Clinical trial NCT04316234: Acute Health Effects of Passive Vape Among COPD Patients
Official title: Acute Health Effects of Passive Exposure to Particles From Electronic Cigarettes - a Randomized Controlled Double-blinded Cross-over Trial Among COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Electronic Cigarette Use
Second Hand Smoke
Lung Function
Keywords: Electronic cigarettes
Secondhand vape
Health effects
Lung function
Biomarkers
Chronic Obstructive Pulmonary Disease
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2020-03-20
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A randomised double-blinded cross-over study
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
Secondary outcomes:
measure: Change in Lung Function (FEV1 & FVC)
timeFrame: At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours)
measure: Change in Fractional exhaled nitric oxide (FENO)
timeFrame: At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours)
measure: Change in Blood samples
timeFrame: At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours)
measure: Change in nasal volume (using Acoustic rhinometry)
timeFrame: At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours)
measure: Change in Symptom questionnaire
timeFrame: Every 30 min during 4 hours of exposure.
measure: Change in biomarkers in Saliva Sample
timeFrame: At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours)
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University
state: Central Region Denmark
Study officials:
affiliation: University of Aarhus
name: Karin R Laursen, MSc
role: PRINCIPAL_INVESTIGATOR
References: