Acute Lung Injury Clinical Trial
— ENDALIOfficial title:
Electronic Nicotine Delivery Devices and Potential Progression to Acute Lung Injury
This is an observational - data and specimen collection study. There have been increasing reports of vaping-induced lung injury, including severe lung injury and rare cases of death. The mechanism by which vaping contributes to lung injury in susceptible persons is unknown, as is impact on chronic lung disease. The investigators aim to identify individuals with chronic electronic nicotine delivery device (ENDD) exposure and matched controls within our ongoing cohort of HIV+ and HIV-uninfected individuals, collect PFT data, bank respiratory and stool samples and collect clinical data for studies of clinical risk, inflammation, biomarkers, and the microbiome in the identification and modification of risk of progression to lung injury or chronic pulmonary disease.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Men and women age 18 to 80 - Participant in a previous HLRC study, or a participant in the HIV PACT clinic or referred by a PACCM physician - At least weekly vape use over the past 3 months - OR No previous history of vape use and no current history of smoking tobacco for controls - negative pregnancy test (for women of child barring capabilities) Exclusion Criteria: - pregnancy or breast-feeding (urine pregnancy done on all females of child bearing potential- - - males and females who are at least 1 year post menopausal or surgically sterile will not be tested) - Contraindication to pulmonary function testing (i.e. abdominal or cataract surgery within 3 months, recent myocardial infarction, etc.). - Increasing respiratory symptoms or febrile (temperature >100.40F [380C]) within 4 weeks of study entry. - Acute cardiopulmonary issue in the past 4 months. - Uncontrolled hypertension at screening visit (systolic > 180 mm Hg or diastolic > 100 mm Hg) from an average of two or more readings. Subject may return for screening after blood pressure is controlled. - Active cancer requiring systemic chemotherapy or radiation. - Active infection of lungs, brain, or abdomen. - Intravenous drug use or alcohol use that will impair ability to complete study investigations in the opinion of the investigator. - subjects with an upper or lower respiratory tract infection - Persons who have tested positive for Covid 19 in the past 4 weeks. |
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh department of medicine division of Pulmonary, Allergy and Critical Care medicine | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in pulmonary function comparing vaping and non vaping participants (1) | The routine lung function endpoints of FVC, will be measured with the flow-volume loop recorder on a NDD Easy One Pro testing system. | Before bronchodilation | |
Primary | Difference in pulmonary function comparing vaping and non vaping participants (2) | The routine lung function endpoints of FEV1, will be measured with the flow-volume loop recorder on a NDD Easy One Pro testing system. | Before bronchodilation | |
Primary | Difference in pulmonary function comparing vaping and non vaping participants (3) | The routine lung function endpoints of FEV1/FVC, will be measured with the flow-volume loop recorder on a NDD Easy One Pro testing system. | Before bronchodilation | |
Primary | Difference in pulmonary function comparing vaping and non vaping participants (4) | The routine lung function endpoints of FEF25-75%, will be measured with the flow-volume loop recorder on a NDD Easy One Pro testing system. | Before bronchodilation | |
Primary | Difference in pulmonary function comparing vaping and non vaping participants (PB1) | The routine lung function endpoints of FVC, will be measured with the flow-volume loop recorder on a NDD Easy One Pro testing system. | within 10 minutes after bronchodilation | |
Primary | Difference in pulmonary function comparing vaping and non vaping participants (PB2) | The routine lung function endpoints of FEV1 will be measured with the flow-volume loop recorder on a NDD Easy One Pro testing system. | within 10 minutes after bronchodilation | |
Primary | Difference in pulmonary function comparing vaping and non vaping participants (PB3) | The routine lung function endpoints of FEV1/FVC, will be measured with the flow-volume loop recorder on a NDD Easy One Pro testing system. | within 10 minutes after bronchodilation | |
Primary | Difference in pulmonary function comparing vaping and non vaping participants (PB4) | The routine lung function endpoints of FEF25-75%, will be measured with the flow-volume loop recorder on a NDD Easy One Pro testing system. | within 10 minutes after bronchodilation | |
Primary | Difference in diffusion capacity comparing vaping and non vaping participants | The routine lung function diffusion lung capacity for carbon monoxide (DLCO) will be measured. | within 15 minutes after bronchodilation | |
Secondary | Change in inflammation | The investigators will determine inflammation in sputum peripheral cytokine responses | collected at one visit -will complete analysis in 2 years. | |
Secondary | Measurement of the inflammone in vaping and non vaping persons | The investigators will use this cohort to evaluate biomarkers (type to be determined) of inflammation to determine if the investigator can identify specific HIV vapors phenotypes using novel decision tree analyses. The investigator will examine relationship of the inflammatory signature associated with vaping | collection at one visit - will complete analysis in 2 years. | |
Secondary | comparison of microbial communities in stool | The investigators will use stool collected to compare bacterial function between vapers and non vapers | one stool collection at the subjects convenience - will complete analysis in 2 years. |
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