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

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.

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 Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 1050

Contacts and Locations

Study Locations

• Italy
  • CH
    • Chieti, CH, Italy, 66100
      • Department of Medicine and Aging Sciences, University of Chieti

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult residents in the Abruzzo and Lazio Region of Italy that are smokers of traditional or electronic cigarettes

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
E-cigarettes only; Smokers of e-cigarettes containing nicotine only (non smoking traditional cigarettes and inhaling at least 50 puffs per week since six or more months). This group will be further split in the secondary analyses: never or former smokers of traditional cigarettes
Traditional cigarettes only; Smokers of traditional cigarettes only (smokers of at least one traditional cigarette per day since six or more months). This group will be further split in the secondary analyses: recent and older smokers.
Mixed group; Smokers of both electronic and traditional cigarettes (at least one per day since six or more months). This group will be further split in the secondary analyses: mixed smokers who quit and who did not quit traditional cigarette smoking during follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
Adherence to e-cigarette smoking	Number of months of continued e-cigarette smoking in groups EC and Mixed.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	6 months
Adherence to e-cigarette smoking	Number of months of continued e-cigarette smoking in groups EC and Mixed.	3 years
Adherence to e-cigarette smoking	Number of months of continued e-cigarette smoking in groups EC and Mixed.	2 years
Adherence to e-cigarette smoking	Number of months of continued e-cigarette smoking in groups EC and Mixed.	1 year
Adherence to e-cigarette smoking	Number of months of continued e-cigarette smoking in groups EC and Mixed.	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.	1 year

Collaborators and Investigators

• Sponsor: Università degli Studi 'G. d'Annunzio' Chieti e Pescara
• Collaborators: University of Roma La Sapienza; Catholic University of the Sacred Heart; University of Turin, Italy; University of Catania; Mario Negri Institute for Pharmacological Research
• Investigators: Principal Investigator: Lamberto Manzoli, MD, MPH, Department of Medicine and Aging Sciences, University of Chieti, Italy

Publications and helpful links

General Publications

• 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.
• 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;10(6):e0129443. doi: 10.1371/journal.pone.0129443. eCollection 2015.
• 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: 10.1136/tobaccocontrol-2015-052822. Epub 2016 Jun 6.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: February 1, 2013
• First Submitted That Met QC Criteria: February 6, 2013
• First Posted (Estimate): February 7, 2013

Study Record Updates

• Last Update Posted (Actual): May 5, 2017
• Last Update Submitted That Met QC Criteria: May 2, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: safety; cardiovascular disease; efficacy; observational study; hospitalization; cigarette smoking; e-cigarette smoking; chronic obstructive pulmonary diseases
• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Cardiovascular Diseases; Stomach Neoplasms; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Lung Neoplasms; Urinary Bladder Neoplasms
• Other Study ID Numbers: CHLM001