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Completed

NCT Number: NCT04316234

Acute Health Effects of Passive Vape 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.

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Key information

Conditions

Electronic Cigarette Use Behavior Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Lung Function Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Second Hand Smoke Smoking Vaping

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University

Aarhus, Central Region Denmark, 8000, Denmark

About this 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Passive vape

Other

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 .

Primary outcomes

  1. Change in Particles in Exhaled Air (Surfactant Protein A & Albumin)

    Time frame: At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours)

    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.

Secondary outcomes

  1. Change in Lung Function (FEV1 & FVC)

    Time frame: At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours)

    Spirometry

  2. Change in Fractional exhaled nitric oxide (FENO)

    Time frame: At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours)

    NIOX system; Aerocrine AB, Sweden

  3. Change in Blood samples

    Time frame: At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours)

    IL-8, Nightingale analyses for biomarkers

  4. Change in nasal volume (using Acoustic rhinometry)

    Time frame: At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours)

    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.

  5. Change in Symptom questionnaire

    Time frame: Every 30 min during 4 hours of exposure.

    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.

  6. Change in biomarkers in Saliva Sample

    Time frame: At baseline (0 hour), after exposure (4 hours), and the day after exposure (24 hours)

    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.)

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital

Registry information

Official study title

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

Acronym: PASVAP

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 20, 2020
Registry last updated
Mar 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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