Abstract
The objective of this study was to assess the reduction in exposure to selected harmful and potentially harmful constituents (HPHCs) after 5 days of ad libitum use of THS 2.2 in confined conditions compared to continued smoking of combustible cigarettes (CC) and smoking abstinence (SA).
The open-label, randomized, controlled, 3-arm parallel group, confinement study was done in 160 healthy Japanese smokers aged between 23 and 65 years. Smokers smoked their CC at baseline for 2 days, and were subsequently randomized to continue to smoke CC, to switch to THS 2.2, or to stop smoking for 5 days. Biomarkers of exposure (BoExp) to 14 HPHCs were evaluated using validated analytical methods. This study was conducted in Japan according to ICH GCP and is registered in ClinicalTrials.gov, number NCT01970982.
The average daily product use between baseline and the end of exposure was similar in the THS 2.2 and CC arms. The total nicotine exposure measured as nicotine equivalents was also similar in both arms throughout the exposure period. The levels of evaluable BoExp were significantly reduced in the range of 47% to 96% in the THS 2.2 arm as compared to CC and approaching results obtained in the SA arm. The reductions in BoExp levels could be observed within 24 hours of starting THS 2.2. THS 2.2 was well tolerated.
THS 2.2 showed a significant reduction in exposure to HPHCs after 5 days of use in confinement, as compared to CC, and approaching the levels obtained after 5 days of smoking abstinence.
Keywords: Modified risk tobacco product, Reduced exposure.
