Exposure to E-cigarette Aerosols in Real-life Conditions
NCT04140630 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 250
Last updated 2019-10-28
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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