Exposure to E-cigarette Aerosols in Real-life Conditions

NCT04140630 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2019-10-28

No results posted yet for this study

Summary

Objective: To investigate in real-life conditions passive exposure to aerosols from the use of e-cigarettes among people who cohabit with e-cigarette users. A secondary objective is to investigate passive exposure to emissions from the use of conventional cigarettes and heated tobacco products among people who cohabit with users of these tobacco products.

Study design: This is an observational study conducted in four types of households: a) Homes with one exclusive e-cigarette user and at least one non-user (non-smoker), and no other users of any type of tobacco products. In these homes, one non-user and one user will be included in the study as participants ("type A" homes); b) Homes with one exclusive heated tobacco product (HTP) user and at least one non-user (non-smoker), and no other users of any type of tobacco products or e-cigarettes. In these homes, one non-user and one user will be included in the study as participants ("type B" homes); c) Homes with one exclusive manufactured cigarette smoker (not roll-your-own) and at least one non-smoker, and no other users of any type of tobacco products or e-cigarettes. In these homes, one non-smoker and one smoker will be included in the study as participants ("type C" homes); and d) Homes where no one uses e-cigarettes or consumes any other type of tobacco products (smoke-free homes). In these homes, one adult volunteer will be included in the study as a participant ("type D" homes).

The study will be conducted in 4 countries: Greece (Athens), Italy (Milan), Spain (Barcelona) and the UK (Edinburgh). Overall, the sample in each participating country will consist of the types of participants mentioned above, with a total of 250 participants.

Measurements: Passive exposure to e-cigarette aerosols will be assessed by measuring particulate matter (PM2.5) and airborne nicotine in the main room of homes during 7 days. Participants' saliva samples will be collected for nicotine and cotinine assessment. In addition, participants will be asked to fill in a personal diary about the use of e-cigarettes, second-hand exposure to e-cigarette aerosols (SHA) and exposure to second-hand smoke (SHS) produced by the use of conventional cigarettes.

Conditions

  • Passive Exposure to Electronic Cigarette Aerosols

Interventions

OTHER

No intervention

No intervention; 1 week observational study

Sponsors & Collaborators

  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    collaborator OTHER
  • University of Stirling

    collaborator OTHER
  • Hellenic Cancer Society

    collaborator OTHER
  • Mario Negri Institute for Pharmacological Research

    collaborator OTHER
  • Institut Català d'Oncologia

    lead OTHER

Principal Investigators

  • Esteve Fernández, Dr · Catalan Institute of Oncology (ICO) // Bellvitge Biomedical Research Institute (IDIBELL)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2019-10-31
Completion
2019-10-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04140630 on ClinicalTrials.gov