Ventilation and Pulmonary Endothelium Toxicities of E-cigarettes: A Randomized Crossover Pilot Study

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Pulmonary Disease, Chronic Obstructive, E-cigarettes

In brief

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.

Key facts

Study ID

NCT02783768

Run by

Columbia University

People needed

12

Starts

2017-03-01

Expected to finish

2018-07-24

Last updated by the study team

2020-10-22

Who can join

Age: 21 and older, up to 35. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• current use of e-cigarettes (>1x/month but <4 days/week)

You may not qualify if…

• any chronic medical or major psychiatric problems including current asthma
• self-reported heavy snoring/sleep apnea
• pre-bronchodilator FEV1 or FVC <80% predicted or FEV1/FVC < lower limit of normal
• MRI exclusions (pregnancy, claustrophobia, metal in body, gadolinium allergy, eGFR <60 mL/min/1.73m2)
• MRI scan with contrast within the last 12 months or planned MRI with contrast in the next 6 months
• use of any of the following in the prior 30 days: any conventional cigarettes, marijuana >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)

Where it is running

• Columbia University Irving Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.