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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiovascular Diseases
- Sponsor
- Università degli Studi 'G. d'Annunzio' Chieti e Pescara
- Enrollment
- 1050
- Locations
- 1
- Primary Endpoint
- Change from baseline in the number of traditional cigarette smoked
- Last Updated
- 8 years ago
Overview
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.
Investigators
Lamberto Manzoli
Associate Professor of Epidemiology and Public Health
Università degli Studi 'G. d'Annunzio' Chieti e Pescara
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Change from baseline in the number of traditional cigarette smoked
Time Frame: 6, 12, 24, 36 and 60 months.
Change in the average self-reported number of traditional cigarette smoked per day.
Traditional smoking cessation rate
Time Frame: 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.
Secondary Outcomes
- Rate of subjects with smoking-related hospitalizations(2 years)
- Number of smoking-related hospitalizations(1 year)
- Number of hospitalizations for cardiovascular diseases(5 years)
- Number of hospitalizations for smoking-related cancers(5 years)
- Change from baseline in self-reported quality of life(6, 12, 24 and 36 months)
- Number of Participants with Adverse Events as a Measure of Safety and tolerability(6 months)
- Time to hospitalization for cardiovascular diseases, COPD and smoking-related cancer.(2 years)
- Traditional and electronic smoking (overall smoking) cessation(1 year)
- Adherence to e-cigarette smoking(6 months)
- Smoking abstinence(6 months)