Acute Health Effects of Passive Vape Among COPD Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Acute Health Effects of Passive Exposure to Particles From Electronic Cigarettes - a Randomized Controlled Double-blinded Cross-over Trial Among COPD Patients

Conditions
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Electronic Cigarette Use, Second Hand Smoke, Lung Function

Intervention / Treatment
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* Other: Passive vape


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: A randomised double-blinded cross-over study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: A. Clean Air<br>Clean air - no vaping was done. | |
| Experimental: B. Passive vaping<br>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. | Other: Passive vape<br>* 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 .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Particles in Exhaled Air (Surfactant Protein A & Albumin) | PExA: Subjects performed repeated breath maneuvers allowing for airway closure and re-opening, and exhaled particles were optically counted and collected on a membrane using the (novel) PExA® instrument set-up. | At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Lung Function (FEV1 & FVC) | Spirometry | At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours) | 
| Change in Fractional exhaled nitric oxide (FENO) | NIOX system; Aerocrine AB, Sweden | At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours) | 
| Change in Blood samples | IL-8, Nightingale analyses for biomarkers | At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours) | 
| Change in nasal volume (using Acoustic rhinometry) | Is used to assess the nasal cross sectional area and volume. The left and right nasal cavity were studied alternatively until three reproducible measurements were obtained. The minimum cross sectional cavity area was calculated from the means of the measurements. By integration of the area-distance curve, the sum of the volume 2 to 4 (vol2-4) from the nostril was determined on both sides. | At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours) | 
| Change in Symptom questionnaire | In the exposure chamber participants were asked to fill out a symptom questionnaire every 30 min. regarding their well-being and experienced symptoms in eyes, nose and mouth. | Every 30 min during 4 hours of exposure. | 
| Change in biomarkers in Saliva Sample | An oral svap from Salivette was placed in the mouth of the participant to collect saliva by gently chewing the swab for one minute. Afterwards the saturated swab was removed to the suspended insert and closed firmly with a lid. Then the sample was transferred to a freezer and stored for -80 C until further analysis. The sample will be analyzed for biomarkers (amylase, cortisol, substance P, lysozyme and secretory IgA.) | At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electronic cigarettes, Secondhand vape, Health effects, Lung function, Biomarkers, Chronic Obstructive Pulmonary Disease