Davide Campagna

EffiCiency and Safety of an eLectronic cigAreTte (ECLAT) as Tobacco Cigarettes Substitute: A Prospective 12-Month Randomized Control Design Study

Background Electronic cigarettes (e-cigarettes) are becoming increasingly popular with smokers worldwide. Users report buying them to help quit smoking, to reduce cigarette consumption, to relieve tobacco withdrawal symptoms, and to continue having a ‘smoking’ experience, but with reduced health risks. Research on e-cigarettes is urgently needed in order to ensure that the decisions of regulators, healthcare providers and consumers are based on science. Methods ECLAT is a prospective 12-month randomized, controlled trial that evaluates smoking reduction/abstinence in 300 smokers not intending to quit experimenting two different nicotine strengths of a popular e-cigarette model (‘Categoria’; Arbi Group Srl, Italy) compared to its non-nicotine choice. GroupA (nu200a=u200a100) received 7.2 mg nicotine cartridges for 12 weeks; GroupB (nu200a=u200a100), a 6-week 7.2 mg nicotine cartridges followed by a further 6-week 5.4 mg nicotine cartridges; GroupC (nu200a=u200a100) received no-nicotine cartridges for 12 weeks. The study consisted of nine visits during which cig/day use and exhaled carbon monoxide (eCO) levels were measured. Smoking reduction and abstinence rates were calculated. Adverse events and product preferences were also reviewed. Results Declines in cig/day use and eCO levels were observed at each study visits in all three study groups (p<0.001 vs baseline), with no consistent differences among study groups. Smoking reduction was documented in 22.3% and 10.3% at week-12 and week-52 respectively. Complete abstinence from tobacco smoking was documented in 10.7% and 8.7% at week-12 and week-52 respectively. A substantial decrease in adverse events from baseline was observed and withdrawal symptoms were infrequently reported during the study. Participants’ perception and acceptance of the product under investigation was satisfactory. Conclusion In smokers not intending to quit, the use of e-cigarettes, with or without nicotine, decreased cigarette consumption and elicited enduring tobacco abstinence without causing significant side effects. Trial Registration ClinicalTrials.gov NCT01164072 NCT01164072

Effect of an electronic nicotine delivery device ( e -Cigarette) on smoking reduction and cessation: a prospective 6-month pilot study

BackgroundCigarette smoking is a tough addiction to break. Therefore, improved approaches to smoking cessation are necessary. The electronic-cigarette (e-Cigarette), a battery-powered electronic nicotine delivery device (ENDD) resembling a cigarette, may help smokers to remain abstinent during their quit attempt or to reduce cigarette consumption. Efficacy and safety of these devices in long-term smoking cessation and/or smoking reduction studies have never been investigated.MethodsIn this prospective proof-of-concept study we monitored possible modifications in smoking habits of 40 regular smokers (unwilling to quit) experimenting the Categoria e-Cigarette with a focus on smoking reduction and smoking abstinence. Study participants were invited to attend a total of five study visits: at baseline, week-4, week-8, week-12 and week-24. Product use, number of cigarettes smoked, and exhaled carbon monoxide (eCO) levels were measured at each visit. Smoking reduction and abstinence rates were calculated. Adverse events and product preferences were also reviewed.ResultsSustained 50% reduction in the number of cig/day at week-24 was shown in 13/40(32.5%) participants; their median of 25 cigs/day decreasing to 6 cigs/day (p < 0.001). Sustained 80% reduction was shown in 5/40(12.5%) participants; their median of 30 cigs/day decreasing to 3 cigs/day (p = 0.043). Sustained smoking abstinence at week-24 was observed in 9/40(22.5%) participants, with 6/9 still using the e-Cigarette by the end of the study. Combined sustained 50% reduction and smoking abstinence was shown in 22/40 (55%) participants, with an overall 88% fall in cigs/day. Mouth (20.6%) and throat (32.4%) irritation, and dry cough (32.4%) were common, but diminished substantially by week-24. Overall, 2 to 3 cartridges/day were used throughout the study. Participants perception and acceptance of the product was good.ConclusionThe use of e-Cigarette substantially decreased cigarette consumption without causing significant side effects in smokers not intending to quit (http://ClinicalTrials.gov number NCT01195597).

Effectiveness and tolerability of electronic cigarette in real-life: a 24-month prospective observational study

Electronic cigarettes (e-Cigarette) are battery-operated devices designed to vaporise nicotine that may aid smokers to quit or reduce their cigarette consumption. Research on e-Cigarettes is urgently needed to ensure that the decisions of regulators, healthcare providers and consumers are evidence based. Here we assessed long-term effectiveness and tolerability of e-Cigarette used in a ‘naturalistic’ setting. This prospective observational study evaluated smoking reduction/abstinence in smokers not intending to quit using an e-Cigarette (‘Categoria’; Arbi Group, Italy). After an intervention phase of 6xa0months, during which e-Cigarette use was provided on a regular basis, cigarettes per day (cig/day) and exhaled carbon monoxide (eCO) levels were followed up in an observation phase at 18 and 24xa0months. Efficacy measures included: (a) ≥50xa0% reduction in the number of cig/day from baseline, defined as self-reported reduction in the number of cig/day (≥50xa0%) compared to baseline; (b) ≥80xa0% reduction in the number of cig/day from baseline, defined as self-reported reduction in the number of cig/day (≥80xa0%) compared to baseline; (c) abstinence from smoking, defined as complete self-reported abstinence from tobacco smoking (together with an eCO concentration of ≤10xa0ppm). Smoking reduction and abstinence rates were computed, and adverse events reviewed. Of the 40 subjects, 17 were lost to follow-up at 24xa0months. A >50xa0% reduction in the number of cig/day at 24xa0months was shown in 11/40 (27.5xa0%) participants with a median of 24xa0cig/day use at baseline decreasing significantly to 4xa0cig/day (pxa0=xa00.003). Smoking abstinence was reported in 5/40 (12.5xa0%) participants while combined >50xa0% reduction and smoking abstinence was observed in 16/40 (40xa0%) participants at 24xa0months. Five subjects stopped e-Cigarette use (and stayed quit), three relapsed back to tobacco smoking and four upgraded to more performing products by 24xa0months. Only some mouth irritation, throat irritation, and dry cough were reported. Withdrawal symptoms were uncommon. Long-term e-Cigarette use can substantially decrease cigarette consumption in smokers not willing to quit and is well tolerated. (http://ClinicalTrials.govnumberNCT01195597).

The emerging phenomenon of electronic cigarettes

The need for novel and more effective approaches to tobacco control is unquestionable. The electronic cigarette is a battery-powered electronic nicotine delivery system that looks very similar to a conventional cigarette and is capable of emulating smoking, but without the combustion products accountable for smoking’s damaging effects. Smokers who decide to switch to electronic cigarettes instead of continuing to smoke would achieve large health gains. The electronic cigarette is an emerging phenomenon that is becoming increasingly popular with smokers worldwide. Users report buying them to help quit smoking, to reduce cigarette consumption, to relieve tobacco withdrawal symptoms due to workplace smoking restrictions and to continue to have a ‘smoking’ experience but with reduced health risks. The focus of the present article is the health effects of using electronic cigarettes, with consideration given to the acceptability, safety and effectiveness of this product to serve as a long-term substitute for smoking or as a tool for smoking cessation.

Successful smoking cessation with electronic cigarettes in smokers with a documented history of recurring relapses: a case series.

IntroductionSmoking cessation programs are useful in helping smokers to quit, but smoking is a very difficult addiction to break and the need for novel and effective approaches to smoking cessation interventions is unquestionable. The E-cigarette is a battery-powered electronic nicotine delivery device that may help smokers to remain abstinent during their quit attempt. We report for the first time objective measures of smoking cessation in smokers who experimented with the E-cigarette.Case presentationThree Caucasian smokers (two men aged 47 and 65 years and one woman aged 38 years) with a documented history of recurring relapses were able to quit and to remain abstinent for at least six months after taking up an E-cigarette.ConclusionsThis is the first time that objective measures of smoking cessation are reported for smokers who quit successfully after using an E-cigarette. This was accomplished in smokers who repeatedly failed in previous attempts with professional smoking cessation assistance using the usual nicotine dependence treatments and smoking cessation counselling.

Effect of a nicotine-free inhalator as part of a smoking-cessation programme

Smoking-cessation drugs are inadequate at addressing the behavioural component of tobacco dependence. Nicotine-free inhalators are plastic devices that may provide a coping mechanism for conditioned smoking by replacing some of the rituals associated with smoking gestures. This study assessed the effect of using a nicotine-free inhalator to improve success in a cessation programme. At baseline, 120 smokers attending a smoking-cessation programme were assessed for their sociodemographic factors, smoking history, depression, physical and behavioural dependence, and motivation. Participants were randomly assigned to two groups, nicotine-free inhalator group (PAIPO; Echos Srl, Milan, Italy) versus reference group. For the whole sample, no significant difference was found in quit rates at 24 weeks between the PAIPO group and the reference group. However, the quit rate in the PAIPO group (66.7%) was more than three-fold higher than the reference group (19.2%) for those individuals with high Glover–Nilsson Smoking Behavioural Questionnaire (GN-SBQ) scores at baseline. The results of the logistic model analysis indicate that a high GN-SBQ score is a strong independent predictor for successful quitting at 24 weeks (OR 8.88; 95% CI 2.08–37.94) in the PAIPO group. Nicotine-free inhalators may be beneficial when used in the context of smoking-cessation interventions, particularly for those smokers for whom handling and manipulation of their cigarettes plays an important part in the ritual of smoking.

Effect of continuous smoking reduction and abstinence on blood pressure and heart rate in smokers switching to electronic cigarettes

AbstractWe present prospective blood pressure (BP) and hear rate (HR) changes in smokers ninvited to switch to e-cigarettes in the ECLAT study. BP and HR changes were compared among (1) different study groups (users of high, low, and zero nicotine products) and (2) pooled continuous smoking phenotype classification (same phenotype from week 12 to -52), with participants classified as quitters (completely quit smoking), reducers (≥50xa0% reduction in smoking consumption) and failures (<50xa0% or no reduction in smoking consumption). Additionally, the latter comparison was repeated in a subgroup of participants with elevated BP at baseline. No significant changes were observed among study groups for systolic BP, diastolic BP, and HR. In 145 subjects with a continuous smoking phenotype, we observed lower systolic BP at week 52 compared to baseline but no effect of smoking phenotype classification. When the same analysis was repeated in 66 subjects with elevated BP at baseline, a substantial reduction in systolic BP was observed at week 52 compared to baseline (132.4xa0±xa012.0 vs. 141.2xa0±xa010.5xa0mmHg, pxa0<xa00.001), with a significant effect found for smoking phenotype classification. After adjusting for weight change, gender and age, reduction in systolic BP from baseline at week 52 remains associated significantly with both smoking reduction and smoking abstinence. In conclusion, smokers who reduce or quit smoking by switching to e-cigarettes may lower their systolic BP in the long term, and this reduction is apparent in smokers with elevated BP. The current study adds to the evidence that quitting smoking with the use of e-cigarettes does not lead to higher BP values, and this is independently observed whether e-cigarettes are regularly used or not.

Changes in breathomics from a 1‐year randomized smoking cessation trial of electronic cigarettes

Electronic cigarette (EC) use is an emerging behaviour that has been shown to help smokers to reduce cigarette consumption. The aim of this study was to illustrate long‐term changes in exhaled breath measurements and respiratory symptoms in smokers invited to quit or reduce their cigarette consumption by switching to ECs.

Lung function and respiratory symptoms in a randomized smoking cessation trial of electronic cigarettes

Quitting smoking is the most important step smokers can take to improve their health. Nonetheless, there is little information on long-term improvements in lung function and/or respiratory symptoms after smoking cessation. Here we illustrate long-term changes in spirometric indices as well as in respiratory symptoms in smokers invited to quit or reduce their cigarette consumption by switching to electronic cigarettes (ECs). Prospective evaluation of cigarette consumption, spirometry and symptoms was performed in a 1-year randomized controlled trial of smokers receiving EC containing 2.4%, 1.8% or 0% nicotine. Spirometric data are presented on the basis of participants pooled continuous smoking phenotype classification (Quitters, Reducers, Failures), whereas respiratory symptoms on the basis of their point prevalence-smoking phenotype. Smoking phenotype classification (Quitters, Reducers, Failures) had no significant effect on spirometric indices (FEV1, FVC and FEV1/FVC) with the exception of FEF25-75%, which significantly (Pu2009u2009=0.034) increased over the time among Quitters; their FEF25-75% (% predicted) improving from (means±S.D.) 85.7±15.6% at baseline (BL) to 100.8±14.6%. High prevalence of cough/phlegm (43.1%) and shortness of breath (SoB; 34.8%) was reported at BL with substantial reduction in their frequency at subsequent follow-up visits. These symptoms virtually disappeared very quickly in both quitters and reducers. Smokers invited to switch to ECs who completely abstained from smoking showed steady progressive improvements in their FEF25-75% Normalization of peripheral airways function was associated with improvement in respiratory symptoms, adding to the notion that abstaining from smoking can reverse tobacco harm in the lung.

Impact of air quality on lung health: myth or reality?

The respiratory system is a primary target of the harmful effects of key air pollutants of health concern. Several air pollutants have been implicated including particulate matter (PM), ozone (O3), nitrogen dioxide (NO2) polycyclic aromatic hydrocarbons (PAHs) and volatile organic compounds (VOCs). It is well known that episodes of exposure to high concentrations of outdoor air pollutants can cause acute respiratory exacerbations. However, there is now increasing evidence suggesting that significant exposure to outdoor air pollutants may be also associated with development of lung cancer and with incident cases of chronic obstructive pulmonary disease (COPD) and respiratory allergies. Here we provide a critical appraisal of the impact of air pollution on respiratory diseases and discuss strategies for preventing excessive exposure to harmful air pollutants. However, the evidence that significant exposure to air pollutants is causing COPD, lung cancer or respiratory allergies is not conclusive and therefore regulators must be aware that execution of clean air policies may not be that cost-effective and may lead to unintended consequences. Addressing the lung health effects of air pollution must be considered work in progress.