Biomarkers Evaluation in Cigarettes vs Next Generation Product
Research type
Research Study
Full title
A Randomised Controlled Single-Center Open-Label Study in Healthy Subjects to Evaluate the Effect on Biomarkers of Exposure of Switching from a Combustible Cigarette to a Next Generation Product (NGP)
IRAS ID
225599
Contact name
Michael McEwan
Contact email
Sponsor organisation
British American Tobacco (Investments) Ltd
ISRCTN Number
ISRCTN80651909
Duration of Study in the UK
0 years, 3 months, 17 days
Research summary
Smoking is a leading cause of numerous human diseases including lung cancer and cardiovascular diseases. Tobacco-related health risks are assumed to be due to repeated and sustained exposure to a range of smoke toxicants. Smoking cessation mitigates an individual’s relative risks of tobacco related disease. To this end, series of global regulatory and educational initiatives to persuade people not to smoke are ongoing. Despite these efforts, smoking rates in adult populations worldwide remain at 15-25%. Therefore, reducing exposure to toxicants in people who continue to use tobacco through the development of new tobacco and nicotine products containing less toxicants (compared to conventional cigarettes) might help reducing the smoking- associated health problems.
For this purpose, the sponsor is planning this comparative clinical trial (in-clinic period of 7-8 days) to assess the level of toxicant exposure (via assessment of biomarkers of exposure) and the reaction of the body (via assessment of biomarkers of biological effects) to other smoking electronic devices as compared to conventional cigarettes.
REC name
HSC REC B
REC reference
17/NI/0065
Date of REC Opinion
2 May 2017
REC opinion
Further Information Favourable Opinion