Acute Effects of E-Cigarette Aerosol Inhalation

Early Phase 1

Completed

• Conditions: Endothelial Dysfunction; Biochemical Markers
• Interventions: Drug: Electronic Cigarette Aerosol

• Registration Number: NCT03479203
• Lead Sponsor: University of Pennsylvania

Brief 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.

Detailed Description

Here, we 1) investigate the acute effects of non-nicotinized e-cigarette aerosol inhalation in nonsmokers in terms of blood-based markers of inflammation and oxidative stress, and 2) evaluate their association with hemodynamic-metabolic MRI parameters quantifying peripheral vascular reactivity, cerebrovascular reactivity, and aortic stiffness.

Study Timeline

• Study First Submitted: 2018-02-28
• Study First Submitted QC: 2018-03-23
• Study First Posted: 2018-03-27
• Study Start: 2018-05-22
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31
• Results First Submitted: 2023-08-14
• Status Verified: 2024-04
• Results First Submitted QC: 2024-04-15
• Last Update Submitted: 2024-04-15
• Results First Posted: 2024-05-08
• Last Update Posted: 2024-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• BMI of 18.5 - 30

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy, Non-Smokers	Electronic Cigarette Aerosol	Non-nicotinized electronic cigarette aerosol (16 2-second long puffs)

Primary Outcome Measures

Name	Time	Method
Inflammatory Blood-Based Biomarkers	Participant blood draws occurred at two time points: 1) pre-vaping, 2) 120 minutes post-vaping. Inflammation index is calculated from the fold change in biomarker values over pre-vaping values	Post-vaping inflammation monitored by changes in an integrated cluster of blood-based biomarkers from serum/plasma of non-smoking healthy participants quantified at 0 and 120 min post-inhalation. The cluster consisted of: CRP, sICAM-1 in serum and HMGB1, ASC in plasma assayed using ELISA and quantified using absorbance-concentration curves generated by the manufacturers' standards; nitric oxide metabolites (nitrate + nitrite, NOx) in serum assayed with a nitrate/nitrite kit using a colorimetric standard provided by the manufacturer; reactive oxygen species (ROS) was quantified by using immortalized human pulmonary microvascular endothelial cells plated, prepared with serum, labeled with ROS dye and imaged confocal fluorescence microscopy.; The outcome measure was expressed as fold increase over pre-vaping values.
Change in Overshoot Post-Vaping	Overshoot was calculated at two time points: 1) pre-vaping, and 2) 40 minutes post-vaping.	Degree of overcompensatory effect post-vaping in the supply of oxygen after ischemia.
Change in Washout Time Post-Vaping	Washout time calculation occurred at two time points: 1) pre-vaping, and 2) 40 minutes post-vaping	Transit time of desaturated capillary blood from tissue to the imaging location after e-cigarette vaping
Change in Upslope Post-Vaping	Upslope was calculated at two time points: 1) pre-vaping, and 2) 40 minutes post-vaping	Tissue oxygen resaturation rate after e-cigarette vaping.
Acute Change in Aortic Pulse Wave Velocity Post-vaping	PWV calculation occurred at two time points: 1) pre-vaping, 2) Fifteen minutes post-vaping.	Central arterial stiffness was assessed using aortic pulse-wave velocity (PWV), a biomarker of aortic stiffness calculated by measuring the velocity of a pulse wave between two points in the same artery. A higher aortic pulse wave velocity equates to a stiffer aorta.; In each participant, aortic PWV was quantified, pre- and post-vaping, by dividing the path length of the aortic arch determined from a oblique sagittal image, by the transit time of the pulse pressure wave. Measurements obtained pre-vaping were compared to those obtained post-vaping.
Change in Femoral Artery Flow-Mediated Dilation Post-Vaping	Flow mediated dilation calculation occurred at two time points: 1) pre-vaping, 2) 40 minutes post-vaping.	Degree of dilation (% change in cross-sectional area) of femoral artery during hyperemia (the transient increase in blood flow velocity) after e-cigarette vaping as compared to before e-cigarette vaping.
Change in Breath Hold Index Post-Vaping	Breath hold index was calculated at two time points: 1) pre-vaping, 2) five minutes post-vaping.	Rate of increase in blood flow velocity in the superior sagittal sinus from intermittent volitional apnea.

Trial Locations

Locations (1)

University of Pennsylvania Perelman School of Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States