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

Sponsor

Philip Morris Products S.A. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT03527004

Collaborator

(none)

7,469

Enrollment

Location

41.4

Anticipated Duration (Months)

180.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tobacco Use	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:

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 Italy registered in the Italy IQOS User Database.

Study Design

Study Type:

Observational

Anticipated Enrollment :

7469 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

Cross Sectional Survey on the Use of Tobacco Products in the General Population and in Users of IQOS in Italy (2018-2020)

Actual Study Start Date :

Mar 20, 2018

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Sep 1, 2021

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Philip Morris Products S.A.	Neuchâtel		Switzerland	2000

Sponsors and Collaborators

Philip Morris Products S.A.

Investigators

Study Chair: Luis Prieto, PhD, Philip Morris Products S.A.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Philip Morris Products S.A.

ClinicalTrials.gov Identifier:

NCT03527004

Other Study ID Numbers:

P1-PMX-02-IT

First Posted:

May 16, 2018

Last Update Posted:

Apr 18, 2019

Last Verified:

Apr 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Philip Morris Products S.A.

Tobacco Use

IQOS

Study Results

No Results Posted as of Apr 18, 2019