CompletedNot Applicable

Acute Health Effects of Passive Vape Among COPD Patients

Denmark16 participantsStarted 2017-03-01

Plain-language summary

The use of e-cigarettes is often permitted in otherwise smoke-free areas causing passive vape exposure for present individuals. Little is known about the potential adverse health effects of passive vape, and people with respiratory diseases may be more susceptible. The aim of the present study was to investigate local and systemic effects of short-term passive exposure to vape from e-cigarettes among patients with mild or moderate chronic obstructive pulmonary disease COPD in a randomized controlled double-blinded cross-over study.

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: * Never smoker or ex-smokers ≥ 6 months * Aged 18+ * A known diagnosis of COPD (FEV1/FVC \< lower limit of normal, app. 70%) * MRC ≥ 2 or CAT score ≥ 10 Exclusion Criteria: * Exposure to smoking more than 30 min./day * Treatment with inhaled or oral corticosteroids * Known hypersensitivity to constituents in e-cigarettes * Any other disease that could influence the study parameters * Conditions that prevent safe access to the climate chambers (such as claustrophobia) * Perennial rhinitis * Deformed nasal airways * Not being able to change from long-acting medication to short-acting medication

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

Change in Particles in Exhaled Air (Surfactant Protein A & Albumin)

Timeframe: At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours)

Trial details

NCT IDNCT04316234

SponsorUniversity of Aarhus

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-11-30

View on ClinicalTrials.gov More Electronic Cigarette Use trials