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

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

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.

Study Overview

• Status: Completed
• Conditions: Electronic Cigarette Use; Lung Function; Second Hand Smoke
• Intervention / Treatment: Other: Passive vape

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Central Region Denmark
    • Aarhus, Central Region Denmark, Denmark, 8000
      • Aarhus University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: A. Clean Air; Clean air - no vaping was done.
Experimental: 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.	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 .

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Aarhus University Hospital
• Investigators: Principal Investigator: Karin R Laursen, MSc, University of Aarhus

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): November 30, 2017
• Study Completion (Actual): November 30, 2017

Study Registration Dates

• First Submitted: February 5, 2020
• First Submitted That Met QC Criteria: March 18, 2020
• First Posted (Actual): March 20, 2020

Study Record Updates

• Last Update Posted (Actual): March 20, 2020
• Last Update Submitted That Met QC Criteria: March 18, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Biomarkers; Lung function; Chronic Obstructive Pulmonary Disease; Electronic cigarettes; Secondhand vape; Health effects
• Other Study ID Numbers: 1711000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No