammation

• Status: Not yet recruiting
• Trial end date: 2028-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research study to understand how prior respiratory infections affect the susceptibility to lung inflammation following environmental exposures.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Robert Tighe, MD
• Collaborators: National Institute of Environmental Health Sciences (NIEHS); National Institutes of Health (NIH)

Criteria

Inclusion Criteria:

• Individuals between 18-55 yrs. of age (No subject will be excluded from the study on the basis of gender or ethnicity)

• Individuals with knowledge of prior SARS-CoV-2 infection history allowing them to be segregated into one of three cohorts

• Cohort 1 - No history of SARS-CoV-2 infection (defined as no symptoms consisted with SARS-CoV-2 nor history of a positive SARS-CoV-2 test)

• Cohort 2 - Documented mild SARS-CoV-2 infection (a positive test, either PCR- or antigen-based) but with mild to no symptoms and no evidence of a lower respiratory tract infection (including no hospitalization, and no oxygen use)

• Cohort 3 - History of SARS-CoV-2 infection and symptoms/imaging consistent with a lower respiratory tract infection who have recovered, are >6 months out from their infection, and have normal lung function (spirometry with FVC, FEV1 and FEV1/FVC)

• There will be no maximal period from SARS-CoV-2 infection for inclusion in the study, the minimal period will be >6 months out from infection

Exclusion Criteria:

• Individuals with prior SARS-CoV-2 pneumonia who have ongoing respiratory symptoms, are still using supplemental oxygen, or have abnormal lung function

• Individuals with prior SARS-CoV-2 infection that cannot provide documentation of a positive test

• Current smokers of tobacco products including e-cigarettes or those with previous smoking history within the prior 5 years

• Pregnant women and women who are presently lactating.

• Subjects that have received antibiotic administration or an upper respiratory infection within the previous 4 weeks

• College and graduate students or employees who are under direct supervision by any of the investigators in this protocol

• Alcohol or illicit substance abuse

• Chronic cardio/pulmonary respiratory disorders or other medical conditions as determined by the investigator

• Increased airway hyperresponsiveness at baseline as measured by a positive methacholine challenge response (methacholine PC20 FEV1 < 4 mg/ml)

• Subjects will be requested to refrain from antihistamines, nonsteroidal anti-inflammatory agents, antioxidants (e.g. beta-carotene, selenium, and lutein) and supplemental vitamins (e.g. C and E), for 1 week prior to, and during testing.