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NCT02783768 · ClinicalTrials.gov registry record · Early Phase 1
Ventilation and Pulmonary Endothelium Toxicities of E-cigarettes: A Randomized Crossover Pilot Study
A Early Phase 1 study, sponsored by Columbia University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 12
- Enrollment target
NCT02783768: Completed Early Phase 1 study, sponsored by Columbia University.
NCT02783768 is a Early Phase 1 study that has completed, run by Columbia University. The registered enrollment target is 12 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02783768, a Early Phase 1 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
Determination of the acute pulmonary toxicities of e-cigarettes in young adults is of major public health importance, as e-cigarette vapor contains established toxicants that as hypothesized cause acute damage to the airways and the pulmonary microvasculature that may promote the development of CLD, for which there remain few effective therapies. The study therefore propose a pilot study using a randomized crossover design in ten healthy young adults to test the acute effects of a standardized e-cigarette exposure on two sensitive, safe, non-invasive imaging measures: (1) ventilation defects on hyperpolarized helium-enhanced magnetic resonance imaging, and (2) pulmonary microvascular blood flow on gadolinium-enhanced pulmonary magnetic resonance angiography.
Primary Outcome
PMBF will be measured on gadolinium-enhanced MRI after e-cigarette and sham exposures. There were four days between the measurements of PMBF (e-cigarette) and PMBF (sham). PMBF is measured in mL(blood)/min/mL(lung volume). Lower PMBF has been observed in adults with COPD and emphysema.
Interventions
- OTHER Sham
- DRUG Gadolinium
- DEVICE E-cigarette
- DRUG Hyperpolarized 3-Helium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2017-03-01 |
| Est. Completion | 2018-07-24 |
| Phase | Early Phase 1 |
What the finished NCT02783768 record still lists
NCT02783768 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 4 interventions - of which Sham is the first listed.
NCT02783768 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02783768 about?
NCT02783768 is a clinical study titled "Ventilation and Pulmonary Endothelium Toxicities of E-cigarettes: A Randomized Crossover Pilot Study". Determination of the acute pulmonary toxicities of e-cigarettes in young adults is of major public health importance, as e-cigarette vapor contains established toxicants that as hypothesized cause acute damage to the airways and the pulmonary microvasculature that may promote the development of CLD,...
What is the current status of trial NCT02783768?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2017-03-01. Estimated completion is 2018-07-24.
What interventions are being tested in trial NCT02783768?
The interventions under investigation include: Sham (OTHER), Gadolinium (DRUG), E-cigarette (DEVICE), Hyperpolarized 3-Helium (DRUG).
Who is sponsoring clinical trial NCT02783768?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02783768's enrollment target sits among peer trials
12 1530th of 2000 higher than 401 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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