Japanese Post-Market Cohort Study

• Conditions: Tobacco Product; Smoking

• Registration Number: NCT03020667
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-11-17
• Study First Submitted QC: 2017-01-11
• Study First Posted: 2017-01-13
• Primary Completion: 2018-03-23
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-06
• Last Update Posted: 2018-09-07
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1124

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

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Exclusion Criteria

• Tobacco industry employees

• Employed by the Sponsor, CRO or Clinical Site

• For IQOS users:

  • More than 12 months of IQOS use

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Product Consumption	CC smokers: enrollment, IQOS users: 3-18 Months IQOS use time	To measure the mean numbers of cigarettes smoked and IQOS with HeatSticks used, mean numbers/times of Other Tobacco and Nicotine containing Products (OTP) used. OTP: included all other tobacco and nicotine-containing products except IQOS.
Product Use Patterns	IQOS users: 3-18 months IQOS use, CC smokers from enrollment up to 15 months of follow-up	To describe product use patterns in CC smokers and IQOS users by product use categories.; Primarily IQOS: ≥70% consumption of IQOS, Primarily CC: ≥70% consumption of CC, Mixed IQOS-CC: consumption of IQOS in (30% to 70%) AND consumption of CC in (30% to 70%), Mixed IQOS-OTP: consumption of IQOS in (30% to 70%) AND consumption of OTP in (30% to 70%), Mixed CC-OTP: consumption of CC in (30% to 70%) AND consumption of OTP in (30% to 70%), Non-User/smoker: Total consumption of all products = 0, Other: Does not fit in any of the above categories and no 'missing'.
Rate of Product Use	IQOS users: 3-18 months IQOS use time	To measure the percentage of product use in IQOS users based on IQOS use time.; * IQOSi = percentage of IQOS use at time point i,; * CCi = percentage of CC use at time point i,; * OTPi = percentage of other tobacco products (OTP) use at time point i.
Tobacco and Nicotine-containing Products Cessation	IQOS users: 3-18 months IQOS use time, CC smokers from enrollment up to 15 months of follow-up	To measure rate of cessation from all tobacco and nicotine-containing products in CC smokers and IQOS users
Demographics of Tobacco and Nicotine-containing Product Users	IQOS users at enrollment	To describe the demographics characteristics of IQOS users by product use category: Primarily IQOS: ≥70% consumption of IQOS, Primarily CC: ≥70% consumption of CC, Mixed IQOS-CC: consumption of IQOS in (30% to 70%) AND consumption of CC in (30% to 70%), Mixed IQOS-OTP: consumption of IQOS in (30% to 70%) AND consumption of OTP in (30% to 70%), Mixed CC-OTP: consumption of CC in (30% to 70%) AND consumption of OTP in (30% to 70%), Non-Use: Total consumption of all products= 0, Other: Does not fit in any of the above categories and no 'missing'.
Smoking History (Duration)	At enrollment	To record the smoking history (duration) in CC smokers and IQOS users, measured in years.
Smoking History (Intensity)	At enrollment	To record the smoking history (intensity) in CC smokers and IQOS users, measured in pack-years. One pack year is equivalent to smoking 20 cigarettes a day for one year.
Product Usage and Behaviors (Prior to IQOS Use): Smoking Duration	From enrollment up to 15 months follow-up	To measure smoking duration among CC smokers who started to use IQOS during follow-up, measured in years.
Product Usage and Behaviors (Prior to IQOS Use): Smoking Intensity	From enrollment up to 15 months follow-up	To measure smoking intensity among CC smokers who started to use IQOS during follow-up, measured in pack years. One pack year is equivalent to smoking 20 cigarettes a day for one year.

Trial Locations

Locations (1)

Uwatoko Clinic; 🇯🇵 Ozone, Nagoya, Japan