CompletedNot Applicable

Effect of E-Liquid Flavor on Respiratory Symptoms in People Using Electronic Nicotine Delivery Systems

United States163 participantsStarted 2022-06-12

Plain-language summary

This is a randomized, parallel-group open-label trial to evaluate respiratory symptoms in ENDS users switching from banned flavors to a non-banned flavor (tobacco) or 'tobacco free' nicotine pouches.

Who can participate

Age range

21 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * ENDS users as determined by: (a) using banned flavored ENDS with nicotine such as fruit, candy, dessert flavors, and/or any product that indicates such flavors (b) using ENDS daily, regularly for the past 6 months (self-reported). * No smoking tobacco or using smokeless tobacco for the past 6 months. * Subjects should be free of acute respiratory illness within the proceeding 30 days prior to recruitment (self-reported). * Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure. * After receiving information regarding the NYS flavor ban individuals must not want to quit vaping or stop using their flavored product for the next 90 days. Exclusion Criteria: * Individuals with health conditions and therapies that may affect immune responses and levels of inflammatory markers, including allergic rhinitis, aspirin/NSAID therapy, asthma, immunodeficiency (HIV or other), Guillain-Barre Syndrome, COPD, or fever/respiratory illness within 30 days prior to entry into study (self-reported). * Pregnant or nursing female participants (self-reported on telephone screener, pregnancy test on Visit#1) * Unable to communicate in English. * Unable or unwilling to follow protocol requirements. * Self-report having active, untreated medical/psychiatric conditions. * History of serious side effects from nicoti…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This study looked at how different e-liquid flavors affect inflammation and oxidative stress in the lungs — if I currently vape, should I be concerned that the specific flavors I use might be causing more respiratory harm than others?
2Since the trial is already completed, is there any published data from this study my doctor could review to help us understand what the findings showed about vaping-related lung inflammation?
3The study measured biomarkers of inflammation using blood or tissue tests (ELISA) — does my doctor think I should get any similar testing done to check whether my current vaping habit is affecting my respiratory health?
4Given that this trial focused specifically on respiratory tract inflammation in people who use e-cigarettes, would my doctor recommend I consider quitting or switching habits now rather than waiting for more research, especially if I already have any respiratory symptoms?
5Are there standard-of-care options or smoking cessation programs my doctor would recommend I explore first, given what's already known about vaping and lung inflammation, before considering participation in any future research studies?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Risk Biomarkers of Inflammation and Oxidative Stress as Measured by ELISA

Timeframe: Up to around 90 days.

Respiratory Tract Inflammation Activity

Timeframe: Visit #1-beginning of the trial, Visit#2-after one week ± 2 days, Visit#3-after 1 month ±7 days, and Visit#4-after 3 months ± 14 days

Trial details

NCT IDNCT05423340

SponsorRoswell Park Cancer Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-03

Results submitted2026-01-12

View on ClinicalTrials.gov More Electronic Cigarette Use trials

Who can participate

Age range

21 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.