Reduced exposure evaluation of an Electrically Heated Cigarette Smoking System. Part 3: Eight-day randomized clinical...

A randomized, controlled, open-label, parallel-group, single-center study to determine biomarkers of exposure to nine selected harmful and potentially harmful constituents (HPHC) in cigarette smoke and urinary excretion of mutagenic material in 160 male and female subjects smoking Marlboro cigarettes (6 mg tar, 0.5mg nicotine, and 7.0mg CO) at baseline. Subjects were randomized to continue smoking Marlboro cigarettes, or switch to using an Electrically Heated Cigarette Smoking System (EHCSS) smoking one of two EHCSS series-K cigarettes, the EHCSS-K6 cigarette (5mg tar, 0.3mg nicotine, and 0.6 mg CO) or the EHCSS-K3 cigarette (3mg tar, 0.2mg nicotine, and 0.6 mg CO), or switch to smoking Philip Morris One cigarettes (1mg tar, 0.1mg nicotine, and 2.0mg CO), or to no-smoking. The mean decreases from baseline to Day 8 were statistically significant (p ≤ 0.05) for all determined HPHC including benzene and CO (the primary objectives), and urinary excretion of mutagenic material in the EHCSS-K6 (range -35.5 ± 29.2% to -79.4 ± 14.6% [mean ± standard deviation]), EHCSS-K3 (range -41.2 ± 26.6% to -83.1 ± 9.2%), and PM1 (range -14.6 ± 24.1% to -39.4 ± 17.5%) groups. The largest reductions in exposure occurred in the no-smoking group (range -55.4 ± 45.0% to -100.0 ± 0.0%).