Clinical trial NCT01785537: The Efficacy and Safety of Electronic Cigarettes: a 5-year Follow-up Study
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Diseases
Chronic Obstructive Pulmonary Diseases
Cancer of the Lung
Cancer of the Bladder
Cancer of the Stomach
Keywords: e-cigarette smoking
cigarette smoking
cardiovascular disease
hospitalization
chronic obstructive pulmonary diseases
observational study
efficacy
safety
Lead sponsor: Università degli Studi 'G. d'Annunzio' Chieti e Pescara
Sponsor class: OTHER
Collaborators: name: University of Roma La Sapienza
name: Catholic University of the Sacred Heart
name: University of Turin, Italy
name: University of Catania
name: Mario Negri Institute for Pharmacological Research
First posted: 2013-02-07
Enrollment: 1050
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


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.

Primary outcomes:
measure: Traditional smoking cessation rate
timeFrame: 5 years
measure: Change from baseline in the number of traditional cigarette smoked
timeFrame: 6, 12, 24, 36 and 60 months.
Secondary outcomes:
measure: Rate of subjects with smoking-related hospitalizations
timeFrame: 5 years
measure: Number of smoking-related hospitalizations
timeFrame: 5 years
measure: Number of hospitalizations for cardiovascular diseases
timeFrame: 5 years
measure: Number of hospitalizations for smoking-related cancers
timeFrame: 5 years
measure: Change from baseline in self-reported quality of life
timeFrame: 6, 12, 24 and 36 months
measure: Time to hospitalization for cardiovascular diseases, COPD and smoking-related cancer.
timeFrame: 5 year
measure: Number of Participants with Adverse Events as a Measure of Safety and tolerability
timeFrame: 5 years
measure: Adherence to e-cigarette smoking
timeFrame: 5 years
measure: Time to hospitalization for cardiovascular diseases, COPD and smoking-related cancer.
timeFrame: 3 years
measure: Time to hospitalization for cardiovascular diseases, COPD and smoking-related cancer.
timeFrame: 2 years
measure: Rate of subjects with smoking-related hospitalizations
timeFrame: 3 years
measure: Rate of subjects with smoking-related hospitalizations
timeFrame: 2 years
measure: Number of smoking-related hospitalizations
timeFrame: 2 years
measure: Number of smoking-related hospitalizations
timeFrame: 1 year
measure: Smoking abstinence
timeFrame: 3 years
measure: Smoking abstinence
timeFrame: 2 years
measure: Smoking abstinence
timeFrame: 1 year
measure: Smoking abstinence
timeFrame: 6 months
measure: Number of Participants with Adverse Events as a Measure of Safety and tolerability
timeFrame: 3 years
measure: Number of Participants with Adverse Events as a Measure of Safety and tolerability
timeFrame: 2 years
measure: Number of Participants with Adverse Events as a Measure of Safety and tolerability
timeFrame: 1 year
measure: Number of Participants with Adverse Events as a Measure of Safety and tolerability
timeFrame: 6 months
measure: Adherence to e-cigarette smoking
timeFrame: 3 years
measure: Adherence to e-cigarette smoking
timeFrame: 2 years
measure: Adherence to e-cigarette smoking
timeFrame: 1 year
measure: Adherence to e-cigarette smoking
timeFrame: 6 months
measure: Traditional and electronic smoking (overall smoking) cessation
timeFrame: 1 year
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: Department of Medicine and Aging Sciences, University of Chieti
state: CH
Study officials:
affiliation: Department of Medicine and Aging Sciences, University of Chieti, Italy
name: Lamberto Manzoli, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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;10(6):e0129443. doi: 10.1371/journal.pone.0129443. eCollection 2015.
citation: 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.