A randomised, controlled, two-Centre open-label study in healthy Japanese subjects to evaluate the effect on biomarkers of exposure of switching from a conventional cigarette to a tobacco heating product

BMC Public Health

Volumn 17, Issue 1, 2017, Pages

  Gale, Nathan ^a   McEwan, Mike ^a   Eldridge, Alison C ^a   Sherwood, Neil ^b   Bowen, Edward ^c   McDermott, Simon ^d   Holmes, Emma ^d   Hedge, Andrew ^d   Hossack, Stuart ^d   Camacho, Oscar M ^a   Errington, Graham ^a   McAughey, John ^a   Murphy, James ^a   Liu, Chuan ^a   Proctor, Christopher J ^a   Fearon, Ian M ^a  

^a BRITISH AMERICAN TOBACCO   (United Kingdom)

^b Neil Sherwood Consulting   (Switzerland)

^c Late Stage Developmental Services Covance Inc   (United Kingdom)

^d Early Clinical Development   (United Kingdom)

Author keywords

Biomarker of exposure; Harm reduction; Smoking; Tobacco heating product

Indexed keywords

BIOLOGICAL MARKER;

ADULT; BREATH ANALYSIS; CLINICAL TRIAL; CONTROLLED STUDY; FEMALE; HEATING; HUMAN; JAPAN; MALE; MIDDLE AGED; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL; SMOKING; STATISTICS AND NUMERICAL DATA; TOBACCO; URINE; YOUNG ADULT;

ADULT; BIOMARKERS; BREATH TESTS; FEMALE; HEATING; HUMANS; JAPAN; MALE; MIDDLE AGED; SMOKING; TOBACCO PRODUCTS; YOUNG ADULT;

EID: 85028020562     PISSN: None     EISSN: 14712458     Source Type: Journal    
DOI: 10.1186/s12889-017-4678-9     Document Type: Article

References (34)

1. Benowitz NL. Pharmacology of nicotine: addiction, smoking-induced disease, and therapeutics. Annu Rev Pharmacol Toxicol. 2009;49:57-71.
2. Blaszkewicz M, Liesenhoff-Henze K. Creatinine in urine [Biomonitoring Methods, 2010]. In: Deutsche Forschungsgemeinschaft, editors. The MAK Collection for Occupational Health and Safety. Weinheim: Wiley-VCH Verlag GmbH; 2012. p. 169-84.
3. Digard H, Proctor C, Kulasekaran A, Malmqvist U, Richter A. Determination of nicotine absorption from multiple tobacco products and nicotine gum. Nicotine Tob Res. 2013;15(1):255-61.
4. Dittrich DJ, Fieblekorn RT, Bevan MJ, Rushforth D, Murphy JJ, Ashley M, McAdam KG, Liu C, Proctor CJ. Approaches for the design of reduced toxicant emission cigarettes. Spring. 2014;3:374.
5. Doll R, Peto R, Wheatley K, Gray R, Sutherland I. Mortality in relation to smoking: 40 years' observations on male British doctors. Br Med J. 1994;309(6959):901-11.
6. Fagerström K. Determinants of tobacco use and renaming the FTND to the Fagerstrom test for cigarette dependence. Nicotine Tob Res. 2012;14(1):75-8.
7. Fearon IM, Eldridge E, Gale N, Shepperd CJ, McEwan M, Camacho OM, Nides M, McAdam K, Proctor CJ. E-cigarette nicotine delivery: data and Learnings from pharmacokinetic studies. Am J Health Behav. 2017;41:16-32.
8. Feng S, et al. Analysis of urinary 4-aminobiphenyl, 2-aminonaphthalene and o-toluidine as biomarkers of exposure to cigarette smoke. Poster at Annual Meeting of the American College of Clinical Pharmacology, Cambridge, MA, September 2006. J Clin Pharm. 2006;46(9):1094.
9. Frost-Pineda K, Zedler BK, Oliveri D, Feng S, Liang Q, Roethig HJ. Short-term clinical exposure evaluation of a third-generation electrically heated cigarette smoking system (EHCSS) in adult smokers. Regul Toxicol Pharmacol. 2008;52:104-10.
10. Hankinson JL, Odencrantz JR, Fedan KB. Spirometric reference values from a sample of the general U.S. population. Am J Respir Crit Care Med. 1999;159(1):179-87.
11. Haswell LE, et al. A cross-sectional analysis of candidate biomarkers of biological effect in smokers, never-smokers and ex-smokers. Biomarkers. 2014;19(5):256-367.
12. Haziza C, de La Bourdonnaye G, Merlet S, Benzimra M, Ancerewicz J, Donelli A, Baker G, Picavet P, Lüdicke F. Assessment of the reduction in levels of exposure to harmful and potentially harmful constituents in Japanese subjects using a novel tobacco heating system compared with conventional cigarettes and smoking abstinence: a randomized controlled study in confinement. Regul Toxicol Pharmacol. 2016;81:489-99.
13. IARC (International Agency for Research on Cancer). Handbooks of cancer prevention: reversal of risk upon quitting smoking. Vol 11. Geneva: WHO Press; 2007.
14. IOM (Institute of Medicine). Clearing the smoke - assessing the science base for tobacco harm reduction. Washington, DC: The National Academies Press; 2001.
15. Kavvadias D, et al. Determination of tobacco-specific N-nitrosamines in urine of smokers and non-smokers. Biomarkers. 2009;14:547-53.
16. Kavvadias D, et al. Simultaneous determination of four tobacco-specific Nnitrosamines (TSNA) in human urine. J Chromatogr B Analyt Technol Biomed Life Sci. 2009;877:1185-92.
17. Lüdicke F, Haziza C, Weitkunat R, Magnette J. Evaluation of biomarkers of exposure in smokers switching to a carbon heated tobacco product: a controlled, randomized, open-label 5-day exposure study. Nicotine Tob Res. 2016;18(7):1606-13.
18. Lunell E, Molander L, Ekberg K, Wahren J. Site of nicotine absorption from a vapour inhaler - comparison with cigarette smoking. Eur J Clin Pharmacol. 2000;55(10):737-41.
19. Mackay J, Eriksen M, WHO (World Health Organization). The tobacco Altas. Geneva: World Health Organization; 2002.
20. Martin Leroy C, Jarus-Dziedzic K, Ancerewicz J, Lindner D, Kulesza A, Magnette J. Reduced exposure evaluation of an electrically heated cigarette smoking system. Part 7: a one-month, randomized, ambulatory, controlled clinical study in Poland. Regul Toxicol Pharmacol. 2012;64(2 Suppl):S74-84.
21. Miller MR, Hankinson J, Brusasco V, et al. Standardisation of spirometry. Eur Respir J. 2005;26(2):319-38.
22. Perfetti T, Rodgman A. The complexity of tobacco and tobacco smoke. Beiträge zur Tabakforschung / Contributions to Tobacco Research. 2014;24(5):215-32.
23. Picavet P, Haziza C, Lama N, Weitkunat R, Lüdicke F. Comparison of the pharmacokinetics of nicotine following single and ad Libitum use of a tobacco heating system or combustible cigarettes. Nicotine Tob Res. 2016;18(5):557-63.
24. Piller M, et al. Simple, fast and sensitive LC-MS/MS analysis for the simultaneous quantification of nicotine and 10 of its major metabolites. J Chromatogr B Analyt Technol Biomed Life Sci. 2014;951-952:7-15.
25. Pluym N, et al. Analysis of 18 urinary mercapturic acids by two high throughput multiplex-LC-MS/MS methods. Anal Bioanal Chem. 2015;407:5463-76.
26. Riedel K, et al. Determination of three carcinogenic aromatic amines in urine of smokers and nonsmokers. J Anal Toxicol. 2006;30:187-95.
27. Royal College of Physicians. Nicotine without smoke: tobacco harm reduction. London: RCP; 2016.
28. Sakaguchi C, Kakehi A, Minami N, Kikuchi A, Futamura Y. Exposure evaluation of adult male Japanese smokers switched to a heated cigarette in a controlled clinical setting. Regul Toxicol Pharmacol. 2014;69:338-47.
29. Shepperd CJ, et al. A study to estimate and correlate cigarette smoke exposure in smokers in Germany as determined by filter analysis and biomarkers of exposure. Regul Toxicol Pharmacol. 2009;55(1):97-109.
30. Shepperd CJ, Eldridge A, Camacho OM, McAdam K, Proctor CJ, Meyer I. Changes in levels of biomarkers of exposure observed in a controlled study of smokers switched from conventional to reduced toxicant prototype cigarettes. Regul Toxicol Pharmacol. 2013;66:147-62.
31. Shepperd CJ, Newland N, Eldridge A, Haswell L, Lowe F, Papadopoulou E, Camacho O, Proctor CJ, Graff D, Meyer I. Changes in levels of biomarkers of exposure and biological effect in a controlled study of smokers switched from conventional cigarettes to reduced-toxicant-prototype cigarettes. Reg Tox Pharmacol. 2015;72:273-91.
32. Stratton K, Shetty P, Wallace R, Bondurant S. Clearing the smoke: the science base for tobacco harm reduction - executive summary. Tob Control. 2001;10(2):189-95.
33. Tricker AR, Jang IJ, Martin Leroy C, Lindner D, Dempsey R. Reduced exposure evaluation of an electrically heated cigarette smoking system. Part 4: eight-day randomized clinical trial in Korea. Regul Toxicol Pharmacol. 2012;64(2 Suppl):S45-53.
34. WHO (World Health Organization). WHO report on the global tobacco epidemic: Warning about the dangers of tobacco. Geneva: WHO Press; 2011.