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.
Study Type
OBSERVATIONAL
Enrollment
1,050
Department of Medicine and Aging Sciences, University of Chieti
Chieti, CH, Italy
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.
Time frame: 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.
Time frame: 6, 12, 24, 36 and 60 months.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 5 years
Change from baseline in self-reported quality of life
Change in the average quality of life according to EuroQol EQ-D3.
Time frame: 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.
Time frame: 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.
Time frame: 5 years
Adherence to e-cigarette smoking
Number of months of continued e-cigarette smoking in groups EC and Mixed.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Adherence to e-cigarette smoking
Number of months of continued e-cigarette smoking in groups EC and Mixed.
Time frame: 3 years
Adherence to e-cigarette smoking
Number of months of continued e-cigarette smoking in groups EC and Mixed.
Time frame: 2 years
Adherence to e-cigarette smoking
Number of months of continued e-cigarette smoking in groups EC and Mixed.
Time frame: 1 year
Adherence to e-cigarette smoking
Number of months of continued e-cigarette smoking in groups EC and Mixed.
Time frame: 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.
Time frame: 1 year
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