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Japanese Post-Market Cohort Study

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ClinicalTrials.gov Identifier: NCT03020667
Recruitment Status : Active, not recruiting
First Posted : January 13, 2017
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
Philip Morris Products S.A.

Brief Summary:

The objectives and endpoints of this study will be analyzed in the study population of adults legally authorized to buy tobacco products. The study will describe the patterns of use of tobacco and nicotine containing products and self-reported health outcomes and health related events in CC (Cigarette) smokers and IQOS users in Japan.

Note: The initial study record (posted to ClinicalTrials.gov) included a clinical sub-study designed to estimate population level differences in the biomarkers of exposure and clinical risk endpoints between iQOS users, CC smokers and never-smokers. However, due to low recruitment and retention of subjects, the clinical sub-study was terminated in May 2017 and the main study was terminated in March 2018. The study protocol was updated to remove the clinical sub-study objectives. This version of the study reflects the latest version of the updated study protocol.


Condition or disease
Smoking Tobacco Product

Detailed Description:

This is a prospective, observational, open cohort study of adults, legally authorized to purchase tobacco products in Japan. The study will describe the patterns of use of tobacco and nicotine containing products and self-reported health outcomes in CC smokers and IQOS users.

For IQOS users, the date of initiation of IQOS use is the trigger for all study assessments in the study. However the process will be different for CC smokers for whom assessment timing will be based on the date of enrollment. IQOS users will be enrolled into the study at least two months after initiating use of IQOS (to ensure adoption of IQOS), but less than 12 months after initiating use of IQOS. The study assessments will start at the next appropriate study time point after enrollment.

As this study is observational by design and is conducted in a post-market setting, adverse event (AE) reporting will follow the Sponsor's established post-market Safety Surveillance Procedures for spontaneously reported events. IQOS users will be reminded of the product quality complaints (including AEs) hotline that is available for all IQOS consumers in Japan.


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Study Type : Observational
Actual Enrollment : 1124 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Cohort Study in Japan to Assess the Patterns of Product Use and Changes in Health Outcomes Associated With the Use of HeatSticks With the IQOS Tobacco Heating System
Actual Study Start Date : April 2016
Actual Primary Completion Date : March 23, 2018
Estimated Study Completion Date : March 2019

Group/Cohort
IQOS Users
The criteria defining an "IQOS user" are listed in the section "Eligibility".
Cigarette (CC) Smokers
The criteria defining a "CC smoker" are listed in the section "Eligibility".



Primary Outcome Measures :
  1. Product consumption [ Time Frame: Study duration (up to 5 years) ]
    To measure the mean number of cigarettes smoked, IQOS HeatSticks used, and mean number of times of e-cigarettes used (per day and/or per week)

  2. Product use patterns [ Time Frame: Study duration (up to 5 years) ]
    To measure product use patterns over time (individual and dual/poly use patterns)

  3. Rate of product use [ Time Frame: Study duration (up to 5 years) ]
    To measure the rate of increase or decrease in product use over time

  4. Product use trajectories [ Time Frame: Study duration (up to 5 years) ]
    To measure intra-individual product use trajectories (product switching, uptake of new products, and rate of tobacco and nicotine product use transitions

  5. Tobacco and nicotine-containing products cessation [ Time Frame: Study duration (up to 5 years) ]
    To measure rate of cessation from cigarette, tobacco, and nicotine-containing products

  6. Motivations for quitting tobacco use [ Time Frame: Study duration (up to 5 years) ]
    To measure the rate and number of participants that want to quit and their reasons for quitting.

  7. Attempts to quit tobacco use [ Time Frame: Study duration (up to 5 years) ]
    To measure the rate and number of participants that attempt to quit and the characteristics of the quit attempts.

  8. Demographics of tobacco and nicotine-containing product users [ Time Frame: At baseline only ]
    To record the demographics and socioeconomic characteristics of tobacco and nicotine-containing product users

  9. Smoking History [ Time Frame: At baseline, Month 3, Month 9, Month 12, Month 24, Month 30, Month 36, Month 48, and Month 60 ]
    To record the smoking history of tobacco and nicotine-containing products users

  10. Product usage and behaviors (prior to IQOS use) [ Time Frame: At baseline, Month 3, Month 9, Month 12, Month 24, Month 30, Month 36, Month 48, and Month 60 ]
    To record tobacco and nicotine-containing product usage and behaviors, prior to IQOS use

  11. Change in Urge to Smoke [ Time Frame: At baseline, Month 3, Month 6, Month 9, and Month 12 ]
    Urge to Smoke measured by the QSU-brief (Questionnaire of Smoking Urges-brief)

  12. Subjective effects of IQOS use [ Time Frame: At baseline, Month 3, Month 6, Month 9, and Month 12, and Month 24 ]
    Measured with an adapted version of the modified Cigarette Evaluation Questionnaire (adapted mCEQ) in IQOS users.

  13. Self-reported changes since switching to the product [ Time Frame: At baseline, Month 3, Month 6, Month 9, and Month 12. ]
    Measured with the Self-Reported Changes Questionnaire (SRCQ) in IQOS users.

  14. Perceived risk [ Time Frame: At baseline, at Month 12, Month 24, Month 36, Month 48, and Month 60. ]
    Perception of risk associated with using CC, IQOS and e-cigarettes measured with the Perceived Risk Instrument (PRI-P). Measured on a scale from 0 (no risk) to 4 (very high risk).

  15. Nicotine dependence [ Time Frame: At baseline, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24, Month 30, Month 36, Month 48, and Month 60 ]
    The level of nicotine dependence of the participants, measured by the Fagerstrom Test of Nicotine Dependence (FTND) scale.

  16. Disease by product use [ Time Frame: At baseline, Month 9, Month 12, Month 24, Month 30, Month 36, Month 48, and Month 60 ]
    Measured by number of self-reported signs, symptoms and diagnoses of disease by product use.

  17. Change in Self-reported health events [ Time Frame: At baseline, Month 9, Month 12, Month 24, Month 30, Month 36, Month 48, and Month 60 ]
    Measured by recording the number of emergency room visits and/or hospitalizations, by product use.

  18. Change in frequency and intensity of cough [ Time Frame: At baseline, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24, Month 30, Month 36, Month 48, and Month 60 ]
    Measured on a Visual Analogue Scale (VAS) of 0 (not bothering me at all) to 10 (very bothersome).



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
A minimum of 4000 adults (female or male) will be enrolled into this study, including 2000 IQOS users and 2000 CC smokers.
Criteria

Inclusion Criteria:

  • Adult tobacco users in Japan (20 years of age)
  • The participant is Japanese
  • Participant is able to understand the information provided in the Informed Consent form (ICF)
  • Signed ICF
  • Willing to participate in the study and has access to the internet
  • For IQOS users:

    • Is currently using IQOS HeatSticks
    • Has used at least 100 IQOS HeatSticks in their lifetime, and
    • Has used IQOS HeatSticks for 2 months or more
  • For CC smokers:

    • Is currently using CC
    • Is not currently using IQOS HeatSticks, and
    • Has used at least 100 CC in their lifetime

Exclusion Criteria:

  • Tobacco industry employees
  • Employed by the Sponsor, CRO or Clinical Site
  • For IQOS users:

    • More than 12 months of IQOS use

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): NCT03020667


Locations
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Japan
Uwatoko Clinic
Ozone, Nagoya, Japan, 462-0825
Sponsors and Collaborators
Philip Morris Products S.A.
Investigators
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Principal Investigator: Kunihiko Uwatoko, MD Uwatoko Clinic
Study Chair: Luis Prieto, PhD Philip Morris Products S.A.

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Responsible Party: Philip Morris Products S.A.
ClinicalTrials.gov Identifier: NCT03020667     History of Changes
Other Study ID Numbers: P1-PMC-01-JP
First Posted: January 13, 2017    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Philip Morris Products S.A.:
Cigarette
IQOS
Nicotine-containing product
Tobacco