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

Sponsor
Philip Morris Products S.A. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03527017
Collaborator
(none)
7,489
1
41.7
179.6

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 Germany.

Condition or Disease Intervention/Treatment Phase
  • 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 Germany and in adult IQOS users registered in the IQOS user database of Philip Morris GmbH (Germany 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 Germany registered in the Germany IQOS User Database.

Study Design

Study Type:
Observational
Anticipated Enrollment :
7489 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 Germany (2018-2020)
Actual Study Start Date :
Mar 12, 2018
Anticipated Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Sep 1, 2021

Arms and Interventions

Arm Intervention/Treatment
General Population

Adults living in Germany.

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 Germany.

IQOS Users

Adult current IQOS users (at the time of survey) living in Germany who are registered in the Germany 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 adult IQOS users residing in Germany.

Outcome Measures

Primary Outcome Measures

  1. Prevalence of current tobacco use [Study duration (3 years).]

    Prevalence of current tobacco use status in the study population.

  2. Past tobacco use status [Study duration (3 years).]

    Past tobacco use status (cigarette, IQOS and other innovative products) in the study population.

  3. Self-reported health status [Study duration (3 years).]

    Association between self-reported health status and use of tobacco products in the study population.

  4. Perceived risk [Study duration (3 years).]

    Association between patterns of use with perceived risk.

  5. 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 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 Germany (≥18 years of age).

  • Currently residing in Germany.

  • Able to read, write and understand German.

  • 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:
NCT03527017
Other Study ID Numbers:
  • P1-PMX-03-GER
First Posted:
May 16, 2018
Last Update Posted:
Apr 18, 2019
Last Verified:
Apr 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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.

Study Results

No Results Posted as of Apr 18, 2019