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.
Sponsor study identifier
observational
1,050
1 country
1
Study Start
October 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 1, 2013
Actual (reported)February 7, 2013
Actual (reported)October 2013
Date type not reportedThis date has not been verified as actual or estimated.
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Rate of subjects with smoking-related hospitalizations
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
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.
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
Adult residents in the Abruzzo and Lazio Region of Italy that are smokers of traditional or electronic cigarettes
Department of Medicine and Aging Sciences, University of Chieti
Chieti, CH, 66100, Italy
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.
Lamberto Manzoli, MD, MPH
Department of Medicine and Aging Sciences, University of Chieti, Italy
First Submitted
February 1, 2013
First Posted
February 7, 2013
Study Start
October 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2019
COPDGene/Lung Cancer Center Database
5 years
Number of smoking-related hospitalizations
5 years
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
Contact the study team to confirm eligibility.
Manzoli L, Flacco ME, Ferrante M, La Vecchia C, Siliquini R, Ricciardi W, Marzuillo C, Villari P, Fiore M. A cohort study of electronic cigarette use: Effectiveness and safety at 24 months. Tobacco Control 2016 Jun 7 (epub ahead of print). (doi: 10.1136/tobaccocontrol-2015-052822) Direct link: http://tobaccocontrol.bmj.com/content/early/2016/06/06/tobaccocontrol-2015-052822.full
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 5, 2017
Record last verified: 2017-05
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