An interventional study of Passive vape in Electronic Cigarette Use, Second Hand Smoke and Lung Function, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-20.
Sponsored by University of Aarhus · Not applicable, Interventional, and Prevention
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.
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.
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Exclusion Criteria:
Clean air - no vaping was done.
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
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 .
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.
Time frame: At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours)
Change in Lung Function (FEV1 & FVC)
Spirometry
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.)
Time frame: At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours)
Plan to share: No
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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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University of Aarhus