The Efficacy and Safety of Electronic Cigarettes: a 5-year Follow-up Study

Study Overview
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Brief Summary
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The main aim of this multicentric 5-year follow-up study is to evaluate for the first time the long-term efficacy and safety (in terms of smoking-related serious diseases requiring hospitalization) of e-cigarette smoking, comparing its health effects with those of traditional cigarette smoking and mixed electronic and traditional cigarette smoking. The study will also permit to evaluate, over a 5-year follow-up, the self-reported quality of life, and the reported adverse events according to current and past smoking habit. Finally, the study will also explore the long-term adherence to e-cigarette smoking and its efficacy of e-cigarettes in reducing and/or quitting traditional cigarette smoking.

Official Title
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Multicentric 5-year Follow-up Study to Assess the Efficacy of E-cigarettes as a Tool for Smoking Cessation and to Compare the Risk of Smoking-related Diseases Among Electronic and Traditional Cigarette Smokers, and Smokers of Both.

Conditions
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Cardiovascular Diseases, Chronic Obstructive Pulmonary Diseases, Cancer of the Lung, Cancer of the Bladder, Cancer of the Stomach

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: resident into the Abruzzo and Lazio Region aged between 30 and 75 years; smoker of e-cigarettes (inhaling at least 50 puffs per week) containing nicotine since six or more months (E-cigarettes only Group); smoker of at least one traditional cigarette per day since six or more months (Traditional cigarettes only Group); smoker of both electronic and traditional cigarettes (at least one per day) since six or more months (Mixed Group). Exclusion Criteria: illicit drug use, breastfeeding or pregnancy, major depression or other psychiatric conditions, severe allergies, active antihypertensive medication, angina pectoris, past episodes of major cardiovascular diseases (myocardial infarction, stroke/TIA, congestive heart failure, COPD, cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| E-cigarettes only<br>Smokers of e-cigarettes containing nicotine only (non smoking traditional cigarettes and inhaling at least 50 puffs per week since six or more months). This group will be further split in the secondary analyses: never or former smokers of traditional cigarettes | |
| Traditional cigarettes only<br>Smokers of traditional cigarettes only (smokers of at least one traditional cigarette per day since six or more months). This group will be further split in the secondary analyses: recent and older smokers. | |
| Mixed group<br>Smokers of both electronic and traditional cigarettes (at least one per day since six or more months). This group will be further split in the secondary analyses: mixed smokers who quit and who did not quit traditional cigarette smoking during follow-up | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Traditional smoking cessation rate | Percentage of subjects that were current (in TC and Mixed groups) or former (in EC group) smokers reporting sustained smoking abstinence from traditional cigarette smoking at 60 months. Smoking abstinence is defined as complete abstinence from tobacco smoking (not even a puff) for the 30 days period prior to the visit. This outcome will be self-reported and checked using CO analyzer after breath. | 5 years | 
| Change from baseline in the number of traditional cigarette smoked | Change in the average self-reported number of traditional cigarette smoked per day. | 6, 12, 24, 36 and 60 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of subjects with smoking-related hospitalizations | Percentage of subjects who had a hospital admission for one of the followings: cardiovascular diseases, chronic obstructive pulmonary diseases, cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia. Repeated admissions of the same subject will be counted once. | 5 years | 
| Number of smoking-related hospitalizations | Mean number of hospital admissions for one of the followings: cardiovascular diseases, chronic obstructive pulmonary diseases, cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia. Each admissions of the same subject will be counted. | 5 years | 
| Number of hospitalizations for cardiovascular diseases | Mean number of hospital admissions for cardiovascular diseases. Each admissions of the same subject will be counted. | 5 years | 
| Number of hospitalizations for smoking-related cancers | Mean number of hospital admissions for cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia. Each admissions of the same subject will be counted. | 5 years | 
| Change from baseline in self-reported quality of life | Change in the average quality of life according to EuroQol EQ-D3. | 6, 12, 24 and 36 months | 
| Time to hospitalization for cardiovascular diseases, COPD and smoking-related cancer. | Time to hospital admission for one of the followings: cardiovascular diseases, chronic obstructive pulmonary diseases, cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia. Repeated admissions of the same subject will be counted once and the subject will be censored at the date of the first admission. | 5 year | 
| Number of Participants with Adverse Events as a Measure of Safety and tolerability | Self-reported side effects as measured by VAS and a structured report form. | 5 years | 
| Adherence to e-cigarette smoking | Number of months of continued e-cigarette smoking in groups EC and Mixed. | 5 years | 
| Time to hospitalization for cardiovascular diseases, COPD and smoking-related cancer. | The primary outcome measure is time to hospital admission for one of the followings: cardiovascular diseases, chronic obstructive pulmonary diseases, cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia. Repeated admissions of the same subject will be counted once and the subject will be censored at the date of the first admission. | 3 years | 
| Time to hospitalization for cardiovascular diseases, COPD and smoking-related cancer. | The primary outcome measure is time to hospital admission for one of the followings: cardiovascular diseases, chronic obstructive pulmonary diseases, cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia. Repeated admissions of the same subject will be counted once and the subject will be censored at the date of the first admission. | 2 years | 
| Rate of subjects with smoking-related hospitalizations | Percentage of subjects who had a hospital admission for one of the followings: cardiovascular diseases, chronic obstructive pulmonary diseases, cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia. Repeated admissions of the same subject will be counted once. | 3 years | 
| Rate of subjects with smoking-related hospitalizations | Percentage of subjects who had a hospital admission for one of the followings: cardiovascular diseases, chronic obstructive pulmonary diseases, cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia. Repeated admissions of the same subject will be counted once. | 2 years | 
| Number of smoking-related hospitalizations | Mean number of hospital admissions for one of the followings: cardiovascular diseases, chronic obstructive pulmonary diseases, cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia. Each admissions of the same subject will be counted. | 2 years | 
| Number of smoking-related hospitalizations | Mean number of hospital admissions for one of the followings: cardiovascular diseases, chronic obstructive pulmonary diseases, cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia. Each admissions of the same subject will be counted. | 1 year | 
| Smoking abstinence | Percentage of subjects reporting sustained smoking abstinence from traditional cigarette smoking. Smoking abstinence is defined as complete abstinence from tobacco smoking (not even a puff) for the 30 days period prior to the visit. | 3 years | 
| Smoking abstinence | Percentage of subjects reporting sustained smoking abstinence from traditional cigarette smoking. Smoking abstinence is defined as complete abstinence from tobacco smoking (not even a puff) for the 30 days period prior to the visit. | 2 years | 
| Smoking abstinence | Percentage of subjects reporting sustained smoking abstinence from traditional cigarette smoking. Smoking abstinence is defined as complete abstinence from tobacco smoking (not even a puff) for the 30 days period prior to the visit. | 1 year | 
| Smoking abstinence | Percentage of subjects reporting sustained smoking abstinence from traditional cigarette smoking. Smoking abstinence is defined as complete abstinence from tobacco smoking (not even a puff) for the 30 days period prior to the visit. | 6 months | 
| Number of Participants with Adverse Events as a Measure of Safety and tolerability | Self-reported side effects as measured by VAS and a structured report form. | 3 years | 
| Number of Participants with Adverse Events as a Measure of Safety and tolerability | Self-reported side effects as measured by VAS and a structured report form. | 2 years | 
| Number of Participants with Adverse Events as a Measure of Safety and tolerability | Self-reported side effects as measured by VAS and a structured report form. | 1 year | 
| Number of Participants with Adverse Events as a Measure of Safety and tolerability | Self-reported side effects as measured by VAS and a structured report form. | 6 months | 
| Adherence to e-cigarette smoking | Number of months of continued e-cigarette smoking in groups EC and Mixed. | 3 years | 
| Adherence to e-cigarette smoking | Number of months of continued e-cigarette smoking in groups EC and Mixed. | 2 years | 
| Adherence to e-cigarette smoking | Number of months of continued e-cigarette smoking in groups EC and Mixed. | 1 year | 
| Adherence to e-cigarette smoking | Number of months of continued e-cigarette smoking in groups EC and Mixed. | 6 months | 
| Traditional and electronic smoking (overall smoking) cessation | Percentage of subjects in all groups reporting sustained smoking abstinence from both traditional and electronic cigarette smoking at 12 months. Smoking abstinence is defined as complete abstinence from tobacco or electronic smoking (not even a puff) for the 30 days period prior to the visit. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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e-cigarette smoking, cigarette smoking, cardiovascular disease, chronic obstructive pulmonary diseases, observational study, efficacy, safety, hospitalization