Smoking Clinical Trial - Japanese Post-Market Cohort Study

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03020667
Study type	Observational
Source	Philip Morris Products S.A.
Contact
Status	Active, not recruiting
Phase
Start date	April 2016
Completion date	March 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03999411` - Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients	Phase 4
Completed	`NCT03931772` - Online Automated Self-Hypnosis Program	N/A
Completed	`NCT02649556` - A 26-week Extension of the ZRHR-ERS-09-US Study Evaluating Biological and Functional Changes in Healthy Smokers After Switching to THS 2.2	N/A
Completed	`NCT03901066` - Smoking Dependence and Periodontitis
Recruiting	`NCT05846841` - Personalized Tobacco Treatment in Primary Care (MOTIVATE)	N/A
Completed	`NCT03170752` - Implementing and Testing a Cardiovascular Assessment Screening Program (CASP)	N/A
Completed	`NCT03305978` - Pulmonary Nodule Detection: Comparison of an Ultra Low Dose vs Standard Scan.	N/A
Completed	`NCT00000437` - Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)	Phase 4
Completed	`NCT06105424` - BRP1602: Evaluation of Technical and Logistical Feasibility to Measure Lung Permeability	N/A
Active, not recruiting	`NCT02752022` - Monitoring the Transition From Smoking to E-cigarettes
Completed	`NCT04340830` - The Effect of Smoking on Dimensional Changes of Free Gingival Graft Around Dental Implants	N/A
Completed	`NCT02912000` - TEACH: Technology Evaluation to Address Child Health	N/A
Completed	`NCT03206619` - A Health Recommeder System to Tailor Message Preferences in a Smoking Cessation Programme
Completed	`NCT02901171` - The Contribution of a Smartphone Application to Acceptance and Commitment Therapy Group Treatment for Smoking Cessation	N/A
Completed	`NCT02949648` - Electronic Cigarette Use and Quitting in Youth	N/A
Completed	`NCT02246114` - Self-Monitoring of Carbon Monoxide to Enhance Reproductive Outcomes in Women	N/A
Completed	`NCT02945371` - Tailored Inhibitory Control Training to Reverse EA-linked Deficits in Mid-life	N/A
Completed	`NCT03448900` - Intervention Study for Smoking Cessation in Spanish College Students	N/A
Completed	`NCT02008292` - Acetylcholine, Tobacco Smoking, Genes and Nicotinic Receptors	N/A
Completed	`NCT01954407` - Young Adults' Responses to Anti-smoking Messages	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.