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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01785537
Recruitment Status : Unknown
Verified May 2017 by Lamberto Manzoli, Università degli Studi 'G. d'Annunzio' Chieti e Pescara.
Recruitment status was:  Active, not recruiting
First Posted : February 7, 2013
Last Update Posted : May 5, 2017
Sponsor:
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
Information provided by (Responsible Party):
Lamberto Manzoli, Università degli Studi 'G. d'Annunzio' Chieti e Pescara

Tracking Information
First Submitted Date February 1, 2013
First Posted Date February 7, 2013
Last Update Posted Date May 5, 2017
Study Start Date October 2013
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 27, 2013)
  • Traditional smoking cessation rate [ Time Frame: 5 years ]
    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.
  • Change from baseline in the number of traditional cigarette smoked [ Time Frame: 6, 12, 24, 36 and 60 months. ]
    Change in the average self-reported number of traditional cigarette smoked per day.
Original Primary Outcome Measures
 (submitted: February 6, 2013)
Time to hospitalization for cardiovascular diseases, COPD and smoking-related cancer. [ Time Frame: 5 years ]
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.
Change History
Current Secondary Outcome Measures
 (submitted: May 27, 2013)
  • Rate of subjects with smoking-related hospitalizations [ Time Frame: 5 years ]
    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.
  • Number of smoking-related hospitalizations [ Time Frame: 5 years ]
    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.
  • Number of hospitalizations for cardiovascular diseases [ Time Frame: 5 years ]
    Mean number of hospital admissions for cardiovascular diseases. Each admissions of the same subject will be counted.
  • Number of hospitalizations for smoking-related cancers [ Time Frame: 5 years ]
    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.
  • Change from baseline in self-reported quality of life [ Time Frame: 6, 12, 24 and 36 months ]
    Change in the average quality of life according to EuroQol EQ-D3.
  • Time to hospitalization for cardiovascular diseases, COPD and smoking-related cancer. [ Time Frame: 5 year ]
    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.
  • Number of Participants with Adverse Events as a Measure of Safety and tolerability [ Time Frame: 5 years ]
    Self-reported side effects as measured by VAS and a structured report form.
  • Adherence to e-cigarette smoking [ Time Frame: 5 years ]
    Number of months of continued e-cigarette smoking in groups EC and Mixed.
  • Time to hospitalization for cardiovascular diseases, COPD and smoking-related cancer. [ Time Frame: 3 years ]
    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.
  • Time to hospitalization for cardiovascular diseases, COPD and smoking-related cancer. [ Time Frame: 2 years ]
    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.
  • Rate of subjects with smoking-related hospitalizations [ Time Frame: 3 years ]
    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.
  • Rate of subjects with smoking-related hospitalizations [ Time Frame: 2 years ]
    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.
  • Number of smoking-related hospitalizations [ Time Frame: 2 years ]
    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.
  • Number of smoking-related hospitalizations [ Time Frame: 1 year ]
    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.
  • Smoking abstinence [ Time Frame: 3 years ]
    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.
  • Smoking abstinence [ Time Frame: 2 years ]
    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.
  • Smoking abstinence [ Time Frame: 1 year ]
    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.
  • Smoking abstinence [ Time Frame: 6 months ]
    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.
  • Number of Participants with Adverse Events as a Measure of Safety and tolerability [ Time Frame: 3 years ]
    Self-reported side effects as measured by VAS and a structured report form.
  • Number of Participants with Adverse Events as a Measure of Safety and tolerability [ Time Frame: 2 years ]
    Self-reported side effects as measured by VAS and a structured report form.
  • Number of Participants with Adverse Events as a Measure of Safety and tolerability [ Time Frame: 1 year ]
    Self-reported side effects as measured by VAS and a structured report form.
  • Number of Participants with Adverse Events as a Measure of Safety and tolerability [ Time Frame: 6 months ]
    Self-reported side effects as measured by VAS and a structured report form.
  • Adherence to e-cigarette smoking [ Time Frame: 3 years ]
    Number of months of continued e-cigarette smoking in groups EC and Mixed.
  • Adherence to e-cigarette smoking [ Time Frame: 2 years ]
    Number of months of continued e-cigarette smoking in groups EC and Mixed.
  • Adherence to e-cigarette smoking [ Time Frame: 1 year ]
    Number of months of continued e-cigarette smoking in groups EC and Mixed.
  • Adherence to e-cigarette smoking [ Time Frame: 6 months ]
    Number of months of continued e-cigarette smoking in groups EC and Mixed.
  • Traditional and electronic smoking (overall smoking) cessation [ Time Frame: 1 year ]
    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.
Original Secondary Outcome Measures
 (submitted: February 6, 2013)
  • Rate of subjects with smoking-related hospitalizations [ Time Frame: 5 years ]
    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.
  • Number of smoking-related hospitalizations [ Time Frame: 5 years ]
    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.
  • Number of hospitalizations for cardiovascular diseases [ Time Frame: 5 years ]
    Mean number of hospital admissions for cardiovascular diseases. Each admissions of the same subject will be counted.
  • Number of hospitalizations for smoking-related cancers [ Time Frame: 5 years ]
    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.
  • Change from baseline in self-reported quality of life [ Time Frame: 6, 12, 24 and 36 months ]
    Change in the average quality of life according to EuroQol EQ-D3.
  • Change from baseline in the number of traditional cigarette smoked [ Time Frame: 6, 12, 24, 36 and 60 months. ]
    Change in the average self-reported number of traditional cigarette smoked per day.
  • Smoking abstinence [ Time Frame: 5 year ]
    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.
  • Number of Participants with Adverse Events as a Measure of Safety and tolerability [ Time Frame: 5 years ]
    Self-reported side effects as measured by VAS and a structured report form.
  • Adherence to e-cigarette smoking [ Time Frame: 5 years ]
    Number of months of continued e-cigarette smoking in groups EC and Mixed.
  • Time to hospitalization for cardiovascular diseases, COPD and smoking-related cancer. [ Time Frame: 3 years ]
    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.
  • Time to hospitalization for cardiovascular diseases, COPD and smoking-related cancer. [ Time Frame: 2 years ]
    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.
  • Rate of subjects with smoking-related hospitalizations [ Time Frame: 3 years ]
    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.
  • Rate of subjects with smoking-related hospitalizations [ Time Frame: 2 years ]
    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.
  • Number of smoking-related hospitalizations [ Time Frame: 2 years ]
    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.
  • Number of smoking-related hospitalizations [ Time Frame: 1 year ]
    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.
  • Smoking abstinence [ Time Frame: 3 years ]
    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.
  • Smoking abstinence [ Time Frame: 2 years ]
    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.
  • Smoking abstinence [ Time Frame: 1 year ]
    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.
  • Smoking abstinence [ Time Frame: 6 months ]
    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.
  • Number of Participants with Adverse Events as a Measure of Safety and tolerability [ Time Frame: 3 years ]
    Self-reported side effects as measured by VAS and a structured report form.
  • Number of Participants with Adverse Events as a Measure of Safety and tolerability [ Time Frame: 2 years ]
    Self-reported side effects as measured by VAS and a structured report form.
  • Number of Participants with Adverse Events as a Measure of Safety and tolerability [ Time Frame: 1 year ]
    Self-reported side effects as measured by VAS and a structured report form.
  • Number of Participants with Adverse Events as a Measure of Safety and tolerability [ Time Frame: 6 months ]
    Self-reported side effects as measured by VAS and a structured report form.
  • Adherence to e-cigarette smoking [ Time Frame: 3 years ]
    Number of months of continued e-cigarette smoking in groups EC and Mixed.
  • Adherence to e-cigarette smoking [ Time Frame: 2 years ]
    Number of months of continued e-cigarette smoking in groups EC and Mixed.
  • Adherence to e-cigarette smoking [ Time Frame: 1 year ]
    Number of months of continued e-cigarette smoking in groups EC and Mixed.
  • Adherence to e-cigarette smoking [ Time Frame: 6 months ]
    Number of months of continued e-cigarette smoking in groups EC and Mixed.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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.
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Cardiovascular Diseases
  • Chronic Obstructive Pulmonary Diseases
  • Cancer of the Lung
  • Cancer of the Bladder
  • Cancer of the Stomach
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: February 6, 2013)
1050
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 30 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT01785537
Other Study ID Numbers CHLM001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Lamberto Manzoli, Università degli Studi 'G. d'Annunzio' Chieti e Pescara
Study 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
PRS Account Università degli Studi 'G. d'Annunzio' Chieti e Pescara
Verification Date May 2017