UnknownNot Applicable

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

Greece40 participantsStarted 2016-09

Plain-language 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.

Who can participate

Age range18 Years – 35 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: For non-smokers: * Age 18-35 * Non-smokers (exhaled CO measurement before each session), or * Ex-smokers (\> 1 year) * Healthy as by non-significant medical history, normal physical examination and flow volume loop within predicted normal limits (ATS/ERS Task Force 2005) * Normal BMI\< 30 For e-cigarette users * Age 18-35 * Normal BMI\< 30 * Experienced e-cig users:\>2 months use * Healthy as by non-significant medical history, normal physical examination and flow volume loop within predicted normal limits (ATS/ERS Task Force 2005) Exclusion Criteria: For non-smokers * Smokers of all kinds and devices, ex-smokers (\< 1 year) * Age \<18, \>35 * BMI\>30 * Pregnancy, lactation * Ongoing or recent illness (\<4 weeks prior to study), recent infection (\<4 weeks) * Acute or chronic condition or disease (diabetes, asthma, COPD, congenital heart disease, arrhythmia, hypertension…) * Medication of any kind (\<2 weeks prior to study) For e-cigarette users * Non-smokers * Age \<18, \>35 * BMI\>30 * Pregnancy, lactation * Ongoing or recent illness (\<4 weeks prior to study), recent infection (\<4 weeks). * Acute or chronic condition or disease (diabetes, asthma, COPD, congenital heart disease, arrhythmia, hypertension…) * Medication of any kind (\<2 weeks prior to study)

What they're measuring

Mechanical functions of respiratory system

Timeframe: The measurements (IOS, FeNO, EBC) will be performed in each trial arm immediately after the exposure; the 30 minutes time frame applies for the collective measurements and it is the time needed to perform all 3 tests according to the ATS/ERS guidelines.

Fraction of Exhaled Nitric Oxide (FeNO)

Trial details

NCT IDNCT03102684

SponsorInstitut Català d'Oncologia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-12

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