Acute Health Effects of Passive Vape Among COPD Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2017-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effects of Heated Tobacco Products Use on Lung Function and Volatile Organic Compounds in Exhaled Air

NCT05260827

Lung Inflammation

COMPLETED NA

Effect of Electronic Cigarette Use on Cough Reflex Sensitivity

NCT02203162

Cough

COMPLETED PHASE4

Health Effects of Diesel Exhaust in Asthmatic Patients: A Real-world Study in a London Street

NCT00127062

Asthma

COMPLETED NA

Epigenetic Effects of Diesel Exhaust and Ozone Exposure

NCT01492517

Exposure to Pollution Inhalation of Ozone

COMPLETED NA

Pulmonary and Systemic Effects of Exposure to Wood Smoke

NCT03302117

Pulmonary Inflammation Cytotoxicity

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Introduction: 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.

Aim: 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).

Design: In a randomised double-blinded cross-over study non-smoking COPD patients were exposed for four hours at two different exposure conditions separated by 14 days; A) clean filtered air and B) passive vaping under controlled environmental conditions.

Measurements: TSI P-TRAK Ultrafine Particle Counter was used for particle counts. Health effects, including lung function (FEV1/FVC) and fraction of exhaled nitric oxide (FeNO) were evaluated in relation to local and systemic effects prior to, right after and 24 h. after exposure.

Analysis: Mixed methods approach taking both time and exposure into account.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Electronic Cigarette Use Second Hand Smoke Lung Function

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

A randomised double-blinded cross-over study

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Vaping was done in another chamber and thereby led into the exposure chamber, so it could not be observed. On days with clean air, vapers were chewing nicotine gum instead of vaping.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A. Clean Air

Clean air - no vaping was done.

Group Type NO_INTERVENTION

No interventions assigned to this group

B. Passive vaping

E-cigarette users were present in an adjacent chamber during both exposures, but only in situation B they were vaping and the vape-polluted air was passed on to the exposure chamber.

Group Type EXPERIMENTAL

Passive vape

Intervention Type OTHER

On days with passive vape, 2-3 vapers in an adjacent chamber were vaping by turn, and vape was passed on to the exposure chamber continuously .

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Passive vape

On days with passive vape, 2-3 vapers in an adjacent chamber were vaping by turn, and vape was passed on to the exposure chamber continuously .

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes