Informed Consent as documented by signature
Persons aged 18 or older
Currently smoking 5 or more cigarettes a day for at least 12 months
Willing to try to quit smoking within the next 3 months,
Persons providing a valid phone number, a valid email address and/or a valid postal address.
Exclusion criteria:
Known hypersensitivity or allergy to contents of the e-liquid
Participation in another study with investigational drug within the 30 days preceding the baseline visit and during the present study where interactions are to be expected
Women who are pregnant or breast feeding
Intention to become pregnant during the course of the scheduled study intervention, i.e. within the first 6-months of the study
Persons having used ENDS or tobacco heating systems regularly in the 3 months preceding the baseline visit
Persons having used nicotine replacement therapy (NRT) or other medications with demonstrated efficacy as an aid for smoking cessation such as varenicline or bupropion within the 3 months preceding the baseline visit
Persons who cannot attend the 6- month follow-up visit for any reason
Cannot understand instructions delivered in person or by phone, or otherwise unable to participate in study procedures
Source : Importé depuis le centre
Cohortes
Thérapie ou Intervention proposée
Cohortes
Nom
Condition médicale
Traitement
État du recrutement
Intervention group
Donnée non disponible
Donnée non disponible
Inconnu
Control group
Donnée non disponible
Donnée non disponible
Inconnu
Intervention group
État du recrutement
unknown
Control group
État du recrutement
unknown
Données à jour depuis :
19 octobre 2023
Description de l'étude
Description de l'étude
Résumé de l'étude
Cigarette smoking is the leading cause of preventable death in Switzerland. Cigarette smoking eventually kills one in two smokers, mostly through cancer, heart disease and respiratory failure. Recently, electronic nicotine delivery systems (ENDS; also called vaporizer or electronic cigarette) have become popular with smokers who want to stop smoking or reduce their exposure to inhaled chemicals since ENDS use appears to be safer than tobacco smoking.
Studies suggest that ENDS use improves health outcomes, such as reducing respiratory symptoms, and presents only minimal respiratory risks, such as mild throat irritation and dry cough.
In a prospective 6-month randomized, controlled trial evaluating smoking reduction/abstinence in 300 smokers not intending to quit experimenting two different nicotine strengths of a e-cigarette model compared to its non-nicotine choice, respiratory symptoms similarly improved in all three study groups. One study compared the short-term effects of cigarette smoking to ENDS use and found that cigarette smoking led to an acute reduction in lung function, which was not observed with ENDS. Findings on short-term airway resistance is conflicting. Short term increase in resistance in ENDS users might be caused by aerosolizing the liquid, and not by the same substances that harm lung function in cigarette smokers. Smokers who shifted from tobacco cigarettes to ENDS have offered anecdotes of dramatically improved lung function, but animal models suggest that ENDS liquids can increase markers of asthma. No large randomized trials have tested the effect of ENDS on respiratory symptoms.
For this trial, cigarette smokers motivated to quit smoking cigarettes will be included. Participants in the intervention group will receive an ENDS and nicotine-containing e-liquids, which they will be allowed to use ad libitum. Additionally, they will receive smoking cessation counseling. Participants in the control group will receive smoking cessation counseling only. All participants will be followed over a 24-months period. Respiratory symptoms such as chronic obstructive pulmonary disease (COPD), asthma and dyspnea will be assessed by means of questionnaires at baseline and at 6-, 12- and 24-months follow up. This trial will provide useful data on changes in respiratory symptoms in a large sample of participants.
Source : Importé depuis le centre
Centres participants
Sites
Centres participants
5
centres
DEPARTEMENT DE MEDECINE INTERNE, HOPITAUX UNIVERSITAIRES DE GENEVE
Geneva
SWITZERLAND
Recrutement local
État du recrutement:
FERMÉ
EPIDEMIOLOGY, BIOSTATISTICS AND PREVENTION INSTITUTE (EBPI), UNIVERSITY OF ZURICH
Zürich
SWITZERLAND
Recrutement local
État du recrutement:
FERMÉ
LUNGENZENTRUM, KLINIK FUR PNEUMOLOGIE UND SCHLAFMEDIZIN, KANTONSSPITAL ST. GALLEN
Saint gallen
SWITZERLAND
Recrutement local
État du recrutement:
FERMÉ
UNISANTE, CENTRE UNIVERSITAIRE DE MEDECINE GENERALE ET SANTE PUBLIQUE, UNIVERSITE DE LAUSANNE
Lausanne
VAUD, SWITZERLAND
Recrutement local
État du recrutement:
FERMÉ
UNIVERSITY CLINIC FOR GENERAL INTERNAL MEDICINE, BERN UNIVERSITY HOSPITAL
Bern
SWITZERLAND
Recrutement local
État du recrutement:
FERMÉ
Source d'information
Dernière modification :
19 octobre 2023
Données à jour depuis :
16 nov.
Origine des données :
clinicaltrials.gov
