Clinical trial NCT03527004: Cross-Sectional Survey on the Use of Tobacco Products - Italy
Official title: Cross Sectional Survey on the Use of Tobacco Products in the General Population and in Users of IQOS in Italy (2018-2020)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Tobacco Use
Keywords: Tobacco Use
IQOS
Lead sponsor: Philip Morris Products S.A.
Sponsor class: INDUSTRY
First posted: 2018-05-16
Enrollment: 6107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will be limited to residents of Italy.

Brief 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 Italy.

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 Italy and in adult IQOS users registered in the IQOS user database of Philip Morris Italia S.r.l. (Italy IQOS User Database), and explore their association with key independent variables. More specifically, the objectives are:

1. Estimate the prevalence of current tobacco use status in the study population.
2. 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).
3. Explore the association between self-reported health status and use of tobacco products in the study population.
4. 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 Italy registered in the Italy IQOS User Database.

Eligibility criteria: Inclusion Criteria (all participants, including IQOS users):

* Legally permitted to buy tobacco products in Italy (≥18 years of age).
* Currently residing in Italy.
* Able to read, write and understand Italian.
* Consent to participate in the survey

Inclusion Criteria (IQOS users only):

* 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

Exclusion Criteria:

* Not meeting the inclusion criteria.

Primary outcomes:
measure: Prevalence of current tobacco use
timeFrame: Study duration (3 years).
measure: Past tobacco use status
timeFrame: Study duration (3 years).
measure: Self-reported health status
timeFrame: Study duration (3 years).
measure: Perceived risk
timeFrame: Study duration (3 years).
measure: IQOS use experience
timeFrame: Study duration (3 years).
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Philip Morris Products S.A.
Study officials:
affiliation: Philip Morris Products S.A.
name: Pierpaolo Magnani
role: STUDY_CHAIR
References: