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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05773001
Other study ID # Pro00110603
Secondary ID 1R01ES034350-01
Status Recruiting
Phase Phase 1
First received
Last updated
Start date May 18, 2023
Est. completion date May 2028

Study information

Verified date June 2024
Source Duke University
Contact Claudia Salazar
Phone 9196602026
Email claudia.salazar@duke.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date May 2028
Est. primary completion date May 2028
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Duke University Medical Center Durham North Carolina

Sponsors (3)

Lead Sponsor Collaborator
Robert Tighe, MD National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Other 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 Baseline, Day 18-20
Other Interactions between airway epithelial cells and immune cells o Interactions between airway epithelial cells and immune cells by RNA-sequencing to define an "interactome" Baseline, Day 18-20
Primary 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 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
Secondary Association between prior evidence of COVID pneumonia Association between prior evidence of COVID pneumonia, when compared to non-COVID infected individuals, and O3-induced inflammation Baseline, Day 18-20
Secondary Association between prior evidence of COVID infection without pneumonia Association between prior evidence of COVID infection without pneumonia, when compared to non-COVID infected individuals and O3-induced inflammation Baseline, Day 18-20
See also
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Not yet recruiting NCT04405921 - Hydroxychloroquine, Azithromycin in the Treatment of Covid-19 Phase 3
Completed NCT05465785 - A Clinical Trial of Immuno-bridging Between Different Manufacture Scales of Recombinant COVID-19 Vaccine (Sf9 Cell) N/A
Completed NCT04491240 - Evaluation of Safety and Efficiency of Method of Exosome Inhalation in SARS-CoV-2 Associated Pneumonia. Phase 1/Phase 2