Understanding how respiratory infections affect lung inflammation from ozone exposure
Macrophage Regulation of Ozone-Induced Lung Inflammation
PHASE1 · Duke University · NCT05773001
This study is testing how past respiratory infections affect lung inflammation in people aged 18-55 when they are exposed to ozone.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Duke University (other) |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT05773001 on ClinicalTrials.gov |
What this trial studies
This research aims to investigate the impact of prior respiratory infections on lung inflammation susceptibility following ozone exposure. Participants aged 18-55 will undergo a series of tests, including blood draws and breathing tests, over a one-and-a-half-month period. They will be divided into cohorts based on their history of SARS-CoV-2 infection and will be challenged with either filtered air or ozone to evaluate their lung response. The study includes follow-up assessments to monitor participants' health after exposure.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18-55 with varying histories of SARS-CoV-2 infection.
Not a fit: Patients with no prior respiratory infections or those outside the age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of lung inflammation in individuals with a history of respiratory infections.
How similar studies have performed: Other studies have explored the effects of environmental exposures on lung health, but this specific approach focusing on SARS-CoV-2 infection history is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Durham, North Carolina
- Duke University Medical Center — Durham, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Robert Tighe, MD — Duke University
- Study coordinator: Claudia Salazar
- Email: claudia.salazar@duke.edu
- Phone: 9196602026
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: SARS-CoV-2 Pneumonia