Endothelial DysfunctionEarly Phase 1NCT03479203

Acute Effects of E-Cigarette Aerosol Inhalation

A Early Phase 1 study testing Electronic Cigarette Aerosol in people with Endothelial Dysfunction and Biochemical Markers, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study comprises a portion of a larger study designed to compare results of vascular function in non-smokers to vascular function in healthy smokers chronically exposed to nicotinized electronic cigarette aerosol versus conventional cigarettes. Read more about this study

Who is it for?: Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for: Endothelial Dysfunction, Biochemical Markers
What is being tested?: Electronic Cigarette Aerosol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 1 siteUnited States
Study dates: 22 May 2018to 31 Aug 2022
Phase: Early Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 35 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

BMI of 18.5 - 30

Who cannot join

Cancer
HIV
Mental illness
Overt cardio- or neurovascular disease (prior heart attack, stroke, transient ischemic attacks)
Serious arrhythmias
Bronchospastic disease

Show all 9Show fewer

Upper respiratory tract infection within the past six weeks
Chronic medication or antibiotics
Claustrophobia / contraindications for MRI

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Acute and Long-term Effects of E-Cigarette Aerosol Inhalation on Biomarkers of Endothelial Function and Vascular Reactivity

Read the detailed description

Here, we 1) investigate the acute effects of non-nicotinized e-cigarette aerosol inhalation in nonsmokers in terms of blood-based markers of inflammation and oxidative stress, and 2) evaluate their association with hemodynamic-metabolic MRI parameters quantifying peripheral vascular reactivity, cerebrovascular reactivity, and aortic stiffness.

Conditions: Endothelial Dysfunction, Biochemical Markers
Being tested: Electronic Cigarette Aerosol
Keywords: Inflammation
Medical subject headings: Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Electronic Cigarette AerosolDrug
16 two-second-long puffs from a non-nicotinized electronic cigarette.

Study groups in NCT03479203
Study group	Role	What they receive
Healthy, Non-Smokers	Experimental	Non-nicotinized electronic cigarette aerosol (16 2-second long puffs) Receives: Drug: Electronic Cigarette Aerosol

What is being measured

The primary outcome is the main question the study is designed to answer.

Inflammatory Blood-Based Biomarkers
Post-vaping inflammation monitored by changes in an integrated cluster of blood-based biomarkers from serum/plasma of non-smoking healthy participants quantified at 0 and 120 min post-inhalation. The cluster consisted of: CRP, sICAM-1 in serum and HMGB1, ASC in plasma assayed using ELISA and quantified using absorbance-concentration curves generated by the manufacturers' standards; nitric oxide metabolites (nitrate + nitrite, NOx) in serum assayed with a nitrate/nitrite kit using a colorimetric standard provided by the manufacturer; reactive oxygen species (ROS) was quantified by using immortalized human pulmonary microvascular endothelial cells plated, prepared with serum, labeled with ROS dye and imaged confocal fluorescence microscopy.
The outcome measure was expressed as fold increase over pre-vaping values.
Measured: Participant blood draws occurred at two time points: 1) pre-vaping, 2) 120 minutes post-vaping. Inflammation index is calculated from the fold change in biomarker values over pre-vaping values
Acute Change in Aortic Pulse Wave Velocity Post-vaping
Central arterial stiffness was assessed using aortic pulse-wave velocity (PWV), a biomarker of aortic stiffness calculated by measuring the velocity of a pulse wave between two points in the same artery. A higher aortic pulse wave velocity equates to a stiffer aorta.
In each participant, aortic PWV was quantified, pre- and post-vaping, by dividing the path length of the aortic arch determined from a oblique sagittal image, by the transit time of the pulse pressure wave. Measurements obtained pre-vaping were compared to those obtained post-vaping.
Measured: PWV calculation occurred at two time points: 1) pre-vaping, 2) Fifteen minutes post-vaping.
Change in Femoral Artery Flow-Mediated Dilation Post-Vaping
Degree of dilation (% change in cross-sectional area) of femoral artery during hyperemia (the transient increase in blood flow velocity) after e-cigarette vaping as compared to before e-cigarette vaping.
Measured: Flow mediated dilation calculation occurred at two time points: 1) pre-vaping, 2) 40 minutes post-vaping.
Change in Washout Time Post-Vaping
Transit time of desaturated capillary blood from tissue to the imaging location after e-cigarette vaping
Measured: Washout time calculation occurred at two time points: 1) pre-vaping, and 2) 40 minutes post-vaping
Change in Upslope Post-Vaping
Tissue oxygen resaturation rate after e-cigarette vaping.
Measured: Upslope was calculated at two time points: 1) pre-vaping, and 2) 40 minutes post-vaping
Change in Overshoot Post-Vaping
Degree of overcompensatory effect post-vaping in the supply of oxygen after ischemia.
Measured: Overshoot was calculated at two time points: 1) pre-vaping, and 2) 40 minutes post-vaping.
Change in Breath Hold Index Post-Vaping
Rate of increase in blood flow velocity in the superior sagittal sinus from intermittent volitional apnea.
Measured: Breath hold index was calculated at two time points: 1) pre-vaping, 2) five minutes post-vaping.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 May 201831 Aug 2022

First posted27 Mar 2018
Study start22 May 2018
Primary completion31 Aug 2022
Study completion31 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe 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: Interventional
Phase: Early Phase 1
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03479203
Sponsor's protocol ID: 828195
Other IDs: R01HL139358
Status last verified: Apr 2024
First submitted: 28 Feb 2018
Last updated: 8 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Zamani P, Proto EA, Wilson N, Fazelinia H, Ding H, Spruce LA, Davila A Jr, Hanff TC, Mazurek JA, Prenner SB, Desjardins B, Margulies KB, Kelly DP, Arany Z, Doulias PT, Elrod JW, Allen ME, McCormack SE, Schur GM, D'Aquilla K, Kumar D, Thakuri D, Prabhakaran K, Langham MC, Poole DC, Seeholzer SH, Reddy R, Ischiropoulos H, Chirinos JA. Multimodality assessment of heart failure with preserved ejection fraction skeletal muscle reveals differences in the machinery of energy fuel metabolism. ESC Heart Fail. 2021 Aug;8(4):2698-2712. doi: 10.1002/ehf2.13329. Epub 2021 May 15.
PubMed 33991175
Langham MC, Caporale AS, Wehrli FW, Parry S, Schwartz N. Evaluation of Vascular Reactivity of Maternal Vascular Adaptations of Pregnancy With Quantitative MRI: Pilot Study. J Magn Reson Imaging. 2021 Feb;53(2):447-455. doi: 10.1002/jmri.27342. Epub 2020 Aug 25.
PubMed 32841482
Kligerman S, Raptis C, Larsen B, Henry TS, Caporale A, Tazelaar H, Schiebler ML, Wehrli FW, Klein JS, Kanne J. Radiologic, Pathologic, Clinical, and Physiologic Findings of Electronic Cigarette or Vaping Product Use-associated Lung Injury (EVALI): Evolving Knowledge and Remaining Questions. Radiology. 2020 Mar;294(3):491-505. doi: 10.1148/radiol.2020192585. Epub 2020 Jan 28.
PubMed 31990264
Chatterjee S, Caporale A, Tao JQ, Guo W, Johncola A, Strasser AA, Leone FT, Langham MC, Wehrli FW. Acute e-cig inhalation impacts vascular health: a study in smoking naive subjects. Am J Physiol Heart Circ Physiol. 2021 Jan 1;320(1):H144-H158. doi: 10.1152/ajpheart.00628.2020. Epub 2020 Nov 20.
PubMed 33216614
Wehrli FW, Caporale A, Langham MC, Chatterjee S. New Insights From MRI and Cell Biology Into the Acute Vascular-Metabolic Implications of Electronic Cigarette Vaping. Front Physiol. 2020 May 21;11:492. doi: 10.3389/fphys.2020.00492. eCollection 2020.
PubMed 32528311
Caporale A, Langham MC, Guo W, Johncola A, Chatterjee S, Wehrli FW. Acute Effects of Electronic Cigarette Aerosol Inhalation on Vascular Function Detected at Quantitative MRI. Radiology. 2019 Oct;293(1):97-106. doi: 10.1148/radiol.2019190562. Epub 2019 Aug 20.
PubMed 31429679
Chatterjee S, Tao JQ, Johncola A, Guo W, Caporale A, Langham MC, Wehrli FW. Acute exposure to e-cigarettes causes inflammation and pulmonary endothelial oxidative stress in nonsmoking, healthy young subjects. Am J Physiol Lung Cell Mol Physiol. 2019 Aug 1;317(2):L155-L166. doi: 10.1152/ajplung.00110.2019. Epub 2019 May 1.
PubMed 31042077
Caporale A, Lee H, Lei H, Rao H, Langham MC, Detre JA, Wu PH, Wehrli FW. Cerebral metabolic rate of oxygen during transition from wakefulness to sleep measured with high temporal resolution OxFlow MRI with concurrent EEG. J Cereb Blood Flow Metab. 2021 Apr;41(4):780-792. doi: 10.1177/0271678X20919287. Epub 2020 Jun 14.
PubMed 32538283

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Endothelial Dysfunction trials

Study at a glance

From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Acute and Long-term Effects of E-Cigarette Aerosol Inhalation on Biomarkers of Endothelial Function and Vascular Reactivity
ClinicalTrials.gov ID: NCT03479203
Acronym / sponsor ID: 828195
Conditions: Endothelial Dysfunction, Biochemical Markers
Keywords: Inflammation
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
Study start: 22 May 2018 (actual)
Primary completion: 31 Aug 2022 (actual)
Study completion: 31 Aug 2022 (actual)
First posted: 27 Mar 2018 (actual)
Results: Posted 8 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Healthy, Non-Smokers	Experimental	Drug: Electronic Cigarette AerosolNon-nicotinized electronic cigarette aerosol (16 2-second long puffs)

Who may qualify

Ages: 18 to 35 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

BMI of 18.5 - 30

Key exclusion criteria (9 listed)

Cancer
HIV
Mental illness
Overt cardio- or neurovascular disease (prior heart attack, stroke, transient ischemic attacks)
Serious arrhythmias

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Electronic Cigarette Aerosol16 two-second-long puffs from a non-nicotinized electronic cigarette.	Drug	Healthy, Non-Smokers

Primary outcome

Inflammatory Blood-Based Biomarkers
Time frame: Participant blood draws occurred at two time points: 1) pre-vaping, 2) 120 minutes post-vaping. Inflammation index is calculated from the fold change in biomarker values over pre-vaping values
Post-vaping inflammation monitored by changes in an integrated cluster of blood-based biomarkers from serum/plasma of non-smoking healthy participants quantified at 0 and 120 min post-inhalation. The cluster consisted of: CRP, sICAM-1 in serum and HMGB1, ASC in plasma assayed using ELISA and quantified using absorbance-concentration curves generated by the manufacturers' standards; nitric oxide metabolites (nitrate + nitrite, NOx) in serum assayed with a nitrate/nitrite kit using a colorimetric standard provided by the manufacturer; reactive oxygen species (ROS) was quantified by using immortalized human pulmonary microvascular endothelial cells plated, prepared with serum, labeled with ROS dye and imaged confocal fluorescence microscopy. The outcome measure was expressed as fold increase over pre-vaping values.
Acute Change in Aortic Pulse Wave Velocity Post-vaping
Time frame: PWV calculation occurred at two time points: 1) pre-vaping, 2) Fifteen minutes post-vaping.
Central arterial stiffness was assessed using aortic pulse-wave velocity (PWV), a biomarker of aortic stiffness calculated by measuring the velocity of a pulse wave between two points in the same artery. A higher aortic pulse wave velocity equates to a stiffer aorta. In each participant, aortic PWV was quantified, pre- and post-vaping, by dividing the path length of the aortic arch determined from a oblique sagittal image, by the transit time of the pulse pressure wave. Measurements obtained pre-vaping were compared to those obtained post-vaping.
Change in Femoral Artery Flow-Mediated Dilation Post-Vaping
Time frame: Flow mediated dilation calculation occurred at two time points: 1) pre-vaping, 2) 40 minutes post-vaping.
Degree of dilation (% change in cross-sectional area) of femoral artery during hyperemia (the transient increase in blood flow velocity) after e-cigarette vaping as compared to before e-cigarette vaping.
Change in Washout Time Post-Vaping
Time frame: Washout time calculation occurred at two time points: 1) pre-vaping, and 2) 40 minutes post-vaping
Transit time of desaturated capillary blood from tissue to the imaging location after e-cigarette vaping
Change in Upslope Post-Vaping
Time frame: Upslope was calculated at two time points: 1) pre-vaping, and 2) 40 minutes post-vaping
Tissue oxygen resaturation rate after e-cigarette vaping.
Change in Overshoot Post-Vaping
Time frame: Overshoot was calculated at two time points: 1) pre-vaping, and 2) 40 minutes post-vaping.
Degree of overcompensatory effect post-vaping in the supply of oxygen after ischemia.
Change in Breath Hold Index Post-Vaping
Time frame: Breath hold index was calculated at two time points: 1) pre-vaping, 2) five minutes post-vaping.
Rate of increase in blood flow velocity in the superior sagittal sinus from intermittent volitional apnea.

Results and safety

Results posted to the registry on 8 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy, Non-Smokers	31	31

Primary outcome: Inflammatory Blood-Based Biomarkers

Time frame: Participant blood draws occurred at two time points: 1) pre-vaping, 2) 120 minutes post-vaping. Inflammation index is calculated from the fold change in biomarker values over pre-vaping values. Mean (Standard Deviation). Unit: fold change

Measure	Healthy, Non-Smokers n = 31
Value	5 (0.5)

Healthy, Non-Smokers: Mean Difference (Final Values): 1.96 (95% CI 1 to 6), p = 0.05, t-test, 2 sided

Population analysed: For each participant, the fold change is obtained as as logarithmic fold increases over pre-vaping values, as: log2(fold change) = log2(expression value(s) of post-vape biomarker) - log2(expression value(s) of pre-vape biomarker). Data are expressed as means ± SD (5 - 18 nanograms per milliliter range) and two-tailed paired t tests were used to determine statistical significance.

Primary outcome: Acute Change in Aortic Pulse Wave Velocity Post-vaping

Time frame: PWV calculation occurred at two time points: 1) pre-vaping, 2) Fifteen minutes post-vaping.. Mean (Standard Deviation). Unit: Meters per second

Measure	Healthy, Non-Smokers n = 30
Value	0.19 (0.20)

Population analysed: Participants\* underwent an intervention which consisted of 16 3-second inhalations from a vaping device delivering non-nicotinized electronic cigarette aerosol. A quantitative magnetic resonance imaging scan was conducted pre- and post-vaping. Differences in aortic PWV before versus after e-cigarette vaping were assessed. \*One participant not analyzed due to discomfort during the scan.

Primary outcome: Change in Femoral Artery Flow-Mediated Dilation Post-Vaping

Time frame: Flow mediated dilation calculation occurred at two time points: 1) pre-vaping, 2) 40 minutes post-vaping.. Mean (Standard Deviation). Unit: percentage of change in cross-sectional

Measure	Healthy, Non-Smokers n = 30
Value	-3.20 (0.90)

Population analysed: Participants\* underwent an intervention which consisted of 16 3-second inhalations from a vaping device delivering non-nicotinized electronic cigarette aerosol. A quantitative magnetic resonance imaging scan was conducted pre- and post-vaping. Differences in flow mediated dilation before versus after e-cigarette vaping were assessed. \*One participant not analyzed due to discomfort during the scan.

Primary outcome: Change in Washout Time Post-Vaping

Time frame: Washout time calculation occurred at two time points: 1) pre-vaping, and 2) 40 minutes post-vaping. Mean (Standard Deviation). Unit: Seconds

Measure	Healthy, Non-Smokers n = 30
Value	-1.50 (0.30)

Population analysed: Participants underwent an intervention which consisted of 16 3-second inhalations from a vaping device delivering non-nicotinized electronic cigarette aerosol. A 50 minute quantitative magnetic resonance imaging protocol was conducted pre- and immediately post-vaping. (One participant not analyzed due discomfort with the cuff occlusion portion of the protocol.)

Adverse events

Time frame: Six Hours.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healthy, Non-Smokers	0 of 31 (0%)	0 of 31 (0%)	0 of 31

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 33991175Zamani P, Proto EA, Wilson N, Fazelinia H, Ding H, Spruce LA, Davila A Jr, Hanff TC, Mazurek JA, Prenner SB, Desjardins B, Margulies KB, Kelly DP, Arany Z, Doulias PT, Elrod JW, Allen ME, McCormack SE, Schur GM, D'Aquilla K, Kumar D, Thakuri D, Prabhakaran K, Langham MC, Poole DC, Seeholzer SH, Reddy R, Ischiropoulos H, Chirinos JA. Multimodality assessment of heart failure with preserved ejection fraction skeletal muscle reveals differences in the machinery of energy fuel metabolism. ESC Heart Fail. 2021 Aug;8(4):2698-2712. doi: 10.1002/ehf2.13329. Epub 2021 May 15.
Background: PubMed 32841482Langham MC, Caporale AS, Wehrli FW, Parry S, Schwartz N. Evaluation of Vascular Reactivity of Maternal Vascular Adaptations of Pregnancy With Quantitative MRI: Pilot Study. J Magn Reson Imaging. 2021 Feb;53(2):447-455. doi: 10.1002/jmri.27342. Epub 2020 Aug 25.
Background: PubMed 31990264Kligerman S, Raptis C, Larsen B, Henry TS, Caporale A, Tazelaar H, Schiebler ML, Wehrli FW, Klein JS, Kanne J. Radiologic, Pathologic, Clinical, and Physiologic Findings of Electronic Cigarette or Vaping Product Use-associated Lung Injury (EVALI): Evolving Knowledge and Remaining Questions. Radiology. 2020 Mar;294(3):491-505. doi: 10.1148/radiol.2020192585. Epub 2020 Jan 28.
Results publication: PubMed 33216614Chatterjee S, Caporale A, Tao JQ, Guo W, Johncola A, Strasser AA, Leone FT, Langham MC, Wehrli FW. Acute e-cig inhalation impacts vascular health: a study in smoking naive subjects. Am J Physiol Heart Circ Physiol. 2021 Jan 1;320(1):H144-H158. doi: 10.1152/ajpheart.00628.2020. Epub 2020 Nov 20.
Results publication: PubMed 32528311Wehrli FW, Caporale A, Langham MC, Chatterjee S. New Insights From MRI and Cell Biology Into the Acute Vascular-Metabolic Implications of Electronic Cigarette Vaping. Front Physiol. 2020 May 21;11:492. doi: 10.3389/fphys.2020.00492. eCollection 2020.
Results publication: PubMed 31429679Caporale A, Langham MC, Guo W, Johncola A, Chatterjee S, Wehrli FW. Acute Effects of Electronic Cigarette Aerosol Inhalation on Vascular Function Detected at Quantitative MRI. Radiology. 2019 Oct;293(1):97-106. doi: 10.1148/radiol.2019190562. Epub 2019 Aug 20.
Results publication: PubMed 31042077Chatterjee S, Tao JQ, Johncola A, Guo W, Caporale A, Langham MC, Wehrli FW. Acute exposure to e-cigarettes causes inflammation and pulmonary endothelial oxidative stress in nonsmoking, healthy young subjects. Am J Physiol Lung Cell Mol Physiol. 2019 Aug 1;317(2):L155-L166. doi: 10.1152/ajplung.00110.2019. Epub 2019 May 1.
Results publication: PubMed 32538283Caporale A, Lee H, Lei H, Rao H, Langham MC, Detre JA, Wu PH, Wehrli FW. Cerebral metabolic rate of oxygen during transition from wakefulness to sleep measured with high temporal resolution OxFlow MRI with concurrent EEG. J Cereb Blood Flow Metab. 2021 Apr;41(4):780-792. doi: 10.1177/0271678X20919287. Epub 2020 Jun 14.
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.

Felix W. Wehrli, PhD principal investigator

University of Pennsylvania

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Electronic Cigarette Aerosol in people with Endothelial Dysfunction and Biochemical Markers, run by University of Pennsylvania 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 1 inclusion and 9 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 8 May 2024. 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Inflammatory Blood-Based Biomarkers (time frame: Participant blood draws occurred at two time points: 1) pre-vaping, 2) 120 minutes post-vaping. Inflammation index is calculated from the fold change in biomarker values over pre-vaping values). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03479203, which also lists 8 linked publications.

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 8 May 2024.