TerminatedNot Applicable

Evaluation of Acute and Subacute Effects of Nicotine Free Electronic Cigarette(NCFE) Vapors

Stopped: due to recent release reports from CDC about lung injury due to vaping, the PI and IRB decided to terminate the study

United States30 participantsStarted 2017-02-22

Plain-language summary

This aim will examine the acute and subacute exposures to electronic cigarette (EC) vapor generated from e-liquids without nicotine (NFEC) on life-time non smokers subjects by measuring changes in nasal ion transport and TGF-β levels. Nasal ion transport will be assessed by nasal potential difference (NPD). Tumor growth factor (TGF)-β levels (mRNA and protein by ELISA) will be assessed on nasal cells and lavages.

Who can participate

Age range

18 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: INCLUSION CRITERIA: * Subjects will be over 18 years of age. * Healthy life-time non-smokers Exclusion Criteria: * Presence of airflow obstruction (COPD, asthma, bronchiectasis) * Other concomitant inflammatory pulmonary disorders * Subjects with known pulmonary malignancies within 5 years * Subjects with prior thoracic surgery * Subjects with respiratory infection that required use of oral corticosteroids and/or antibiotics within the prior 3 months * Subjects with allergies to study medications * Subjects incapable of providing informed consent.

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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

changes on nasal potential difference (NPD) measurements

Timeframe: before and after 7 days of vapor

Trial details

NCT IDNCT02585791

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-11-11

View on ClinicalTrials.gov More Healthy Lifetime Non-smokers trials