Exposure to harmful and potentially harmful constituents decreased in smokers switching to Carbon-Heated Tobacco Product

• Published in: Toxicology letters 2020-09, Vol.330, p.30-40
• Main Authors: Bosilkovska, Marija, Tran, Cam Tuan, de La Bourdonnaye, Guillaume, Taranu, Brindusa, Benzimra, Muriel, Haziza, Christelle
• Format: Article
• Language: English
• Subjects: Carbon-Heated Tobacco Product; Harmful and potentially harmful constituents; Heat-not-burn; Smoking
• ISSN: 0378-4274; 1879-3169
• DOI: 10.1016/j.toxlet.2020.04.013

•The Carbon-Heated Tobacco Product 1.2 (CHTP) is a disposable, single-use, heat-not-burn tobacco product designed to offer a less harmful alternative to smokers who would otherwise continue smoking.•This controlled, randomized, open-label, 2-arm parallel group study was performed in accordance with ICH GCP guidelines and the Declaration of Helsinki. The study aimed to demonstrate a reduction in the levels of biomarkers of exposure (BoExp) and associated health effects by measuring biomarkers of effect.•During the confinement period, all subjects in both arms were compliant. Only 17 subjects in the CHTP arm were non-compliant during the ambulatory period.•Compared to cigarette smoking, switching to CHTP for 5 days resulted in significant reductions in BoExp to HPHCs (40%–95%) that were sustained after 85 days of ambulatory CHTP use (36%–93%).•Compared with cigarette smoking, the use of CHTP for 90 days resulted in favorable changes in biomarkers involved in inflammation, lipid metabolism, endothelial dysfunction, platelet activation, and oxidative stress, moving in the same direction as reported in the literature for smoking cessation.•Safety information was recorded for healthy smoking subjects using CHTP, compared with those continuing to smoke cigarettes in a confinement setting for 5 days, followed by an ambulatory setting of 85 days.•The incidence of subjects experiencing AEs was comparable in the CHTP and cigarette arms. The majority of AEs reported during the study were mild or moderate in severity. “Heat-not-burn” tobacco products are designed to heat processed tobacco instead of combusting it, thus significantly reducing the formation of harmful and potentially harmful constituents (HPHCs) found in cigarette smoke, and ultimately reducing the risk of smoking-related diseases. The Carbon-Heated Tobacco Product (CHTP), a heat-not-burn tobacco product similar in appearance and use ritual to cigarettes, has been developed for smokers who would otherwise continue smoking as an alternative to cigarettes. To evaluate reduced risk of harm potential of CHTP, it is critical to quantify exposure to HPHCs and consequent biological pathway disturbances involved in disease onset in smokers who switch to CHTP. In this 2-arm, parallel-group study, adult healthy smokers, not willing to quit, were randomized to switch to CHTP 1.2 (n = 80) or to continue using cigarettes (n = 40) for 5 days in confinement followed by 85 days in an ambulatory setting. Endpoints includ