Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03527017
Recruitment Status : Unknown
Verified April 2019 by Philip Morris Products S.A..
Recruitment status was:  Recruiting
First Posted : May 16, 2018
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Philip Morris Products S.A.

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
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 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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated 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 : March 12, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort 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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 domains where IQOS may have potential benefits).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 Germany.
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03527017


Contacts
Layout table for location contacts
Contact: Luis Prieto, PhD +41 58 242 11 11 luis.prieto@pmi.com

Locations
Layout table for location information
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
Layout table for investigator information
Study Chair: Luis Prieto, PhD Philip Morris Products S.A.
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Philip Morris Products S.A.
ClinicalTrials.gov Identifier: NCT03527017    
Other Study ID Numbers: P1-PMX-03-GER
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

Layout table for additional information
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