Impact of Secondhand Exposure to E-cigarettes Aerosols on the Respiratory System

Summary

Limited studies have evaluated potential exposure to secondhand e-cigarette aerosol, an indication of impact on indoor air quality. Also limited are the studies regarding direct passive exposure of humans and most of these studies have limitations, such as the small number of participants, the different methodology and devices used, or the fact that they are laboratory studies, where exposure parameters differ significantly from the actual user's habit and device. Therefore, TackSHS Project has foreseen an intervention study of cross-over design in similar to real-life conditions that aims to assess the mediating effect of e-cigarette battery output on pulmonary outcomes and indexes to provide a better understanding of the extent to which passive exposure to aerosols produced by use of e-cigarette impacts exhaled NO and exhaled breath condensate metabolites.

Conditions

• Second Hand Tobacco Smoke

Interventions

OTHER

Secondhand exposure to e-cigarette aerosols (low)

Participants will be exposed to secondhand aerosols produced by e-cigarette use. E-cigarette with low resistance will be used by an experienced smoker (tobacco flavor liquid, 12 mg nicotine, 4 sec puffs, 20-30 seconds inter-puff interval). Duration of exposure: 30 minutes. All study subjects will participate in this arm as the study has a cross-over design.

OTHER

Secondhand exposure to e-cigarette aerosols (high)

Participants will be exposed to secondhand aerosols produced by e-cigarette use. E-cigarette with high resistance will be used by an experienced smoker (tobacco flavor liquid, 12 mg nicotine, 4 sec puffs, 20-30 seconds inter-puff interval). Duration of exposure: 30 minutes. All study subjects will participate in this arm as the study has a cross-over design.

Sponsors & Collaborators

• Hellenic Cancer Society

  collaborator OTHER

• Public Health Agency of Barcelona

  collaborator OTHER

• Institut Català d'Oncologia

  lead OTHER

Principal Investigators

• Anna Tzortzi, MD,FCCP · Hellenic Cancer Society

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

35 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-09-30

Primary Completion

2017-12-31

Completion

2019-10-31

Countries

• Greece

Study Locations