Passive Exposure to Electronic Cigarette Aerosols Clinical Trial
Official title:
Exposure to Second-hand Aerosols Emitted by Use of Electronic Cigarettes in Real-life Conditions
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.
Aims: The main objective of this study is 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:
1. 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).
2. 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).
3. 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).
4. 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).
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.
Fieldwork
Once in the participants' home:
1. After checking the inclusion and exclusion criteria, the participants will be
re-informed (information was provided when contacting for the first time the
participants) about the study (information sheet for participants) and will be asked to
provide their informed written consent. They will be also informed about a reward for
their participation after finishing the study (gift card to be used in a local cultural
store with value of 15€).
2. Measurement of nicotine using active sampling will be initiated, lasting 30 min and
record of smoking/use pattern if applicable using the home dossier.
3. The researcher will install the monitor with a filter for nicotine sampling that will be
left at homes of the participants during the week of the study.
4. The researcher will administer to the participant the questionnaire about usual exposure
to SHS and SHA (for all participants) and about consumption practices and habits (for
users).
5. The participants will be instructed about the completion of the diary card that will be
used to collect daily information about exposure to SHS and SHA (for all participants)
and about patterns of smoking, e-cigarette or HTP use.
6. The first saliva sample will be collected under the supervision of the researcher.
7. AirVisual, an optical PM2.5 monitoring device, will be installed in the main room of the
home. The participants will be instructed about its functioning and contact details for
any questions will be provided in participant information leaflet.
8. The container for urine sample to be collected at the second visit after one week of the
study with instructions on the procedures will be provided to the participants.
9. The participants will be informed that:
- the researchers will be available for any queries during the study period and a
contact phone number will be provided;
- reminders to fill in the diary card will be sent via emails (SMS or the system
chosen by the participant) every day; and
- the researchers will make a follow-up telephone call during the study period
10. The researcher should inform about the day when the second visit should be done (after 7
days of the study) and confirm the time with the participants During the consequent 7
days
During 7 days of the study
The researcher will:
- call the participant to check the progress and resolve any queries, at the day 3 or 4 of
the study.
- send a text message (SMS or other system) daily to remind to fill in the diary card
- send a text message in the morning of the day of the second visit to remind about urine
sample collection
The participants will:
- fill in the diary card to record any exposure to SHA and/or SHS at home and other settings
(for all participants) and e-cigarette, HTP use or smoking pattern (for e-cigarette, HTP
users and smokers).
Second visit (7 days after first visit)
In the participants' homes, the researchers will:
- measure airborne nicotine with active sampling for 30 minutes (2nd measurement)
- review the diary cards with the participant(s) and collect them
- collect the AirVisual device and passive nicotine sampler
- collect a second saliva sample
- ask to the participant(s) for sample of e-liquid used (for e-cigarette users)
- collect the urine sample prepared by the participants (if applies)
- give the gift card to participants and ask them to sign the receipt form
- acknowledge the participation and remind that the feedback with the results of the study
will be sent to them in approximately 6 months.
Data Management: All data from questionnaires, environmental measurements and saliva analysis
will be managed by researchers from Tobacco Control Unit (UCT) of the Catalan Institute of
Oncology.
Data will be collected in paper and will be digitalised in a protected database. All the
samples (environmental, biological, and e-cigarette liquid) will have a unique code to be
linked with the already anonymized data from the questionnaires, and this data will be stored
in the same database. Only a selected number of pre-designated members of the research team
(who will sign a confidentiality document) will have access to the database and the freezer.
All data will be stored into a single database.
Selected personal data, including the names of respondents, will be collected separately to
enable quality assurance procedures and to allow participants' willing to withdraw from
participation in the study to have their records deleted from the database. This information
will remain dissociated from the specific information generated in the experiments.
During the quality assurance procedures, Dr Esteve Fernández will obtain an anonymised copy
of the database. The database will be held securely on a password protected file server at
ICO. Dr Fernández will designate a limited number of researchers from UCT team or the
consortium to access this database.
Access to personal data and withdrawal from the study: It will be made clear in the
information (provided orally and in the information sheet) that the subjects are completely
free to withdraw their records from participation in the study, regardless having had a gift
compensation for their participation.
The consent given by participants in the project can be withdrawn at any time, without any
explanation or justification. In this case, all data pertaining to the subjects will be
destroyed, both in paper and digital supports.
At the end of the study, participants will receive the results from the environmental and
biological measurements conducted as well as the overall results obtained for the entire
study subjects. Summary data related to the entire project will be publicly disseminated once
it has been processed and protected, without data that allow individual identification of
participants. These summary results will be accessed through the project website or through
publications related to this project.
Human cells/tissues: Biological samples (saliva and urine) will be collected after obtaining
informed consent, in which it will be specified that these samples will be used only for the
study aims, this is, the measurement of nicotine, cotinine and other metabolites of nicotine,
metals and other markers of exposure to aerosols from e-cigarettes, but not for the use of
the cells or genetic material also contained in the saliva. The remaining saliva and urine
will be stored at the certified biobank (at ICO) and can be used for future determinations of
compounds from cigarettes and e-cigarettes related with the objectives of this study.
Privacy and confidentiality: All personal information will be treated as confidential and
will be stored in agreement with the current laws. The study will be conducted in accordance
with the Good Clinical Practice Guidelines of the Declaration of Helsinki and the current
legal regulation about confidentiality of data in the European Union (Regulation EU 2016/679
of the European Parliament and of the Council).
Environmental protection and safety: This study will require some exposure from the
participants; however, this exposure will be the usual one and the participants will not be
forced to any additional exposure given the observational nature of the study conducted. They
will record the usual exposures without any intervention from the research team. Similarly,
the researchers can be also exposed to emissions from tobacco products, but the total time of
potential exposure is out of the range of potential health hazards produced by these
exposures. All the researchers have been informed and have signed a written consent about
their participation.
Incidental findings: In case that while reviewing the results from the chemical analysis of
nicotine metabolites in saliva any unexpected abnormality is observed (what is called an
"incidental finding"), the investigators will let the participant know. Depending on the type
of incidental finding, the participant will be contacted by mail or by phone. The participant
does not have an option to decline information about an incidental finding. The costs for any
care that will be needed to diagnose or treat an incidental finding would not be paid for the
research study. These costs would be the responsibility of the participant.
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