title: Reduced exposure evaluation of an Electrically Heated Cigarette Smoking System. Part 5: 8-Day randomized clinical trial in Japan.
abstract: A randomized, controlled, open-label, parallel-group, single-center study to determine biomarkers of exposure to twelve selected harmful and potentially harmful constituents (HPHCs) in cigarette smoke and urinary excretion of mutagenic material in 128 male and female Japanese 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 the Electrically Heated Cigarette Smoking System (EHCSS) and smoke either the EHCSS-K6 (5mg tar, 0.3mg nicotine, and 0.6 mg CO) or the EHCSS-K3 (3mg tar, 0.2mg nicotine, and 0.6 mg CO) cigarette, or switch to smoking Lark 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 cigarette smoke HPHC including CO (the primary objective) and excretion of mutagenic material in the EHCSS-K6 (range: -14.6% to -75.6%) and EHCSS-K3 (range: -9.8% to -73.0%) groups. Statistically significant reductions (all p ≤ 0.05) in exposure to ten cigarette smoke HPHC (range: -5.9% to -34.6%), but not urinary mutagenicity, were observed in the Lark One group. The largest mean reductions in exposure to HPHC (all p ≤ 0.01 level) occurred in the no-smoking group (range: -13.7% to -97.6%).
authors.affiliation: Philip Morris International R&D, Philip Morris Products SA, Quai Jeanrenaud 5, 2000 Neuchâtel, Switzerland. Anthony.Tricker@pmi.com
authors.forename: Anthony R
authors.initials: AR
authors.lastname: Tricker
authors.forename: Shigeto
authors.initials: S
authors.lastname: Kanada
authors.forename: Kohji
authors.initials: K
authors.lastname: Takada
authors.forename: Claire Martin
authors.initials: CM
authors.lastname: Leroy
authors.forename: Dirk
authors.initials: D
authors.lastname: Lindner
authors.forename: Matthias K
authors.initials: MK
authors.lastname: Schorp
authors.forename: Ruth
authors.initials: R
authors.lastname: Dempsey
mesh_terms: D000328:Adult; D015415:Biomarkers / Q000097:blood / Q000652:urine; D002263:Carboxyhemoglobin / Q000032:analysis; D004560:Electricity; D005260:Female; D006358:Hot Temperature; D006801:Humans; D019570:Inhalation Exposure / Q000009:adverse effects* / Q000032:analysis; D007564:Japan; D008297:Male; D008875:Middle Aged; D012907:Smoking / Q000009:adverse effects / Q000097:blood* / Q000652:urine*; D013997:Time Factors; D062789:Tobacco Products / Q000032:analysis* / Q000633:toxicity; D014028:Tobacco Smoke Pollution / Q000009:adverse effects / Q000032:analysis* / Q000517:prevention & control; D055815:Young Adult
chemical_list: D015415:Biomarkers; D014028:Tobacco Smoke Pollution; D002263:Carboxyhemoglobin