Early Phase 1
N=11
Ventilation and Pulmonary Endothelium Toxicities of E-cigarettes: A Randomized Crossover Pilot Study
Pulmonary Disease, Chronic Obstructive · E-cigarettes
Bottom Line
View on ClinicalTrials.gov: NCT02783768 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Pulmonary Microvascular Blood Flow (PMBF), Measured on Gadolinium-enhanced MRI, Between E-cigarette Exposed and Unexposed Conditions — 74.4; 63.1 mL(blood)/min/mL(lung) — p=0.012
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- E-cigarette (Device); Sham (Other); Hyperpolarized 3-Helium (Drug); Gadolinium (Drug)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pulmonary Microvascular Blood Flow (PMBF), Measured on Gadolinium-enhanced MRI, Between E-cigarette Exposed and Unexposed Conditions |
74.4; 63.1 | 0.012 sig |
| PRIMARY Ventilation Defect Percentage (VDP), Measured on Hyperpolarized 3-helium Enhanced MRI |
5.5; 6.6 | — |
| SECONDARY Regional PMBF, Measured on Gadolinium-enhanced MRI |
— | — |
| SECONDARY Regional VDP, Measured on Hyperpolarized 3-helium Enhanced MRI |
3.6; 5.8 | — |
| SECONDARY Lung Function, Measured on Spirometry |
4.22; 4.08 | — |
| SECONDARY Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) |
33.65; 32.73 | — |
| SECONDARY Cardiac Output, Measured on Cardiac MRI |
6197; 6093 | — |
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.
Eligibility Criteria
Inclusion Criteria
- current use of e-cigarettes (>1x/month but 10 days, any illicit drugs, any medication or inhalers (excluding hormonal contraceptives)
- binge drinking (≥5 alcoholic beverages over 2 hours) over the prior two weeks
- adverse symptomatic response to the study e-cigarette exposure (e.g., palpitations, shortness of breath, chest pain, headache, dizziness)
Data sourced from ClinicalTrials.gov (NCT02783768). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.