Cross-Sectional Survey on the Use of Tobacco Products - Italy

Cross Sectional Survey on the Use of Tobacco Products in the General Population and in Users of IQOS in Italy (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 Italy.

Study Overview

• Status: Terminated
• Conditions: Tobacco Use
• Intervention / Treatment: Other: Survey on Use of Tobacco Products in the General Population; Other: Survey on Use of Tobacco Products in IQOS Users

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.

• Study Type: Observational
• Enrollment (Actual): 6107

Contacts and Locations

• Study Contact: Name: Luis Prieto, PhD; Phone Number: +41 58 242 11 11; Email: luis.prieto@pmi.com

Study Locations

• Switzerland
  • Lausanne, Switzerland, 2000
    • Philip Morris Products S.A.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

The study population will be limited to residents of Italy.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
General Population; Survey on use of tobacco products in the general population of adults living in Italy.	Other: Survey on Use of Tobacco Products in the General Population; Face-to-face survey to estimate the prevalence of current tobacco use status in the general population of Italy.
IQOS Users; Survey on use of tobacco products in adult current IQOS Users (at the time of survey) living in Italy who are registered in the Italy IQOS User Database and agreed to be contacted for research purposes at the time of registration.	Other: Survey on Use of Tobacco Products in IQOS Users; Online survey to describe patterns of use in IQOS users residing in Italy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of current tobacco use	Prevalence of current tobacco use status in the study population.	Study duration (3 years).
Past tobacco use status	Past tobacco use status (cigarette, IQOS and other innovative products) in the study population.	Study duration (3 years).
Self-reported health status	Association between self-reported health status and use of tobacco products in the study population.	Study duration (3 years).
Perceived risk	Association between patterns of use with perceived risk.	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 relevant domains where IQOS may have potential benefits).	Study duration (3 years).

Collaborators and Investigators

• Sponsor: Philip Morris Products S.A.
• Investigators: Study Chair: Pierpaolo Magnani, Philip Morris Products S.A.

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2018
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: May 4, 2018
• First Submitted That Met QC Criteria: May 15, 2018
• First Posted (Actual): May 16, 2018

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Tobacco Use; IQOS
• Other Study ID Numbers: P1-PMX-02-IT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No