Cancer of the Bladder, Cancer of the Lung, Cancer of the Stomach, Cardiovascular Diseases, Chronic Obstructive Pulmonary Diseases
Conditions
Keywords
e-cigarette smoking, cigarette smoking, cardiovascular disease, hospitalization, chronic obstructive pulmonary diseases, observational study, efficacy, safety
Brief summary
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.
Interventions
None listed
Sponsors
University of Roma La Sapienza
Catholic University of the Sacred Heart
University of Turin, Italy
University of Catania
Mario Negri Institute for Pharmacological Research
Università degli Studi 'G. d'Annunzio' Chieti e Pescara
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Traditional smoking cessation rate | 5 years | 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. |
| Change from baseline in the number of traditional cigarette smoked | 6, 12, 24, 36 and 60 months. | Change in the average self-reported number of traditional cigarette smoked per day. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of hospitalizations for cardiovascular diseases | 5 years | Mean number of hospital admissions for cardiovascular diseases. Each admissions of the same subject will be counted. |
| Number of hospitalizations for smoking-related cancers | 5 years | 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. |
| Change from baseline in self-reported quality of life | 6, 12, 24 and 36 months | Change in the average quality of life according to EuroQol EQ-D3. |
| Time to hospitalization for cardiovascular diseases, COPD and smoking-related cancer. | 5 year | 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. |
| Rate of subjects with smoking-related hospitalizations | 5 years | 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. |
| Adherence to e-cigarette smoking | 5 years | Number of months of continued e-cigarette smoking in groups EC and Mixed. |
| Smoking abstinence | 3 years | 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. |
| Traditional and electronic smoking (overall smoking) cessation | 1 year | 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. |
| Number of Participants with Adverse Events as a Measure of Safety and tolerability | 5 years | Self-reported side effects as measured by VAS and a structured report form. |
| Number of smoking-related hospitalizations | 5 years | 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. |
Countries
Italy
Outcome results
None listed