Cross-Sectional Survey on the Use of Tobacco Products in the General Population and in Users of IQOS in Germany (2018-2020)

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



Sponsors


Source

Philip Morris Products S.A.

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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.

Overall Status

Recruiting

Start Date

2018-03-12

Completion Date

2021-09-01

Primary Completion Date

2020-12-01

Study Type

Observational

Primary Outcome

Measure

Time Frame

Prevalence of current tobacco use
Study duration (3 years).
Past tobacco use status
Study duration (3 years).
Self-reported health status
Study duration (3 years).
Perceived risk
Study duration (3 years).
IQOS use experience
Study duration (3 years).

Number Of Groups

2

Enrollment

7489

Condition


Intervention

Intervention Type

Other

Intervention Name


Description

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

Arm Group Label

General Population


Intervention Type

Other

Intervention Name


Description

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

Arm Group Label

IQOS Users



Eligibility

Study Pop

The study population will be limited to residents of Germany.

Sampling Method

Probability Sample

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

Gender

All

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

Accepts Healthy Volunteers


Overall Official

Last Name

Role

Affiliation

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

Overall Contact

Last Name

Luis Prieto, PhD

Phone

+41 58 242 11 11

Email



Location

Facility

Status

Contact

Philip Morris Products S.A.
Neuchâtel 2000 Switzerland
Recruiting
Last Name: Peter Langer, PhD

Location Countries

Country

Switzerland


Verification Date

2018-05-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Sponsor


Keywords


Has Expanded Access

No

Arm Group

Arm Group Label

General Population

Description

Adults living in Germany.


Arm Group Label

IQOS Users

Description

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.



Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Peter Langer, PhD

Phone

+41 58 242 11 11


Patient Data

Sharing Ipd

No


Firstreceived Results Disposition Date

N/A

Study Design Info

Observational Model

Other

Time Perspective

Cross-Sectional


Study First Submitted

May 4, 2018

Study First Submitted Qc

May 15, 2018

Study First Posted

May 16, 2018

Last Update Submitted

May 15, 2018

Last Update Submitted Qc

May 15, 2018

Last Update Posted

May 16, 2018


ClinicalTrials.gov processed this data on August 27, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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