Overview

This trial is active, not recruiting.

Conditions cardiovascular diseases, chronic obstructive pulmonary diseases, cancer of the lung, cancer of the bladder, cancer of the stomach
Sponsor Università degli Studi 'G. d'Annunzio' Chieti e Pescara
Collaborator University of Roma La Sapienza
Start date October 2013
End date December 2019
Trial size 1050 participants
Trial identifier NCT01785537, CHLM001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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

Primary Outcomes

Measure
Traditional smoking cessation rate
time frame: 5 years
Change from baseline in the number of traditional cigarette smoked
time frame: 6, 12, 24, 36 and 60 months.

Secondary Outcomes

Measure
Rate of subjects with smoking-related hospitalizations
time frame: 5 years
Number of smoking-related hospitalizations
time frame: 5 years
Number of hospitalizations for cardiovascular diseases
time frame: 5 years
Number of hospitalizations for smoking-related cancers
time frame: 5 years
Change from baseline in self-reported quality of life
time frame: 6, 12, 24 and 36 months
Time to hospitalization for cardiovascular diseases, COPD and smoking-related cancer.
time frame: 5 year
Number of Participants with Adverse Events as a Measure of Safety and tolerability
time frame: 5 years
Adherence to e-cigarette smoking
time frame: 5 years
Time to hospitalization for cardiovascular diseases, COPD and smoking-related cancer.
time frame: 3 years
Time to hospitalization for cardiovascular diseases, COPD and smoking-related cancer.
time frame: 2 years
Rate of subjects with smoking-related hospitalizations
time frame: 3 years
Rate of subjects with smoking-related hospitalizations
time frame: 2 years
Number of smoking-related hospitalizations
time frame: 2 years
Number of smoking-related hospitalizations
time frame: 1 year
Smoking abstinence
time frame: 3 years
Smoking abstinence
time frame: 2 years
Smoking abstinence
time frame: 1 year
Smoking abstinence
time frame: 6 months
Number of Participants with Adverse Events as a Measure of Safety and tolerability
time frame: 3 years
Number of Participants with Adverse Events as a Measure of Safety and tolerability
time frame: 2 years
Number of Participants with Adverse Events as a Measure of Safety and tolerability
time frame: 1 year
Number of Participants with Adverse Events as a Measure of Safety and tolerability
time frame: 6 months
Adherence to e-cigarette smoking
time frame: 3 years
Adherence to e-cigarette smoking
time frame: 2 years
Adherence to e-cigarette smoking
time frame: 1 year
Adherence to e-cigarette smoking
time frame: 6 months
Traditional and electronic smoking (overall smoking) cessation
time frame: 1 year

Eligibility Criteria

Male or female participants from 30 years up to 80 years old.

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.

Additional Information

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.
Principal investigator Lamberto Manzoli, MD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Università degli Studi 'G. d'Annunzio' Chieti e Pescara.