Japanese Post-Market Cohort Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Smoking, Tobacco Product

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IQOS Users<br>The criteria defining an IQOS user are listed in the section Eligibility. | |
| Cigarette (CC) Smokers<br>The criteria defining a CC smoker are listed in the section Eligibility. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Product consumption | 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) | Study duration (up to 5 years) | 
| Product use patterns | To measure product use patterns over time (individual and dual/poly use patterns) | Study duration (up to 5 years) | 
| Rate of product use | To measure the rate of increase or decrease in product use over time | Study duration (up to 5 years) | 
| Product use trajectories | To measure intra-individual product use trajectories (product switching, uptake of new products, and rate of tobacco and nicotine product use transitions | Study duration (up to 5 years) | 
| Tobacco and nicotine-containing products cessation | To measure rate of cessation from cigarette, tobacco, and nicotine-containing products | Study duration (up to 5 years) | 
| Motivations for quitting tobacco use | To measure the rate and number of participants that want to quit and their reasons for quitting. | Study duration (up to 5 years) | 
| Attempts to quit tobacco use | To measure the rate and number of participants that attempt to quit and the characteristics of the quit attempts. | Study duration (up to 5 years) | 
| Demographics of tobacco and nicotine-containing product users | To record the demographics and socioeconomic characteristics of tobacco and nicotine-containing product users | At baseline only | 
| Smoking History | To record the smoking history of tobacco and nicotine-containing products users | At baseline, Month 3, Month 9, Month 12, Month 24, Month 30, Month 36, Month 48, and Month 60 | 
| Product usage and behaviors (prior to IQOS use) | To record tobacco and nicotine-containing product usage and behaviors, prior to IQOS use | At baseline, Month 3, Month 9, Month 12, Month 24, Month 30, Month 36, Month 48, and Month 60 | 
| Change in Urge to Smoke | Urge to Smoke measured by the QSU-brief (Questionnaire of Smoking Urges-brief) | At baseline, Month 3, Month 6, Month 9, and Month 12 | 
| Subjective effects of IQOS use | Measured with an adapted version of the modified Cigarette Evaluation Questionnaire (adapted mCEQ) in IQOS users. | At baseline, Month 3, Month 6, Month 9, and Month 12, and Month 24 | 
| Self-reported changes since switching to the product | Measured with the Self-Reported Changes Questionnaire (SRCQ) in IQOS users. | At baseline, Month 3, Month 6, Month 9, and Month 12. | 
| Perceived risk | 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). | At baseline, at Month 12, Month 24, Month 36, Month 48, and Month 60. | 
| Nicotine dependence | The level of nicotine dependence of the participants, measured by the Fagerstrom Test of Nicotine Dependence (FTND) scale. | 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 | 
| Disease by product use | Measured by number of self-reported signs, symptoms and diagnoses of disease by product use. | At baseline, Month 9, Month 12, Month 24, Month 30, Month 36, Month 48, and Month 60 | 
| Change in Self-reported health events | Measured by recording the number of emergency room visits and/or hospitalizations, by product use. | At baseline, Month 9, Month 12, Month 24, Month 30, Month 36, Month 48, and Month 60 | 
| Change in frequency and intensity of cough | Measured on a Visual Analogue Scale (VAS) of 0 (not bothering me at all) to 10 (very bothersome). | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cigarette, IQOS, Nicotine-containing product, Tobacco