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

• ClinicalTrials.gov Identifier: NCT03527017
• Recruitment Status: Unknown
• First Posted: May 16, 2018
• Last Update Posted: April 18, 2019
• Sponsor: Philip Morris Products S.A.
• Information provided by (Responsible Party): Philip Morris Products S.A.

Tracking Information

• First Submitted Date: May 4, 2018
• First Posted Date: May 16, 2018
• Last Update Posted Date: April 18, 2019
• Actual Study Start Date: March 12, 2018
• Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 15, 2018)

• Prevalence of current tobacco use [ Time Frame: Study duration (3 years). ]
  Prevalence of current tobacco use status in the study population.
• Past tobacco use status [ Time Frame: Study duration (3 years). ]
  Past tobacco use status (cigarette, IQOS and other innovative products) in the study population.
• 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.
• Perceived risk [ Time Frame: Study duration (3 years). ]
  Association between patterns of use with perceived risk.
• 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 domains where IQOS may have potential benefits).

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Cross-Sectional Survey on the Use of Tobacco Products - Germany
• Official Title: Cross-Sectional Survey on the Use of Tobacco Products in the General Population and in Users of IQOS in Germany (2018-2020)
• 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.

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 Type: Observational
• Study Design: Observational Model: Other; Time Perspective: Cross-Sectional
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: The study population will be limited to residents of Germany.
• Condition: Tobacco Use

Intervention

• 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.
• Other: Survey on Use of Tobacco Products in IQOS Users
  Online survey to describe patterns of use in adult IQOS users residing in Germany.

Study Groups/Cohorts

• General Population
  Adults living in Germany.
  Intervention: Other: Survey on Use of Tobacco Products in the General Population
• 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.
  Intervention: Other: Survey on Use of Tobacco Products in IQOS Users

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: May 15, 2018): 7489
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2021
• Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Switzerland

Administrative Information

• NCT Number: NCT03527017
• Other Study ID Numbers: P1-PMX-03-GER
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Philip Morris Products S.A.
• Original Responsible Party: Same as current
• Current Study Sponsor: Philip Morris Products S.A.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Philip Morris Products S.A.
• Verification Date: April 2019