A randomised, parallel group study to evaluate the safety profile of an electronic vapour product over 12 weeks

Regulatory Toxicology and Pharmacology

Volumn 81, Issue , 2016, Pages S1-S14

  Cravo, Ana S ^a   Bush, Jim ^b   Sharma, Girish ^c   Savioz, Rebecca ^d   Martin, Claire ^d   Craige, Simon ^a   Walele, Tanvir ^a  

^a HN Amsterdam   (Netherlands)

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

^c SIMBEC RESEARCH LTD   (United Kingdom)

^d Clinopsis SA   (Switzerland)

Author keywords

Adverse events; Biomarkers of biological effect; Biomarkers of exposure; Cigarette; Clinical study; Electronic cigarette; Electronic vapour product; Safety; Smoking urges; Withdrawal symptoms

Indexed keywords

2 BUTANONE; 3 HYDROXYPROPYL MERCAPTURIC ACID; 4 (METHYLNITROSAMINO) 1 (3 PYRIDYL) 1 BUTANONE; ACETYLCYSTEINE; ACROLEIN; BENZENE; BENZENE DERIVATIVE; NICOTINE; PROPYLENE GLYCOL; UNCLASSIFIED DRUG; BIOLOGICAL MARKER; NICOTINIC AGENT;

ADULT; AGED; ALLERGY; ARTICLE; ATTENTION DISTURBANCE; CHEMICAL COMPOSITION; CONTROLLED STUDY; COUGHING; DRUG CRAVING; ELECTROCARDIOGRAPHY; ELECTRONIC CIGARETTE; FEMALE; HEADACHE; HUMAN; HUMAN CELL; HYPERSENSITIVITY; INCREASED APPETITE; IRRITABILITY; LUNG FUNCTION TEST; MALE; NAUSEA; OPEN STUDY; PARALLEL DESIGN; PRIORITY JOURNAL; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SAFETY; SMOKING; SMOKING CESSATION; SORE THROAT; UPPER RESPIRATORY TRACT INFECTION; URINE LEVEL; WITHDRAWAL SYNDROME; ADVERSE EFFECTS; BLOOD; CLINICAL TRIAL; INHALATIONAL DRUG ADMINISTRATION; MIDDLE AGED; MULTICENTER STUDY; PREVENTION AND CONTROL; PROCEDURES; PRODUCT SAFETY; RISK ASSESSMENT; SUBSTANCE WITHDRAWAL SYNDROME; TIME FACTOR; TOBACCO USE DISORDER; UNITED KINGDOM; URINE; VOLATILIZATION; YOUNG ADULT;

ADMINISTRATION, INHALATION; ADULT; BIOMARKERS; CONSUMER PRODUCT SAFETY; ELECTRONIC CIGARETTES; FEMALE; HUMANS; MALE; MIDDLE AGED; NICOTINE; NICOTINIC AGONISTS; RISK ASSESSMENT; SMOKING; SMOKING CESSATION; SUBSTANCE WITHDRAWAL SYNDROME; SURVEYS AND QUESTIONNAIRES; TIME FACTORS; TOBACCO USE DISORDER; UNITED KINGDOM; VOLATILIZATION; YOUNG ADULT;

EID: 84992445134     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2016.10.003     Document Type: Article

References (56)

1. Bain, B.J., et al. Acute changes in haematological parameters on cessation of smoking. J. R. Soc. Med. 85 (1992), 80–82.
2. Bedfront, Smokerlyzer Range for Use with piCO, piCObaby and Micro+ - User Manual. 2016 (Accessed 12 September 2016) http://www.bedfont.com/file/1813-LAB679_smokerlyzer_manual_issue_2.pdf.
3. Berg, C.J., et al. Cigarette users’ interest in using or switching to electronic nicotine delivery systems or smokeless tobacco for harm reduction, cessation, or novelty: a cross-sectional survey of US adults. Nicotine Tob. Res. 17 (2015), 245–255, 10.1093/ntr/ntu103.
4. Bolliger, C.T., et al. Smoking reduction with oral nicotine inhalers: double blind, randomised clinical trial of efficacy and safety. BMJ 321 (2000), 329–333.
5. Buchelli Ramirez, H., et al. Elevated carboxyhemoglobin: sources of carbon monoxide exposure. Arch. Bronconeumol. 50 (2014), 465–468, 10.1016/j.arbres.2014.03.005.
6. Bullen, C., et al. Effect of an electronic nicotine delivery device (e cigarette) on desire to smoke and withdrawal, user preferences and nicotine delivery: randomised cross-over trial. Tob. Control 19 (2010), 98–103, 10.1136/tc.2009.031567.
7. Bullen, C., et al. Electronic cigarettes for smoking cessation: a randomised controlled trial. Lancet 382 (2013), 1629–1637, 10.1016/S0140-6736(13)61842-5.
8. Cantrell, F.L., Adverse effects of e-cigarette exposures. J. Community Health 39 (2014), 614–616, 10.1007/s10900-013-9807-5.
9. Caponnetto, P., et al. EffiCiency and Safety of an eLectronic cigAreTte (ECLAT) as tobacco cigarettes substitute: a prospective 12-month randomized control design study. PLoS One, 8, 2013, e66317, 10.1371/journal.pone.0066317.
10. Chen, I.L., FDA summary of adverse events on electronic cigarettes. Nicotine Tob. Res. 15 (2013), 615–616, 10.1093/ntr/nts145.
11. Cox, L.S., et al. Evaluation of the brief questionnaire of smoking urges (QSU-brief) in laboratory and clinical settings. Nicotine Tob. Res. 3 (2001), 7–16, 10.1080/14622200020032051.
12. D'Ruiz, C.D., et al. Nicotine delivery, tolerability and reduction of smoking urge in smokers following short-term use of one brand of electronic cigarettes. BMC Public Health, 15, 2015, 991, 10.1186/s12889-015-2349-2.
13. Dicpinigaitis, P.V., et al. Effect of e-Cigarette Use on Cough Reflex Sensitivity. Chest 149 (2016), 161–165, 10.1378/chest.15-0817.
14. Dockrell, M., et al. E-Cigarettes: prevalence and attitudes in Great Britain. Nicotine Tob. Res. 15 (2013), 1737–1744, 10.1093/ntr/ntt057.
15. Dollery, C.D., Bankowski, Z., Safety Requirements for the First Use of New Drugs and Diagnostic Agents in Man. 1983, CIOMS 9290360125.
16. Etter, J.F., A longitudinal study of cotinine in long-term daily users of e-cigarettes. Drug Alcohol Depend. 160 (2016), 218–221, 10.1016/j.drugalcdep.2016.01.003.
17. Etter, J.F., et al. Analysis of refill liquids for electronic cigarettes. Addiction 108 (2013), 1671–1679, 10.1111/add.12235.
18. European Society of Cardiology (ESC), The Interactive Tool for Predicting and Managing the Risk of Heart Attack and Stroke. 2016 http://www.heartscore.org/Pages/welcome.aspx (Accessed 19 April 2016).
19. Farsalinos, K.E., Acute effects of using an electronic nicotine-delivery device (e-cigarette) on myocardial function: comparison with the effects of regular cigarettes. Munich ESC Congress, 2012.
20. Farsalinos, K.E., et al. Nicotine absorption from electronic cigarette use: comparison between first and new-generation devices. Sci. Rep., 4, 2014, 4133, 10.1038/srep04133.
21. Farsalinos, K.E., et al. Evaluation of electronic cigarette liquids and aerosol for the presence of selected inhalation toxins. Nicotine Tob. Res. 17 (2015), 168–174, 10.1093/ntr/ntu176.
22. Farsalinos, K.E., et al. Nicotine absorption from electronic cigarette use: comparison between experienced consumers (vapers) and naive users (smokers). Sci. Rep., 5, 2015, 11269, 10.1038/srep11269.
23. Farsalinos, K., et al. Effect of continuous smoking reduction and abstinence on blood pressure and heart rate in smokers switching to electronic cigarettes. Intern Emerg. Med. 11 (2016), 85–94, 10.1007/s11739-015-1361-y.
24. Flouris, A.D., et al. Acute effects of electronic and tobacco cigarette smoking on complete blood count. Food Chem. Toxicol. 50 (2012), 3600–3603, 10.1016/j.fct.2012.07.025.
25. Flouris, A.D., et al. Acute impact of active and passive electronic cigarette smoking on serum cotinine and lung function. Inhal. Toxicol. 25 (2013), 91–101, 10.3109/08958378.2012.758197.
26. Frost-Pineda, K., et al. Biomarkers of potential harm among adult smokers and nonsmokers in the total exposure study. Nicotine Tob. Res. 13 (2011), 182–193, 10.1093/ntr/ntq235.
27. Goniewicz, M.L., et al. Levels of selected carcinogens and toxicants in vapour from electronic cigarettes. Tob. Control 23 (2014), 133–139, 10.1136/tobaccocontrol-2012-050859.
28. Hajek, P., et al. Nicotine intake from electronic cigarettes on initial use and after 4 Weeks of regular use. Nicotine Tob. Res., 2014, 10.1093/ntr/ntu153.
29. Hecht, S.S., et al. Evaluation of toxicant and carcinogen metabolites in the urine of e-cigarette users versus cigarette smokers. Nicotine Tob. Res. 17 (2015), 704–709, 10.1093/ntr/ntu218.
30. Hughes, J.R., Measurement of the effects of abstinence from tobacco: a qualitative review. Psychol. Addict. Behav. 21 (2007), 127–137, 10.1037/0893-164X.21.2.127.
31. ICH, ICH Harmonised Tripartite Guideline ICH E1: the extent of population exposure to assess clinical safety for drugs intended for long-term treatment of non-life-threatening conditions. International Conference on Harmonisation, 1994.
32. Kapur, N.K., et al. High density lipoprotein cholesterol: an evolving target of therapy in the management of cardiovascular disease. Vasc. Health Risk Manag. 4 (2008), 39–57.
33. Kralikova, E., et al. Smoking cessation or reduction with nicotine replacement therapy: a placebo-controlled double blind trial with nicotine gum and inhaler. BMC Public Health, 9, 2009, 433, 10.1186/1471-2458-9-433.
34. Lauterbach, J.H., et al. Suggested Protocol for Estimation of Harmful and Potentially Harmful Constituents in Mainstream Aerosols Generated by Electronic Nicotine Delivery Systems (ENDS). 2012 (Poster).
35. Lowe, F.J., et al. Evaluation of biomarkers of exposure and potential harm in smokers, former smokers and never-smokers. Clin. Chem. Lab. Med. 47 (2009), 311–320, 10.1515/CCLM.2009.069.
36. Ludicke, F., et al. A Japanese cross-sectional multicentre study of biomarkers associated with cardiovascular disease in smokers and non-smokers. Biomarkers 20 (2015), 411–421, 10.3109/1354750X.2015.1096303.
37. Maeda, K., et al. The effects of cessation from cigarette smoking on the lipid and lipoprotein profiles: a meta-analysis. Prev. Med. 37 (2003), 283–290.
38. Manzoli, L., et al. Cohort study of electronic cigarette use: effectiveness and safety at 24 months. Tob. Control, 2016, 10.1136/tobaccocontrol-2015-052822.
39. McRobbie, H., et al. Effects of switching to electronic cigarettes with and without concurrent smoking on exposure to nicotine, carbon monoxide, and acrolein. Cancer Prev. Res. (Phila) 8 (2015), 873–878, 10.1158/1940-6207.CAPR-15-0058.
40. Miller, M.R., et al. Standardisation of spirometry. Eur. Respir. J. 26 (2005), 319–338, 10.1183/09031936.05.00034805.
41. Moyses, C., et al. Evaluation of a novel nicotine inhaler device: part 2-effect on craving and smoking urges. Nicotine Tob. Res. 17 (2015), 26–33, 10.1093/ntr/ntu122.
42. O'Connell, G., et al. Reductions in biomarkers of exposure (BoE) to harmful or potentially harmful constituents (HPHCs) following partial or complete substitution of cigarettes with electronic cigarettes in adult smokers. Toxicol. Mech. Methods 26 (2016), 443–454, 10.1080/15376516.2016.1196282.
43. Polosa, R., Electronic cigarette use and harm reversal: emerging evidence in the lung. BMC Med., 13, 2015, 54, 10.1186/s12916-015-0298-3.
44. Polosa, R., et al. Effect of an electronic nicotine delivery device (e-Cigarette) on smoking reduction and cessation: a prospective 6-month pilot study. BMC Public Health, 11, 2011, 786, 10.1186/1471-2458-11-786.
45. Polosa, R., et al. Effectiveness and tolerability of electronic cigarette in real-life: a 24-month prospective observational study. Intern Emerg. Med. 9 (2014), 537–546, 10.1007/s11739-013-0977-z.
46. Roche, Cobas b 221 Blood Gas Analyser System. Instructions for Use. Roche Reference Number 03261395001, 2009, Roche Diagnostics, Charles Avenue, Burgess Hill, West Sussex, UK.
47. Russo, C., et al. Evaluation of post cessation weight gain in a 1-year randomized smoking cessation trial of electronic cigarettes. Sci. Rep., 6, 2016, 18763, 10.1038/srep18763.
48. Tayyarah, R., Long, G.A., Comparison of select analytes in aerosol from e-cigarettes with smoke from conventional cigarettes and with ambient air. Regul. Toxicol. Pharmacol. 70 (2014), 704–710, 10.1016/j.yrtph.2014.10.010.
49. Theophilus, E.H., et al. Magnitudes of biomarker reductions in response to controlled reductions in cigarettes smoked per day: a one-week clinical confinement study. Regul. Toxicol. Pharmacol. 71 (2015), 225–234, 10.1016/j.yrtph.2014.12.023.
50. Tonnesen, P., et al. Efficacy of a nicotine mouth spray in smoking cessation: a randomised, double-blind trial. Eur. Respir. J. 40 (2012), 548–554, 10.1183/09031936.00155811.
51. van Staden, S.R., et al. Carboxyhaemoglobin levels, health and lifestyle perceptions in smokers converting from tobacco cigarettes to electronic cigarettes. S. Afr. Med. J. 103 (2013), 865–868, 10.7196/samj.6887.
52. Vansickel, A.R., et al. A clinical laboratory model for evaluating the acute effects of electronic “cigarettes”: nicotine delivery profile and cardiovascular and subjective effects. Cancer Epidemiol. Biomark. Prev. 19 (2010), 1945–1953, 10.1158/1055-9965.EPI-10-0288.
53. Vardavas, C.I., et al. Short-term pulmonary effects of using an electronic cigarette: impact on respiratory flow resistance, impedance, and exhaled nitric oxide. Chest 141 (2012), 1400–1406, 10.1378/chest.11-2443.
54. Walele, T., et al. A randomised, crossover study on an electronic vapour product, a nicotine inhalator and a conventional cigarette. Part A: pharmacokinetics. Regul. Toxicol. Pharmacol. 74 (2016), 187–192, 10.1016/j.yrtph.2015.12.003.
55. Walele, T., et al. A randomised, crossover study on an electronic vapour product, a nicotine inhalator and a conventional cigarette. Part B: safety and subjective effects. Regul. Toxicol. Pharmacol. 74 (2016), 193–199, 10.1016/j.yrtph.2015.12.004.
56. Zhu, S.H., et al. Four hundred and sixty brands of e-cigarettes and counting: implications for product regulation. Tob. Control 23:Suppl. 3 (2014), iii3–iii9, 10.1136/tobaccocontrol-2014-051670.