Tobacco UseNCT03527017
Cross-Sectional Survey on the Use of Tobacco Products - Germany
An observational study of Tobacco Use, run by Philip Morris Products S.A. at 1 site in Switzerland.
Trial summary
The main purpose of the research study is to estimate the prevalence of tobacco product use and describe the tobacco use patterns in adults in Germany. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use
- What is being tested?
- Survey on Use of Tobacco Products in the General Population and Survey on Use of Tobacco Products in IQOS Users
- How many people
- 6,284 participants
- Where
- 1 siteSwitzerland
- Study dates
- 12 Mar 2018to 24 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will be limited to residents of Germany.
Who may be able to join
- Has used more than 100 HEETS tobacco sticks in his or her lifetime.
- Is currently using IQOS.
- Has access to the internet.
- Is not currently employed by Philip Morris International or any of its affiliates
Who cannot join
- Not meeting the inclusion criteria
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Philip Morris Products S.A.
Lausanne, Canton of Vaud, 1007
About this study
Official title: Cross-Sectional Survey on the Use of Tobacco Products in the General Population and in Users of IQOS in Germany (2018-2020)
The main purpose of the research study is to estimate the prevalence of tobacco product use and describe the tobacco use patterns in adults in Germany.
Read the detailed description
The aim of the survey is to describe the current and past patterns of use of tobacco products in the general adult population of Germany and in adult IQOS users registered in the IQOS user database of Philip Morris GmbH (Germany IQOS User Database), and explore their association with key independent variables. More specifically, the objectives are:
- Estimate the prevalence of current tobacco use status in the study population.
- Describe the past tobacco use status (cigarette, IQOS and other innovative products, including e-cigarettes) in the study population (i.e. never-use, initiation, product use transition, cessation, re-initiation, and relapse).
- Explore the association between self-reported health status and use of tobacco products in the study population.
- Explore the association between patterns of use (including misuse) with motivation to use, perceived quality attributes of IQOS (e.g. risk and self-reported changes since switching to the product, in a number of relevant domains where IQOS may have potential benefits), and consumer's satisfaction in the population of IQOS users in Germany registered in the Germany IQOS User Database.
- Conditions
- Tobacco Use
- Being tested
- Survey on Use of Tobacco Products in the General Population, Survey on Use of Tobacco Products in IQOS Users
- Keywords
- Tobacco Use, IQOS
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey on Use of Tobacco Products in the General PopulationOther
Face-to-face survey to estimate the prevalence of current tobacco use status in the general population of Germany.
Survey on Use of Tobacco Products in IQOS UsersOther
Online survey to describe patterns of use in adult IQOS users residing in Germany.
| Study group | Role | What they receive |
|---|---|---|
| General Population | Adults living in Germany. Receives: Other: Survey on Use of Tobacco Products in the General Population | |
| IQOS Users | Adult current IQOS users (at the time of survey) living in Germany who are registered in the Germany IQOS User Database and agreed to be contacted for research purposes at the time of registration. Receives: Other: Survey on Use of Tobacco Products in IQOS Users |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of current tobacco use
Prevalence of current tobacco use status in the study population.
Measured: Study duration (3 years).
Past tobacco use status
Past tobacco use status (cigarette, IQOS and other innovative products) in the study population.
Measured: Study duration (3 years).
Self-reported health status
Association between self-reported health status and use of tobacco products in the study population.
Measured: Study duration (3 years).
Perceived risk
Association between patterns of use with perceived risk.
Measured: Study duration (3 years).
IQOS use experience
Describe the IQOS user experience, including motivation to use, mis-use, satisfaction, and self-reported changes since switching to the product (in a number of domains where IQOS may have potential benefits).
Measured: Study duration (3 years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start12 Mar 2018
- Primary completion24 Feb 2020
- Study completion24 Feb 2020
Why it stopped: The study was terminated prematurely after 2 years because during to the COVID-19 pandemic, the face-to-face mode of administration of the interviews in the General Adult Population Sample was not feasible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 6,284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philip Morris Products S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pierpaolo Magnani, Study chair, Philip Morris Products S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527017
- Sponsor's protocol ID
- P1-PMX-03-DE
- Status last verified
- Feb 2024
- First submitted
- 4 May 2018
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-Sectional Survey on the Use of Tobacco Products in the General Population and in Users of IQOS in Germany (2018-2020)
- ClinicalTrials.gov ID
- NCT03527017
- Acronym / sponsor ID
- P1-PMX-03-DE
- Conditions
- Tobacco Use
- Keywords
- Tobacco Use, IQOS
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was terminated prematurely after 2 years because during to the COVID-19 pandemic, the face-to-face mode of administration of the interviews in the General Adult Population Sample was not feasible.
- Enrolment
- 6,284 participants (actual)
- Lead sponsor
- Philip Morris Products S.A.Industry (pharma, biotech, devices)
- Study start
- 12 Mar 2018 (actual)
- Primary completion
- 24 Feb 2020 (actual)
- Study completion
- 24 Feb 2020 (actual)
- First posted
- 16 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of the research study is to estimate the prevalence of tobacco product use and describe the tobacco use patterns in adults in Germany.
Detailed description
The aim of the survey is to describe the current and past patterns of use of tobacco products in the general adult population of Germany and in adult IQOS users registered in the IQOS user database of Philip Morris GmbH (Germany IQOS User Database), and explore their association with key independent variables. More specifically, the objectives are:
- Estimate the prevalence of current tobacco use status in the study population.
- Describe the past tobacco use status (cigarette, IQOS and other innovative products, including e-cigarettes) in the study population (i.e. never-use, initiation, product use transition, cessation, re-initiation, and relapse).
- Explore the association between self-reported health status and use of tobacco products in the study population.
- Explore the association between patterns of use (including misuse) with motivation to use, perceived quality attributes of IQOS (e.g. risk and self-reported changes since switching to the product, in a number of relevant domains where IQOS may have potential benefits), and consumer's satisfaction in the population of IQOS users in Germany registered in the Germany IQOS User Database.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Population | – | Other: Survey on Use of Tobacco Products in the General PopulationAdults living in Germany. |
| IQOS Users | – | Other: Survey on Use of Tobacco Products in IQOS UsersAdult current IQOS users (at the time of survey) living in Germany who are registered in the Germany IQOS User Database and agreed to be contacted for research purposes at the time of registration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be limited to residents of Germany.
Key inclusion criteria (4 listed)
- Has used more than 100 HEETS tobacco sticks in his or her lifetime.
- Is currently using IQOS.
- Has access to the internet.
- Is not currently employed by Philip Morris International or any of its affiliates
Key exclusion criteria (1 listed)
- Not meeting the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey on Use of Tobacco Products in the General PopulationFace-to-face survey to estimate the prevalence of current tobacco use status in the general population of Germany. | Other | General Population |
| Survey on Use of Tobacco Products in IQOS UsersOnline survey to describe patterns of use in adult IQOS users residing in Germany. | Other | IQOS Users |
Primary outcome
Prevalence of current tobacco use
Time frame: Study duration (3 years).
Prevalence of current tobacco use status in the study population.
Past tobacco use status
Time frame: Study duration (3 years).
Past tobacco use status (cigarette, IQOS and other innovative products) in the study population.
Self-reported health status
Time frame: Study duration (3 years).
Association between self-reported health status and use of tobacco products in the study population.
Perceived risk
Time frame: Study duration (3 years).
Association between patterns of use with perceived risk.
IQOS use experience
Time frame: Study duration (3 years).
Describe the IQOS user experience, including motivation to use, mis-use, satisfaction, and self-reported changes since switching to the product (in a number of domains where IQOS may have potential benefits).
Results and safety
The study was stopped early (reason given: The study was terminated prematurely after 2 years because during to the COVID-19 pandemic, the face-to-face mode of administration of the interviews in the General Adult Population Sample was not feasible.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierpaolo Magnani study chair
Philip Morris Products S.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tobacco Use, run by Philip Morris Products S.A. at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was terminated prematurely after 2 years because during to the COVID-19 pandemic, the face-to-face mode of administration of the interviews in the General Adult Population Sample was not feasible.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of current tobacco use (time frame: Study duration (3 years).). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.