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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01ES034350-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Environmental Health Sciences (NIEHS) | NIH |
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The purpose of this research study to understand how prior respiratory infections affect the susceptibility to lung inflammation following environmental exposures.
Study participants will undergo a 1-day screening that includes a blood draw and breathing testing, return for a two-day series of testing to include blood draw, and brief breathing test before and after an inhaled challenge with either filtered air (FA) or ozone (O3). Participants return the next day for a brief breathing test, a blood draw and a procedure called bronchoscopy to evaluate the lung after the challenge.
Participants then return 18 - 20 days later to repeat the two-day series of testing to be challenged with the exposure not received on the first series, (FA or O3). Each visit will take about 3 - 3.5 hours. Follow-up phone calls from the study team will occur at 24 hours after each 2-day test series.
Total study duration is about one to one-and a half months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Other | no history of respiratory viral infection |
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| Cohort 2 | Other | Documented mild respiratory viral infection |
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| Cohort 3 | Other | Respiratory viral pneumonia |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ozone | Drug | Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing Ozone (O3). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, Day 18-20 |
| Association between prior evidence of respiratory viral pneumonia |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, Day 18-20 |
| Comparison between BAL immune cells and immune cells obtained from bronchial brushings |
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 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)
Cohort 3 - History of respiratory viral 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)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claudia Salazar | Contact | 9196602026 | claudia.salazar@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Robert Tighe, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Recruiting | Durham | North Carolina | 27710 | United States |
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| ID | Term |
|---|---|
| D010126 | Ozone |
| ID | Term |
|---|---|
| D010100 | Oxygen |
| D005740 | Gases |
| D007287 | Inorganic Chemicals |
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Association between prior evidence of respiratory viral pneumonia, when compared to non-infected individuals, and O3-induced inflammation |
| 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 | Baseline, Day 18-20 |
Comparison between BAL immune cells and immune cells obtained from bronchial brushings and the relationship to O3 induced inflammation and physiologic responses |
| 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" | Baseline, Day 18-20 |