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

Cardiovascular Diseases Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01785537
• Other study ID #: CHLM001
• Status: Active, not recruiting
• Phase: N/A
• First received: February 1, 2013
• Last updated: May 2, 2017
• Start date: October 2013
• Est. completion date: December 2019

Study information

• Verified date: May 2017
• Source: Università degli Studi 'G. d'Annunzio' Chieti e Pescara
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1050
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer of the Bladder
• Cancer of the Lung
• Cancer of the Stomach
• Cardiovascular Diseases
• Chronic Obstructive Pulmonary Diseases
• Lung Diseases
• Lung Diseases, Obstructive
• Lung Neoplasms
• Pulmonary Disease, Chronic Obstructive
• Stomach Neoplasms
• Urinary Bladder Neoplasms

Locations

Country	Name	City	State
Italy	Department of Medicine and Aging Sciences, University of Chieti	Chieti	CH

Sponsors (6)

Lead Sponsor	Collaborator
Università degli Studi 'G. d'Annunzio' Chieti e Pescara	Catholic University of the Sacred Heart, Mario Negri Institute for Pharmacological Research, University of Catania, University of Roma La Sapienza, University of Turin, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Manzoli L, Flacco ME, Ferrante M, La Vecchia C, Siliquini R, Ricciardi W, Marzuillo C, Villari P, Fiore M; ISLESE Working Group.. Cohort study of electronic cigarette use: effectiveness and safety at 24 months. Tob Control. 2017 May;26(3):284-292. doi: 10 — View Citation

Manzoli L, Flacco ME, Fiore M, La Vecchia C, Marzuillo C, Gualano MR, Liguori G, Cicolini G, Capasso L, D'Amario C, Boccia S, Siliquini R, Ricciardi W, Villari P. Electronic Cigarettes Efficacy and Safety at 12 Months: Cohort Study. PLoS One. 2015 Jun 10; — View Citation

Manzoli L, La Vecchia C, Flacco ME, Capasso L, Simonetti V, Boccia S, Di Baldassarre A, Villari P, Mezzetti A, Cicolini G. Multicentric cohort study on the long-term efficacy and safety of electronic cigarettes: study design and methodology. BMC Public Health. 2013 Sep 24;13:883. doi: 10.1186/1471-2458-13-883. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Adherence to e-cigarette smoking	Number of months of continued e-cigarette smoking in groups EC and Mixed.	5 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Adherence to e-cigarette smoking	Number of months of continued e-cigarette smoking in groups EC and Mixed.	3 years
Secondary	Adherence to e-cigarette smoking	Number of months of continued e-cigarette smoking in groups EC and Mixed.	2 years
Secondary	Adherence to e-cigarette smoking	Number of months of continued e-cigarette smoking in groups EC and Mixed.	1 year
Secondary	Adherence to e-cigarette smoking	Number of months of continued e-cigarette smoking in groups EC and Mixed.	6 months
Secondary	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