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

This study is ongoing, but not recruiting participants.
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
ClinicalTrials.gov Identifier:
NCT01785537
First received: February 1, 2013
Last updated: May 2, 2017
Last verified: May 2017
  Purpose

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.


Condition
Cardiovascular Diseases Chronic Obstructive Pulmonary Diseases Cancer of the Lung Cancer of the Bladder Cancer of the Stomach

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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.

Resource links provided by NLM:


Further study details as provided by Lamberto Manzoli, Università degli Studi 'G. d'Annunzio' Chieti e Pescara:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 1050
Study Start Date: October 2013
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01785537

Locations
Italy
Department of Medicine and Aging Sciences, University of Chieti
Chieti, CH, Italy, 66100
Sponsors and Collaborators
Università degli Studi 'G. d'Annunzio' Chieti e Pescara
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
  More Information

Publications:
Responsible Party: Lamberto Manzoli, Associate Professor of Epidemiology and Public Health, Università degli Studi 'G. d'Annunzio' Chieti e Pescara
ClinicalTrials.gov Identifier: NCT01785537     History of Changes
Other Study ID Numbers: CHLM001
Study First Received: February 1, 2013
Last Updated: May 2, 2017

Keywords provided by Lamberto Manzoli, Università degli Studi 'G. d'Annunzio' Chieti e Pescara:
e-cigarette smoking
cigarette smoking
cardiovascular disease
hospitalization
chronic obstructive pulmonary diseases
observational study
efficacy
safety

Additional relevant MeSH terms:
Lung Diseases
Cardiovascular Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Neoplasms
Stomach Neoplasms
Urinary Bladder Neoplasms
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Urologic Neoplasms
Urogenital Neoplasms
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 19, 2017