RECRUITING

Macrophage Regulation of Ozone-Induced Lung Inflammation

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Macrophage Regulation of Ozone-Induced Lung Inflammation

Quick Facts

Study Start:2023-05-18

Study Completion:2028-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05773001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Claudia Salazar

CONTACT

9196602026

claudia.salazar@duke.edu

Principal Investigator

Robert Tighe, MD

PRINCIPAL_INVESTIGATOR

Duke University

Study Locations (Sites)

Duke University Medical Center

Durham, North Carolina, 27710

United States

Collaborators and Investigators

Sponsor: Robert Tighe, MD

Robert Tighe, MD, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-18

Study Completion Date2028-05

Study Record Updates

Study Start Date2023-05-18

Study Completion Date2028-05

Terms related to this study

Additional Relevant MeSH Terms

SARS-CoV-2 Pneumonia