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

• Conditions: Cancer of the Stomach; Cardiovascular Diseases; Cancer of the Lung; Cancer of the Bladder; Chronic Obstructive Pulmonary Diseases

• Registration Number: NCT01785537
• Lead Sponsor: Università degli Studi 'G. d'Annunzio' Chieti e Pescara

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-02-01
• Study First Submitted QC: 2013-02-06
• Study First Posted: 2013-02-07
• Study Start: 2013-10
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-05
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1050

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
Rate of subjects with smoking-related hospitalizations	2 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.
Number of smoking-related hospitalizations	1 year	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.
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.
Number of Participants with Adverse Events as a Measure of Safety and tolerability	6 months	Self-reported side effects as measured by VAS and a structured report form.
Time to hospitalization for cardiovascular diseases, COPD and smoking-related cancer.	2 years	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.
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.
Adherence to e-cigarette smoking	6 months	Number of months of continued e-cigarette smoking in groups EC and Mixed.
Smoking abstinence	6 months	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.

Trial Locations

Locations (1)

Department of Medicine and Aging Sciences, University of Chieti; 🇮🇹 Chieti, CH, Italy