Acute Lung InjuryENDALINCT05316727
Electronic Nicotine Delivery Devices and Potential Progression to Acute Lung Injury
An observational study of Acute Lung Injury and Pulmonary Injury, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Lung Injury, Pulmonary Injury, Electronic Cigarette Use
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2021to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh department of medicine division of Pulmonary, Allergy and Critical Care medicine
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the detailed description
Participants will be consented and undergo collection of data and specimens as listed below.
- Vaping use will be determined by history.
- No administration, dispensing or use of any vape product will take place as part of the study.
Experimental procedures:
Respiratory questionnaires and data review:
Detailed data regarding smoking history, illicit drug use, ART and other medications, and medical history are obtained using standardized questionnaires and medical record review. The Modified Medical Research Council Dyspnea scale (MMRC), the St. George's Questionnaire(SGQT), Pulmonary questionnaire (PQ) and a Vaping questionnaire will be administered. These are paper and pencil questionnaires that inquire about respiratory symptoms, quality of life, and other lung related issues. Laboratory data including CD4 cell counts and HIV viral levels are obtained from the medical record.
Blood Sample collection:
The subject will be asked to provide a blood sample by venipuncture of approximately 110mls (7.4 tablespoon) at this study visit. The purpose of this collection is to have blood processed for serum, plasma, and PBMCS, and a portion stored for RNA to be used for future use. A hemoglobin and carboxyhemoglobin will be done in order to calculate the DLCO. A CBC will be done to determine overall health and possible infections.
Saliva Collection: Participants will be asked to produce saliva and spit it into a sterile conical.
Stool collection: The investigator will ask participants to provide a stool sample. The subject will be instructed on how to collect a stool specimen at home. The investigator will give the subject instructions and a kit that will provide all the supplies needed to collect the stool and return it via mail at their convenience.
Lung function testing (PFT):
If a PFT was completed for a research study in the past month, that data will be used instead of repeating the test. The routine lung function endpoints of FVC, FEV1, FEV1/FVC, and FEF25-75% will be measured with the flow-volume loop recorder on a NDD Easy One Pro testing system before and after bronchodilator administration. The system is calibrated for body temperature and pressure of saturated gas and volumes, per American Thoracic Society (ATS) standards . DLco will be measured using the automated single-breath procedure of the integrated testing system, which conforms with ATS standards. All testing will be reviewed by a physician associated with this study. If any concerns or abnormal results are discovered during this testing, a member of the research team will notify the subject or the subject's primary care physician, who will assess the need to provide additional evaluation.
Pregnancy Test: A urine pregnancy test will be performed on all women of child bearing potential. Men, and women who are post menopausal for at least 1 year or have been surgically made sterile will not have a pregnancy test.
Collection of the vape product used by the subject. Declining participation in this collection does not mean the subject can't participate in the study.
The product will be sent to the investigators research labs for potential chemical analysis.
- Conditions
- Acute Lung Injury, Pulmonary Injury, Electronic Cigarette Use, Electronic Cigarette Related Lung Injury
- Keywords
- electronic nicotine delivery device (ENDD)
- Medical subject headings
- Acute Lung Injury, Lung Injury, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: within 15 minutes after bronchodilation
Secondary outcomes (3)
Change in inflammation
The investigators will determine inflammation in sputum peripheral cytokine responses
Measured: collected at one visit -will complete analysis in 2 years.
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
Measured: collection at one visit - will complete analysis in 2 years.
comparison of microbial communities in stool
The investigators will use stool collected to compare bacterial function between vapers and non vapers
Measured: one stool collection at the subjects convenience - will complete analysis in 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start15 Nov 2021
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lung InjuryStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Alison Morris, University of Pittsburgh
- Investigators
- Alison Morris, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05316727
- Sponsor's protocol ID
- STUDY20020151
- Other IDs
- 5R01HL140963-04
- Acronym
- ENDALI
- Status last verified
- Jan 2025
- First submitted
- 23 Feb 2022
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Nicotine Delivery Devices and Potential Progression to Acute Lung Injury
- ClinicalTrials.gov ID
- NCT05316727
- Acronym / sponsor ID
- ENDALI / STUDY20020151
- Conditions
- Acute Lung Injury, Pulmonary Injury, Electronic Cigarette Use, Electronic Cigarette Related Lung Injury
- Keywords
- electronic nicotine delivery device (ENDD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants will be consented and undergo collection of data and specimens as listed below.
- Vaping use will be determined by history.
- No administration, dispensing or use of any vape product will take place as part of the study.
Experimental procedures:
Respiratory questionnaires and data review:
Detailed data regarding smoking history, illicit drug use, ART and other medications, and medical history are obtained using standardized questionnaires and medical record review. The Modified Medical Research Council Dyspnea scale (MMRC), the St. George's Questionnaire(SGQT), Pulmonary questionnaire (PQ) and a Vaping questionnaire will be administered. These are paper and pencil questionnaires that inquire about respiratory symptoms, quality of life, and other lung related issues. Laboratory data including CD4 cell counts and HIV viral levels are obtained from the medical record.
Blood Sample collection:
The subject will be asked to provide a blood sample by venipuncture of approximately 110mls (7.4 tablespoon) at this study visit. The purpose of this collection is to have blood processed for serum, plasma, and PBMCS, and a portion stored for RNA to be used for future use. A hemoglobin and carboxyhemoglobin will be done in order to calculate the DLCO. A CBC will be done to determine overall health and possible infections.
Saliva Collection: Participants will be asked to produce saliva and spit it into a sterile conical.
Stool collection: The investigator will ask participants to provide a stool sample. The subject will be instructed on how to collect a stool specimen at home. The investigator will give the subject instructions and a kit that will provide all the supplies needed to collect the stool and return it via mail at their convenience.
Lung function testing (PFT):
If a PFT was completed for a research study in the past month, that data will be used instead of repeating the test. The routine lung function endpoints of FVC, FEV1, FEV1/FVC, and FEF25-75% will be measured with the flow-volume loop recorder on a NDD Easy One Pro testing system before and after bronchodilator administration. The system is calibrated for body temperature and pressure of saturated gas and volumes, per American Thoracic Society (ATS) standards . DLco will be measured using the automated single-breath procedure of the integrated testing system, which conforms with ATS standards. All testing will be reviewed by a physician associated with this study. If any concerns or abnormal results are discovered during this testing, a member of the research team will notify the subject or the subject's primary care physician, who will assess the need to provide additional evaluation.
Pregnancy Test: A urine pregnancy test will be performed on all women of child bearing potential. Men, and women who are post menopausal for at least 1 year or have been surgically made sterile will not have a pregnancy test.
Collection of the vape product used by the subject. Declining participation in this collection does not mean the subject can't participate in the study.
The product will be sent to the investigators research labs for potential chemical analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in pulmonary function comparing vaping and non vaping participants (1)
Time frame: Before bronchodilation
The routine lung function endpoints of FVC, will be measured with the flow-volume loop recorder on a NDD Easy One Pro testing system.
Difference in pulmonary function comparing vaping and non vaping participants (2)
Time frame: Before bronchodilation
The routine lung function endpoints of FEV1, will be measured with the flow-volume loop recorder on a NDD Easy One Pro testing system.
Difference in pulmonary function comparing vaping and non vaping participants (3)
Time frame: Before bronchodilation
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.
Difference in pulmonary function comparing vaping and non vaping participants (4)
Time frame: Before bronchodilation
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.
Difference in pulmonary function comparing vaping and non vaping participants (PB1)
Time frame: within 10 minutes after bronchodilation
The routine lung function endpoints of FVC, will be measured with the flow-volume loop recorder on a NDD Easy One Pro testing system.
Difference in pulmonary function comparing vaping and non vaping participants (PB2)
Time frame: within 10 minutes after bronchodilation
The routine lung function endpoints of FEV1 will be measured with the flow-volume loop recorder on a NDD Easy One Pro testing system.
Difference in pulmonary function comparing vaping and non vaping participants (PB3)
Time frame: within 10 minutes after bronchodilation
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.
Difference in pulmonary function comparing vaping and non vaping participants (PB4)
Time frame: within 10 minutes after bronchodilation
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.
Difference in diffusion capacity comparing vaping and non vaping participants
Time frame: within 15 minutes after bronchodilation
The routine lung function diffusion lung capacity for carbon monoxide (DLCO) will be measured.
3 secondary outcomes
Change in inflammation
Time frame: collected at one visit -will complete analysis in 2 years.
Measurement of the inflammone in vaping and non vaping persons
Time frame: collection at one visit - will complete analysis in 2 years.
comparison of microbial communities in stool
Time frame: one stool collection at the subjects convenience - will complete analysis in 2 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison Morris principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lung Injury and Pulmonary Injury, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in pulmonary function comparing vaping and non vaping participants (1) (time frame: Before bronchodilation). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.