Macrophage Regulation of Ozone-Induced Lung Inflammation

NCT05773001 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: Pro001106031R01ES034350-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

SARS-CoV-2 Pneumonia

Outcome Measures

Primary Outcomes (1)

• Change in the abundance of monocyte-derived alveolar macrophages

  \- Change in the abundance of monocyte-derived alveolar macrophages and association to measures of O3-induced inflammation (BAL cell neutrophils, albumin and cytokine production)

  Baseline, Day 18-20

Secondary Outcomes (3)

• Change in the abundance of autonomous CSF-1 expression in alveolar macrophages

  Baseline, Day 18-20

• Association between prior evidence of COVID pneumonia

  Baseline, Day 18-20

• Association between prior evidence of COVID infection without pneumonia

  Baseline, Day 18-20

Other Outcomes (3)

• Change in composition of BAL immune cells following O3 exposure

  Baseline, Day 18-20

• Comparison between BAL immune cells and immune cells obtained from bronchial brushings

  Baseline, Day 18-20

• Interactions between airway epithelial cells and immune cells

  Baseline, Day 18-20

Study Arms (3)

Cohort 1

OTHER

No history of SARS-CoV-2

Drug: Ozone

Cohort 2

OTHER

Documented mild SARS-CoV-2 infection

Drug: Ozone

Cohort 3

OTHER

SARS-CoV-2 pneumonia

Drug: Ozone

Interventions

Ozone DRUG

Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing Ozone (O3).

Also known as: O3

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Robert Tighe, MD: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Environmental Health Sciences (NIEHS): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Interventions

Ozone

Intervention Hierarchy (Ancestors)

Oxygen; Gases; Inorganic Chemicals

Study Officials

• Robert Tighe, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudia Salazar

CONTACT

9196602026; claudia.salazar@duke.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 17, 2023
• Study Start: May 18, 2023
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)