Macrophage Regulation of Ozone-Induced Lung Inflammation

ConditionRespiratory Viral Infection

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-55

SponsorRobert Tighe, MD

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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 respiratory viral infection history allowing them to be segregated into one of three cohorts

Cohort 1 - No history of respiratory viral infection (defined as no symptoms consistent with respiratory viral infection nor history of a positive respiratory viral test)

Cohort 2 - Documented mild respiratory viral 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)

Disqualifiers

Individuals with prior respiratory viral pneumonia who have ongoing respiratory symptoms, are still using supplemental oxygen, or have abnormal lung function

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

Trial design

Design model

Crossover

Treatments tested in this trial

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

Treatment groups

100 Participants

are divided into 3 treatment groups

Group A: Cohort 1Other 1 intervention

Group B: Cohort 2Other 1 intervention

Group C: Cohort 3Other 1 intervention

Trial outcomes

Primary outcomes

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)

Time frame

Baseline, Day 18-20

Secondary outcomes

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

Change in the abundance of autonomous CSF-1 expression in alveolar macrophages and association to measures of O3-induced inflammation

Time frame

Baseline, Day 18-20

Association between prior evidence of respiratory viral pneumonia

Association between prior evidence of respiratory viral pneumonia, when compared to non-infected individuals, and O3-induced inflammation

Time frame

Baseline, Day 18-20

Association between prior evidence of respiratory viral infection without pneumonia

Association between prior evidence of respiratory viral infection without pneumonia, when compared to non-infected individuals and O3-induced inflammation

Time frame

Baseline, Day 18-20

Other outcomes

Change in composition of BAL immune cells following O3 exposure

Change in composition of BAL immune cells following O3 exposure will identify unique immune cells driving inflammation and physiologic responses

Time frame

Baseline, Day 18-20

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

Comparison between BAL immune cells and immune cells obtained from bronchial brushings and the relationship to O3 induced inflammation and physiologic responses

Time frame

Baseline, Day 18-20

Interactions between airway epithelial cells and immune cells

Interactions between airway epithelial cells and immune cells by RNA-sequencing to define an "interactome"

Time frame

Baseline, Day 18-20

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Robert Tighe, MD

Lead sponsor

Duke University

Sponsor institution

National Institutes of Health (NIH)

Collaborator

National Institute of Environmental Health Sciences (NIEHS)

Collaborator

Source ClinicalTrials.gov

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