NCT03527004

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,107

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 16, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

1.9 years

First QC Date

May 4, 2018

Last Update Submit

February 26, 2024

Conditions

Keywords

Tobacco UseIQOS

Outcome Measures

Primary Outcomes (5)

  • 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).

Study Arms (2)

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

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

Interventions

Face-to-face survey to estimate the prevalence of current tobacco use status in the general population of Italy.

General Population

Online survey to describe patterns of use in IQOS users residing in Italy.

IQOS Users

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population will be limited to residents of Italy.

You may qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Philip Morris Products S.A.

Lausanne, 2000, Switzerland

Location

MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Pierpaolo Magnani

    Philip Morris Products S.A.

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2018

First Posted

May 16, 2018

Study Start

March 20, 2018

Primary Completion

January 31, 2020

Study Completion

January 31, 2020

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations