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

• Status: Completed
• Trial end date: 2018-07-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Columbia University

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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)