A study to understand the changes after 1 year of smoking cessation
Research type
Research Study
Full title
A multi-centre, multi-region smoking cessation study to understand the biological and functional changes related to smoking cessation in healthy smokers who are continuously abstinent from smoking for one year.
IRAS ID
161975
Contact name
Minal Kara
Contact email
Sponsor organisation
Philip Morris Products S.A.
Duration of Study in the UK
1 years, 10 months, 31 days
Research summary
Cigarette smoking causes pulmonary, cardiovascular and other serious diseases. The best way for smokers to reduce the adverse health consequences of smoking is to quit. Despite the known smoking-associated risks, some smokers continue smoking. For those smokers not able or not willing to quit, Philip Morris International is developing alternative approaches with the potential to reduce the risks of tobacco-related diseases. These products are referred to as modified risk tobacco products (MRTPs).
After smoking cessation, several smoking-associated functional and biological markers (biomarkers of exposure and clinical risk endpoints) are reported to change favourably in the short and long term. These effects are sufficiently sensitive to detect changes of the smoking status, and can be used for the assessment of exposure and risk reduction potential. The observation of clinical risk endpoints after switching from conventional cigarette (CC) to a candidate MRTP compared to those with smoking cessation should be a reasonable indicator for disease risk reduction in smokers.
Philip Morris Products S.A. is the sponsor of this multi-centre smoking cessation study in healthy smokers who are continuously abstinent from smoking (free from tobacco or any nicotine containing product) for one year.
This study will investigate the clinical, biological and functional changes indicated by several smoking-associated functional and biological markers (clinical risk endpoints), and by biological markers reflecting the exposure to harmful and potentially harmful constituents in CC in smokers who are continuously abstinent from smoking for one year.
The clinical risk endpoints selected in this study are the markers with the strongest scientific evidence of favourable changes following smoking cessation. The study results will help establish a benchmark of health changes following smoking cessation.
This study will enrol participants across US, Japan and Europe, aiming to achieve 190 successful quitters with one year smoking abstinence to complete the study.REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
15/NW/0054
Date of REC Opinion
19 Feb 2015
REC opinion
Further Information Favourable Opinion