Japanese Post-Market Cohort Study

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

The objectives and endpoints of this study were analyzed in the study population of adults eligible to purchase tobacco products. The study was planned to 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.

The initial study record (posted on ClinicalTrials.gov) included a clinical sub-study designed to estimate population level differences in the biomarkers of exposure and clinical risk endpoints among 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 for the same reasons the main study was terminated in March 2018. The study protocol was updated to remove the clinical sub-study objectives. The study initially included 18 outcome measures. Due to study termination leading to a shortened follow-up period and a smaller sample size, only 7 of these outcome measures could be assessed and the other outcome measures planned were either unattainable or uninformative.

Study Overview

• Status: Terminated
• Conditions: Smoking; Tobacco Product

Detailed Description

This was a prospective, observational, cohort study of adults, eligible to purchase tobacco products in Japan. The study described the patterns of use of tobacco and nicotine containing products in CC smokers and IQOS users.

For IQOS users, the date of initiation of IQOS use was the trigger for all study assessments in the study. However the process was different for CC smokers for whom assessment timing was based on the date of enrollment. IQOS users were 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 started at the next appropriate study time point after enrollment. Participants were recruited from consumer databases and/or through advertisement. Responses from all eligible participants in the study were collected online using computer assisted self-interviews (CASIs). The questionnaires included demographic information, tobacco use questionnaire including detailed product use and intention to stop tobacco- and nicotine-containing product use, lifestyle assessments, social-economic status, risk perception, nicotine dependence, urge to smoke, as well as self-reported health outcomes. IQOS users were also administered the Modified Cigarette Evaluation Questionnaire, and Self-Reported Changes Questionnaire. The CASIs were administered at the enrollment and quarterly for the first 18 months (at Months 3, 6, 9, 12, 15 and 18).

The study initially was planned to recruit 2,000 IQOS users and 2,000 cigarette (CC) smokers in 4 annual waves (500 IQOS users and 500 CC smokers per wave) and to be followed up to a maximum of 60 months. The first wave of recruitment competed in March 2017. During wave 2 recruitment the study was terminated. A total of 599 IQOS users and 525 CC smokers were enrolled. There was 1 reported protocol deviation in IQOS users, the participant had been using IQOS for 15 months. Due to study termination, only data collected for wave 1 was analyzed.

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

• Study Type: Observational
• Enrollment (Actual): 1124

Contacts and Locations

Study Locations

• Japan
  • Nagoya
    • Ozone, Nagoya, Japan, 462-0825
      • Uwatoko Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adults (female or male) Japanese IQOS users and CC smokers.

Description

Inclusion Criteria:

• Adult tobacco users in Japan (at least 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 with HeatSticks
  • Has used at least 100 HeatSticks with IQOS in their lifetime, and
  • Has used IQOS with HeatSticks for 2 months or more

• For CC smokers:

  • Is currently using CC
  • Is not currently using IQOS with 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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".

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Product Consumption	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.	CC smokers: enrollment, IQOS users: 3-18 Months IQOS use time
Product Use Patterns	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'.	IQOS users: 3-18 months IQOS use, CC smokers from enrollment up to 15 months of follow-up
Rate of Product Use	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.	IQOS users: 3-18 months IQOS use time
Tobacco and Nicotine-containing Products Cessation	To measure rate of cessation from all tobacco and nicotine-containing products in CC smokers and IQOS users	IQOS users: 3-18 months IQOS use time, CC smokers from enrollment up to 15 months of follow-up
Demographics of Tobacco and Nicotine-containing Product Users	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'.	IQOS users at enrollment
Smoking History (Duration)	To record the smoking history (duration) in CC smokers and IQOS users, measured in years.	At enrollment
Smoking History (Intensity)	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.	At enrollment
Product Usage and Behaviors (Prior to IQOS Use): Smoking Duration	To measure smoking duration among CC smokers who started to use IQOS during follow-up, measured in years.	From enrollment up to 15 months follow-up
Product Usage and Behaviors (Prior to IQOS Use): Smoking Intensity	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.	From enrollment up to 15 months follow-up

Collaborators and Investigators

• Sponsor: Philip Morris Products S.A.
• Investigators: Principal Investigator: Kunihiko Uwatoko, MD, Uwatoko Clinic; Study Chair: Pierpaolo Magnani, Philip Morris Products S.A.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): March 23, 2018
• Study Completion (Actual): May 30, 2018

Study Registration Dates

• First Submitted: November 17, 2016
• First Submitted That Met QC Criteria: January 11, 2017
• First Posted (Estimated): January 13, 2017

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Tobacco; Cigarette; IQOS; Nicotine-containing product
• Other Study ID Numbers: P1-PMC-01-JP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO