Electronic Nicotine Delivery Devices and Potential Progression to Acute Lung Injury

NCT05316727 | Completed

• 2 other identifiers: STUDY200201515R01HL140963-04
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Lung Injury; Pulmonary Injury; Electronic Cigarette Use; Electronic Cigarette Related Lung Injury

Keywords

electronic nicotine delivery device (ENDD)

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (3)

• Change in inflammation

  collected at one visit -will complete analysis in 2 years.

• Measurement of the inflammone in vaping and non vaping persons

  collection at one visit - will complete analysis in 2 years.

• comparison of microbial communities in stool

  one stool collection at the subjects convenience - will complete analysis in 2 years.

Study Arms (2)

Vaping

At least weekly vape use over the past 3 months of the subjects unspecified product

Non vapers

No previous history of vape use and no current history of smoking tobacco for controls

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The investigators will leverage resources from an ongoing cohort of people living with HIV (PLWH) and HIV-uninfected community dwelling individuals as well as a growing dataset of individuals hospitalized with EVALI. individuals, males or females in all races, ethnicities, and socioeconomic backgrounds greater than 18 years of age.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Pittsburgh department of medicine division of Pulmonary, Allergy and Critical Care medicine

Pittsburgh, Pennsylvania, 15213, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Stool, oral wash, sputum

MeSH Terms

Conditions

Acute Lung Injury; Lung Injury; Vaping

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Thoracic Injuries; Wounds and Injuries; Smoking; Behavior

Study Officials

• Alison Morris

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: April 7, 2022
• Study Start: November 15, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)