Japanese Post-Market Cohort Study

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


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.


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




Uwatoko Clinic




Philip Morris Products S.A.

Results (where available)

View Results


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

Clinical Trials [997 Associated Clinical Trials listed on BioPortfolio]

Effectiveness of Reducing Smoking in Facilitating Smoking Cessation in Adolescents - 2

Currently one in five high school students smoke. Smoking can harm adolescents well before they reach adulthood by causing a number of immediate, sometimes irreversible, health risks and ...

Helping In-patients to Quit Smoking by Understanding Their Risk Perception, Behavior, and Attitudes Related to Smoking

This study aims at understanding the needs and concerns of Chinese current smoking patients, including their risk perceptions, and the behavior, attitudes, and experiences related to smoki...

"VIBRATIONS" - A Study In Smokers Who Are Willing And Motivated To Stop Smoking With The Aid Of Varenicline Which Will Be Prescribed According To Usual Clinical Practice In Germany

The aim of this study is to determine the success rates for stopping smoking with varenicline in Germany. The main measure of success will be continuous abstinence from smoking (not a sing...

Pain and Smoking Study

This purpose of this study is to test the telephone delivery of a cognitive behavioral intervention (CBI), for smoking cessation among Veteran smokers with chronic pain.

Smoking Cessation in Workplaces in Hong Kong

This study has the following objectives: 1. To examine the employers'/managerial staff's knowledge, attitudes and practices in promoting smoking cessation in workplace. 2....

PubMed Articles [991 Associated PubMed Articles listed on BioPortfolio]

The visibility of smoking in Europe and its relationship with youth's positive beliefs about smoking.

To determine adolescent-reported visibility of smoking in different public and private spaces in Europe and associations between smoking visibility and beliefs about the benefits of smoking.

Gender-Specific Blood Pressure and Heart Rate Differences in Adolescents Smoking Cigarettes, Waterpipes or Both.

The effect of concurrent cigarette and waterpipe (i.e. both) smoking on cardiovascular function is still a scarce, especially among adolescents. Therefore, the study aimed at comparing cardiovascular...

Short-Term Success Rates of Smoking Cessation Support Programs and Factors Predicting Smoking Relapse: Using Data from a Smoking Cessation Clinic in a Hospital.

Although the number of medical institutions running a smoking cessation clinic is on the rise, there remains a paucity of research on the long- and short-term success rates of smoking cessation progra...

Self-efficacy as a pathway to long-term smoking cessation among low-income parents in the multilevel Kids Safe and Smokefree intervention.

This study investigated the effects of a multi-level smoking intervention on mediators of long-term abstinence in parental smokers, including smoking cessation self-efficacy, smoking urge coping, and ...

Association Between Cigarette Smoking and Multiple Sclerosis: A Review.

Cigarette smoking is a common environmental exposure and addiction, which has severe health consequences. Smoking is a risk factor for multiple sclerosis (MS); also, smoking has been associated with d...

Medical and Biotech [MESH] Definitions

A decrease in the incidence and frequency of SMOKING. Smoking reduction differs from SMOKING CESSATION in that the smoker continues to smoke albeit at a lesser frequency without quitting.

Pipes for smoking tobacco, cannabis, and other substances, in which smoke is drawn through water. Do not confuse with SMOKING PIPES.

Gadgets, utensils, apparatuses or instruments used for SMOKING.

Devices used for SMOKING which convey SMOKE directly into the mouth.

Discontinuation of the habit of smoking, the inhaling and exhaling of tobacco smoke.

More From BioPortfolio on "Japanese Post-Market Cohort Study"

Quick Search

Relevant Topics

Biological Therapy
Biological therapy involves the use of living organisms, substances derived from living organisms, or laboratory-produced versions of such substances to treat disease. Some biological therapies for cancer use vaccines or bacteria to stimulate the body&rs...

Blood is a specialized bodily fluid that delivers necessary substances to the body's cells (in animals) – such as nutrients and oxygen – and transports waste products away from those same cells.  In vertebrates, it is composed of blo...

Benign Prostatic Hyperplasia (BPH) Erectile Dysfunction Urology Urology is the branch of medicine concerned with the urinary tract and diseases that affect it. Examples include urethritis, urethrostenosis and incontinence. Urology is a su...

Searches Linking to this Trial