Brief Summary

This study examines how electronic (e)-cigarette use impacts the body, by studying both users and non-users of e-cigarettes. Early evidence indicates that e-cig users experience adverse health effects. Results of this study may help policy-makers develop standards for different types of tobacco.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

182

participants targeted

Target at P50-P75 for all trials

Timeline

8mo left

Started Jul 2021

Longer than P75 for all trials

Geographic Reach

1 country

1 active site

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.4 years study duration

Study Progress88%

Jul 2021Dec 2026

First Submitted

Initial submission to the registry

June 29, 2021

Completed

23 days until next milestone

First Posted

Study publicly available on registry

July 22, 2021

Completed

Same day until next milestone

Study Start

First participant enrolled

July 22, 2021

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2022

Completed

4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected

Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

11 months

First QC Date

June 29, 2021

Last Update Submit

March 18, 2026

Conditions

Cigarette Smoking-Related Carcinoma

Outcome Measures

Primary Outcomes (4)

Airway inflammation as assessed by exhaled nitric oxide
Exhaled nitric oxide will be measured in parts per billion (ppb)
Procedure will last approximately 3 minutes; the procedure will occur twice during the laboratory session (separated by approximately 60 minutes)
Airway reactivity as assessed by airwave oscillometry
Airway reactivity will be measured via Tremoflo, which is a well validated measurement of airway reactivity and provides curves of Resistance (R) and Reactance (X)
Procedure will last approximately 3 minutes; the procedure will occur twice during the laboratory session (separated by approximately 60 minutes)
Respiratory functioning as assessed by a mobile Spirometry device
Spirometry will collect daily data from participants on the relationship between their forced expiratory volume and forced vital capacity (measured as FEV1/FVC).
Procedure will last approximately 3 minutes; the procedure will occur twice during the laboratory session (separated by approximately 60 minutes)
Endothelial function
Endothelial function will be assessed with the EndoPAT device (unit of measurement = LnRHI).
Procedure will last approximately 20 minutes; the procedure will occur twice during the laboratory session (separated by approximately 90 minutes)

Study Arms (1)

Prevention (survey, breathe tests, biospecimen collection)

Participants undergo computer-based spirometry testing, nitric oxide breath testing, airwave oscillometry, and an assessment of endothelial function. Participants will undergo collection of blood. Current e-cigarette users also vape their own e-cigarette device for 30 minutes.

Procedure: Biospecimen CollectionProcedure: Nitric Oxide Breath TestProcedure: OscillometryProcedure: SpirometryOther: Survey AdministrationProcedure: Endothelial function