title: A randomised, parallel group study to evaluate the safety profile of an electronic vapour product over 12 weeks.
abstract: A randomised, parallel group clinical study was performed to evaluate the safety profile of an e-vapour product (EVP; 2.0% nicotine) in smokers of conventional cigarettes (CCs) switching to use the EVP for 12 weeks. During the study, no clinically significant product-related findings were observed in terms of vital signs, electrocardiogram, lung function tests and standard clinical laboratory parameters. Adverse events (AEs) reported by EVP subjects were more frequent during the first week after switching to the EVP. The frequency of AEs reduced thereafter and out of a total of 1515 reported AEs, 495 were judged as being related to nicotine withdrawal symptoms. The most frequently stated AEs were headache, sore throat, desire to smoke and cough reported by 47.4, 27.8, 27.5 and 17.0% of subjects, respectively. Only 6% of AEs were judged as probably or definitely related to the EVP. Additional observations in EVP subjects included a decrease in the level of urine nicotine equivalents by up to 33.8%, and decreases in the level of three biomarkers of exposure to toxicants known to be present in CC smoke (benzene, acrolein and 4-[methylnitrosamino]-1-[3-pyridyl]-1-butanone). The decrease in nicotine equivalents coincided with an increase in nicotine withdrawal symptoms, measured by a questionnaire, which subsided after two weeks. The data presented here shows the potential EVPs may offer smokers looking for an alternative to CCs.
authors: Fontem Ventures, Barbara Strozzilaan 101, 1083 HN, Amsterdam, Netherlands. Electronic address: AnaMaria.Cravo@fontemventures.com.
authors: Ana S
authors: AS
authors: Cravo
authors: Covance Clinical Research Unit, Hyde Street, Leeds, LS2 9LH, UK.
authors: Jim
authors: J
authors: Bush
authors: Simbec Research, Merthyr Tydfil, CF48 4DR, UK.
authors: Girish
authors: G
authors: Sharma
authors: Clinopsis S.A., Jardins 6, 1426, Concise, Switzerland.
authors: Rebecca
authors: R
authors: Savioz
authors: Clinopsis S.A., Jardins 6, 1426, Concise, Switzerland.
authors: Claire
authors: C
authors: Martin
authors: Fontem Ventures, Barbara Strozzilaan 101, 1083 HN, Amsterdam, Netherlands.
authors: Simon
authors: S
authors: Craige
authors: Fontem Ventures, Barbara Strozzilaan 101, 1083 HN, Amsterdam, Netherlands.
authors: Tanvir
authors: T
authors: Walele
mesh_terms: D000280:Administration, Inhalation; D000328:Adult; D015415:Biomarkers / Q000097:blood / Q000652:urine; D003257:Consumer Product Safety; D066300:Electronic Nicotine Delivery Systems / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009538:Nicotine / Q000008:administration & dosage* / Q000009:adverse effects; D018722:Nicotinic Agonists / Q000008:administration & dosage* / Q000009:adverse effects; D018570:Risk Assessment; D012907:Smoking / Q000009:adverse effects / Q000097:blood / Q000652:urine; D016540:Smoking Cessation / Q000379:methods*; D000074606:Smoking Prevention; D013375:Substance Withdrawal Syndrome / Q000209:etiology; D011795:Surveys and Questionnaires; D013997:Time Factors; D014029:Tobacco Use Disorder / Q000628:therapy*; D006113:United Kingdom; D014835:Volatilization; D055815:Young Adult
chemical_list: D015415:Biomarkers; D018722:Nicotinic Agonists; D009538:Nicotine
keywords: Adverse events; Biomarkers of biological effect; Biomarkers of exposure; Cigarette; Clinical study; Electronic cigarette; Electronic vapour product; Safety; Smoking urges; Withdrawal symptoms