Early Phase 1 N=31 Basic Science

Acute Effects of E-Cigarette Aerosol Inhalation

Endothelial Dysfunction · Biochemical Markers

Bottom Line

View on ClinicalTrials.gov: NCT03479203 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2024

Primary outcome: Primary: Inflammatory Blood-Based Biomarkers — 5 fold change — p=0.05

Study Design & Population

Study type: Interventional
Phase: Early Phase 1
Interventions: Electronic Cigarette Aerosol (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: University of Pennsylvania
Primary completion: Aug 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Inflammatory Blood-Based Biomarkers	5	0.05
PRIMARY Acute Change in Aortic Pulse Wave Velocity Post-vaping	0.19	—
PRIMARY Change in Femoral Artery Flow-Mediated Dilation Post-Vaping	-3.20	—
PRIMARY Change in Washout Time Post-Vaping	-1.50	—
PRIMARY Change in Upslope Post-Vaping	—	—
PRIMARY Change in Overshoot Post-Vaping	10	—
PRIMARY Change in Breath Hold Index Post-Vaping	-0.02	—

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.

Eligibility Criteria

Inclusion Criteria

BMI of 18.5 - 30

Exclusion Criteria

Cancer
HIV
Mental illness
Overt cardio- or neurovascular disease (prior heart attack, stroke, transient ischemic attacks)
Serious arrhythmias
Bronchospastic disease
Upper respiratory tract infection within the past six weeks
Chronic medication or antibiotics
Claustrophobia / contraindications for MRI

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03479203). 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.