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

U

Università degli Studi 'G. d'Annunzio' Chieti e Pescara

Status

Unknown

Conditions

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

Study type

Observational

Funder types

Other

Identifiers

NCT01785537
CHLM001

Details and patient eligibility

About

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.

Enrollment

1,050 estimated patients

Sex

All

Ages

30 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

1,050 participants in 3 patient groups

E-cigarettes only
Description:
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
Description:
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
Description:
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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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