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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03527004
Recruitment Status : Recruiting
First Posted : May 16, 2018
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Philip Morris Products S.A.

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
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:

  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.

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Study Type : Observational
Estimated 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 : March 20, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Prevalence of current tobacco use [ Time Frame: Study duration (3 years). ]
    Prevalence of current tobacco use status in the study population.

  2. Past tobacco use status [ Time Frame: Study duration (3 years). ]
    Past tobacco use status (cigarette, IQOS and other innovative products) in the study population.

  3. 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.

  4. Perceived risk [ Time Frame: Study duration (3 years). ]
    Association between patterns of use with perceived risk.

  5. 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 relevant domains where IQOS may have potential benefits).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The study population will be limited to residents of Italy.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03527004


Contacts
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Contact: Luis Prieto, PhD +41 58 242 11 11 luis.prieto@pmi.com

Locations
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Switzerland
Philip Morris Products S.A. Recruiting
Neuchâtel, Switzerland, 2000
Contact: Luis Prieto, PhD    +41 (58) 242 2698    Luis.Prieto@pmi.com   
Sponsors and Collaborators
Philip Morris Products S.A.
Investigators
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Study Chair: Luis Prieto, PhD Philip Morris Products S.A.
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Responsible Party: Philip Morris Products S.A.
ClinicalTrials.gov Identifier: NCT03527004    
Other Study ID Numbers: P1-PMX-02-IT
First Posted: May 16, 2018    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Philip Morris Products S.A.:
Tobacco Use
IQOS