Exposure to E-cigarette Aerosols in Real-life Conditions
Exposure to Second-hand Aerosols Emitted by Use of Electronic Cigarettes in Real-life Conditions
1 other identifier
observational
250
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2019
CompletedFirst Submitted
Initial submission to the registry
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedFirst Posted
Study publicly available on registry
October 28, 2019
CompletedOctober 28, 2019
October 1, 2019
7 months
October 1, 2019
October 24, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Airborne nicotine concentration (mg/m3)
Median airborne nicotine concentration (1h measurements with active sampling and 7-day continuous of passive sampling) in the home environment
7 days
Secondary Outcomes (3)
Particulate matter concentration (PM2.5; in mg/m3)
7 days
Nicotine, cotinine, TSNAs and propylene glycole concentrations in saliva samples (in ng/ml)
1st day and the 7th day (pre-; post)
Metals, nicotine, cotinine and TSNAs concentrations in urine samples (in ng/ml)
One measurement; day 7 of the observational study
Study Arms (4)
E-cigarette users and bystanders
Households with one e-cigarette user (adult (18 years old and above); e-cigarette exclusive user for at least 1 month; daily use of e-cigarettes inside home; cohabiting with at least one non-tobacco product nor e-cigarette user; other household members should not be users of any tobacco products or e-cigarettes) and one bystander cohabiting with the user
Conventional cigarette smokers and bystanders
Households with one smoker (adult (18 years old and above; manufactured cigarette exclusive smoker for at least 6 months; daily smoking inside home; cohabiting with at least one non-tobacco product nor e-cigarette user; other household members should not be users of tobacco products or e-cigarettes) and one bystander cohabiting with the smoker
Heated tobacco product users and bystanders
Households with one user of the heated tobacco product, HTP (adult (18 years old and above; • HTP exclusive user for at least 1 month; daily use of HTP inside home; cohabiting with at least one non-tobacco product nor e-cigarette user; other household members should not be users of tobacco products or e-cigarettes) and one bystander cohabiting with the user
Non-smokers and non-users (control)
Smoke free households (participants should be adult (18 years old and above), non e-cigarette user (never or former e-cigarette user \>1 month), non-user of any kind of tobacco product (never or former user \>1 month), and other household members should not be users of tobacco products or e-cigarettes
Interventions
No intervention; 1 week observational study
Eligibility Criteria
Overall, the sample in each participating country will consist of these types of participants: Type A 20 e-cigarette users 20 non-users cohabiting with e-cigarette users Type B\* 5 heated tobacco product users 5 non-users cohabiting with heated tobacco product users Type C 5 conventional cigarette smokers 5 non-smokers cohabiting with conventional cigarette smokers Type D 5 non-smokers/non-users living in smoke/e-cigarette free homes
You may qualify if:
- Non-e-cigarette and non-tobacco-product users
- Adult (18 years old and above)
- Non e-cigarette user (never or former e-cigarette user \>1 month)
- Non-user of any kind of tobacco product (never or former user \>1 month)
- \[Only for type D homes\]: other household members should not be users of tobacco products or e-cigarettes
- E-cigarette users
- Adult (18 years old and above)
- E-cigarette exclusive user for at least 1 month
- Daily use of e-cigarettes inside home
- Cohabiting with at least one non-tobacco product nor e-cigarette user
- Other household members should not be users of any tobacco products or e-cigarettes
- Heated tobacco product users
- Adult (18 years old and above)
- HTP exclusive user for at least 1 month
- Daily use of HTP inside home
- +8 more criteria
You may not qualify if:
- For all participants:
- To be daily exposed to SHS from tobacco products or to SHA from e-cigarettes in places other than home.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut Català d'Oncologialead
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milanocollaborator
- University of Stirlingcollaborator
- Hellenic Cancer Societycollaborator
- Mario Negri Institute for Pharmacological Researchcollaborator
Study Sites (1)
Catalan Institute of Oncology
Barcelona, 08908, Spain
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Esteve Fernández, Dr
Catalan Institute of Oncology (ICO) // Bellvitge Biomedical Research Institute (IDIBELL)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2019
First Posted
October 28, 2019
Study Start
March 1, 2019
Primary Completion
October 1, 2019
Study Completion
October 1, 2019
Last Updated
October 28, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share