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Japanese Post-Market Cohort Study

2017-01-17 06:20:57 | BioPortfolio

Summary

The Tobacco Heating System (THS 2.2) which is commercialized under the iQOS brand name (as described in the study protocol) in Japan is subject to an assessment program which includes post-market studies such as the Japanese Post-Market Cohort Study.

The objectives and endpoints of this Post-Market Cohort Study will be analyzed in the study population of adult tobacco users and never smokers in Japan. This includes:

- Provide a perspective of tobacco product use in a "real world setting", where simultaneous use of tobacco and nicotine containing products may occur,

- Describe population-level changes in biomarkers of exposure (BoExp) following long duration of CC and THS 2.2 use,

- Evaluate whether there is a difference in the levels of selected clinical risk endpoints (CREs) between CC smokers and THS 2.2 users.

This study is divided in 2:

- Main Study: the Main Study will describe the patterns of use of tobacco and nicotine containing products and self-reported health outcomes and health related events in CC smokers and THS 2.2 users. THS 2.2 users and CC smokers will be identified and invited for participation in the study until each annual wave of 500 participants for each product is filled.

- Clinical Sub-Study: the Clinical Sub-Study will further assess the population level differences in BoExp to harmful and potentially harmful constituents (HPHCs), CREs, and self-reported symptoms and health outcomes between CC smokers, THS 2.2 users and never-smokers, the latter group only included in the Clinical Sub-Study. THS 2.2 users enrolled in the Main Study will be invited to enroll in the Clinical Sub-Study where clinical assessments will be performed and biological samples (blood, serum, plasma, and urine) will be collected. There will be two clinical study visits, which will take place at Month 12 (Visit 1) and Month 36 post product initiation (Visit 2).

Participants will be recruited into the cohort in annual waves over a period of 4 years.

Description

For THS 2.2 users, the date of initiation of THS 2.2 use is the trigger for all study assessments in both the Main Study and the Clinical Sub-Study.

THS 2.2 users will be enrolled into the study at least 2 months after initiating use of THS 2.2 (to ensure adoption of THS 2.2 after switching from CC), but less than 12 months after initiating use of THS 2.2 (to ensure that each annual wave targets new users), the study assessments will start at the next appropriate study time point after enrollment.

The process will be different for CC smokers in the Main Study as well as CC smokers and never-smokers in the Clinical Sub-Study. In the Main Study, the CC smoker's assessment timing will be based on the date of enrollment.

This study is an open cohort which will have a follow-up duration of up to 5 years. With a minimum follow-up per participant of 1 year.

The cohort will remain open for enrollment for the first 4 years, with annual waves of 500 THS 2.2 users and 500 CC smokers for the Main Study. 190 THS 2.2 users, 190 CC smokers and 190 never-smokers will be enrolled annually in the Clinical Sub-Study. The aim of these waves is to sample from a changing pool of THS 2.2 users in order to have a population representative sample of those who use THS 2.2.

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Conditions

Smoking

Location

Uwatoko Clinic
Nagoya
Japan
462-0825

Status

Recruiting

Source

Philip Morris Products S.A.

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-01-17T06:20:57-0500

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