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

NCT01785537 | Unknown DMC

• 1 other identifier: CHLM001
• Study Type: observational
• Target: 1,050
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (27)

• Rate of subjects with smoking-related hospitalizations

  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

Study Arms (3)

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

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Department of Medicine and Aging Sciences, University of Chieti

Chieti, CH, 66100, Italy

Location

Related Publications (3)

• 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.

  PMID: 24063569 BACKGROUND

• 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.

  PMID: 26061661 RESULT

• 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.

  PMID: 27272748 RESULT

MeSH Terms

Conditions

Cardiovascular Diseases; Pulmonary Disease, Chronic Obstructive; Lung Neoplasms; Urinary Bladder Neoplasms; Stomach Neoplasms; Cigarette Smoking

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Tobacco Smoking; Smoking; Behavior; Tobacco Use

Study Officials

• Lamberto Manzoli, MD, MPH

  Department of Medicine and Aging Sciences, University of Chieti, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Epidemiology and Public Health

Study Record Dates

• First Submitted: February 1, 2013
• First Posted: February 7, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: May 5, 2017

Record last verified: 2017-05

Locations

IT (1)