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

Shepperd, Christopher J.; Newland, Nik; Eldridge, Alison; Haswell, Linsey E.; Lowe, Frazer; Papadopoulou, Ermioni; Camacho, Oscar M.; Proctor, Christopher; Graff, Don; Meyer, Ingo

doi:10.1016/j.yrtph.2015.04.016

Cited by 27 publications

(24 citation statements)

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“…A maximum daily limit of product use will be specified, based on 120% of subjects’ usual cigarette consumption, to prevent subjects from smoking to a degree greater than they would normally. Such an uplift in smoking behaviour has been observed during clinical studies with cigarettes [ 31 ]. During the pharmacokinetic phase, subjects will be requested to smoke 1 cigarette/THP at a specified time.…”

Section: Methodsmentioning

confidence: 75%

“…This is based on powering the primary objective of within-group comparison of biomarker levels at baseline and end-of-study. The calculation was based on the number of pairs required to perform a paired t-test with 80% power for a decrease in biomarker levels of 40% or more compared to historical biomarker data available for a 7 mg ISO tar conventional cigarette ([ 4 ], [ 31 ]). A sample size of 30 was determined to be adequate based on the biomarker requiring the most pairs to power (eCO) and allowing for attrition.…”

Section: Methodsmentioning

confidence: 99%

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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

et al. 2017

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BackgroundSmoking is a leading cause of numerous human disorders including lung cancer, chronic obstructive pulmonary disease, and atherosclerotic cardiovascular disease. The development of modified risk tobacco products (MRTPs) has been suggested as a possible way to reduce the risks of tobacco smoking by reducing exposure to cigarette smoke toxicants. This study is designed to investigate whether biomarkers of such exposure are reduced when smokers switch from smoking commercial cigarettes to using either a novel or a commercially-available tobacco heating product (THP).Design and MethodsThis study will assess biomarkers of exposure in current smokers who either remain smoking, switch to THP use, or quit all tobacco use completely, for 5 days. The study is an in-clinic (confinement) two-centre, randomised controlled clinical study with a forced-switching design.Subjects of either gender will be aged 23–55 years (minimum legal smoking age plus 3 years), of Japanese origin and with a verified smoking status (assessed by exhaled breath carbon monoxide and urinary cotinine levels). Subjects will have a usual brand cigarette within the International Organisation for Standardisation (ISO) tar band of 6-8 mg and will be judged to be healthy by medical history, physical examination, vital signs, electrocardiography (ECG), clinical biochemistry and lung function tests.The primary objective of this study is to assess changes within groups in selected biomarkers of exposure (BoE) and of biological effect (BoBE) after a forced switch from a commercial control cigarette to either a menthol or a non-menthol THP. Secondary objectives are to assess between-group differences, to determine nicotine pharmacokinetics for cigarettes and THPs, to assess subject’s satisfaction with the study products, and to monitor additional endpoints related to safety and product use.DiscussionData from this study will advance our scientific understanding of the changes in exposure to cigarette smoke toxicants in smokers who switch to using a THP.Trial registrations UMIN000024988 (25th November 2016); ISRCTN14301360 (14th December 2016)Electronic supplementary materialThe online version of this article (doi:10.1186/s12889-017-4678-9) contains supplementary material, which is available to authorized users.

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Section: Methodsmentioning

confidence: 75%

Section: Methodsmentioning

confidence: 99%

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

et al. 2017

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“…Moreover, changes in biomarkers of exposure (BoE) may not be uniform. For example, although a significant decrease in acrolein has been reported after use of reduced risk tobacco products, substantial increases were seen in BoE levels for fluorene and naphthalene in the same study population (5).…”

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confidence: 70%

Acrolein Levels in e-Cigarettes—Letter

Polosa

Caruso

Caponnetto

2016

Cancer Prevention Research

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“…Synthetic PD carbon could be used to reduce selected mainstream smoke constituents and may assist with mandated reductions for some toxicants. However, reduced exposure does not necessarily mean reduced risk (16), and the impact of any reduction in smoke constituents on smokers' health is unknown. Reduction in smokers' total exposure is dependent on them not increasing their cigarette consumption or smoking more intensely.…”

Section: Discussionmentioning

confidence: 99%

“…Typically, coconut-shell derived (CSD) carbon is used in cigarette filters, but a synthetic polymer-derived (PD) carbon (Blücher GmbH, Erkrath, Germany) is approximately twice as effective in removing many vapour phase toxicants (14). Cigarette designs that included PD carbon in the filter have reduced smokers' exposure to some toxicants, but the level of influence of the PD carbon could not be separated from that of other design differences (15)(16)(17).…”

Section: Resumementioning

confidence: 99%

Influence of Type and Amount of Carbon in Cigarette Filters on Smokers’ Mouth Level Exposure to “Tar”, Nicotine, 1,3-Butadiene, Benzene, Toluene, Isoprene, and Acrylonitrile

Nother¹,

Ashley²,

Clayton³

2016

Beiträge Zur Tabakforschung International/Contributions to Tobacco Research

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Summary Activated carbons are effective adsorbents for many volatile organic compounds and are used in cigarette filters to remove selected smoke toxicants. Polymer-derived carbon is more effective in removing many vapour phase toxicants found in cigarette smoke than coconut-shell-derived carbon. We compared mouth-level exposure to “tar”, nicotine and five vapour phase constituents (1,3- butadiene, benzene, toluene, isoprene, acrylonitrile) in two groups of Romanian smokers of 4-mg or 8-mg International Organization for Standardization (ISO) “tar” bands. Test cigarettes with 4 and 8 mg ISO “tar” were manufactured for the study with two target levels of polymer-derived carbon (30 mg and 56 mg), along with control cigarettes containing a target level of 56 mg of coconut-shell-derived carbon in both “tar” bands. No significant differences were found between mouth-level exposure to “tar” or nicotine yields obtained from control and test products (p > 0.05) in either ISO “tar” band. Mouth-level exposure to each of the five vapour phase constituents was significantly lower from the test products with polymer-derived carbon (p < 0.0001) than from control cigarettes with coconut-shell-derived carbon, by an average of 25% with 30 mg polymer-derived carbon and around 50% with 56 mg. [Beitr. Tabakforsch. Int. 27 (2016) 40-53]

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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

Abstract: Despite increased cigarette consumption, reductions in BoE and BoED were detectable.

Cited by 27 publications

References 60 publications

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

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

Acrolein Levels in e-Cigarettes—Letter

Influence of Type and Amount of Carbon in Cigarette Filters on Smokers’ Mouth Level Exposure to “Tar”, Nicotine, 1,3-Butadiene, Benzene, Toluene, Isoprene, and Acrylonitrile

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