Acute Health Effects of Passive Vape Among COPD Patients (PASVAP)

University of Aarhus

Status: Completed

Conditions: Electronic Cigarette Use; Lung Function; Second Hand Smoke

Treatments: Other: Passive vape

Study type: Interventional

Funder types: Other

Identifiers

NCT04316234

1711000

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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16 participants in 2 patient groups

A. Clean Air

No Intervention group

Description:

Clean air - no vaping was done.

B. Passive vaping

Experimental group

Description:

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.

Treatment:

Other: Passive vape