Clinical trial NCT03632421: The ESTxENDS Trial- Substudy on the Effects of Using Electronic Nicotine Delivery Systems (ENDS/Vaporizer/E-cig) on Respiratory Symptoms
Official title: Substudy of Efficacy, Safety and Toxicology of Electronic Nicotine Delivery Systems as an Aid for Smoking Cessation (ESTxENDS Trial)- the Respiratory Symptoms Substudy of ESTxENDS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Respiratory Disease
Lead sponsor: University of Bern
Sponsor class: OTHER
Collaborators: name: University of Lausanne
name: University of Geneva, Switzerland
name: University of Zurich
name: State Hospital, St. Gallen
name: Swiss National Science Foundation
name: Krebsforschung Schweiz, Bern, Switzerland
name: Federal Office of Public Health, Switzerland
First posted: 2018-08-15
Enrollment: 1246
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: --\> This is a substudy of the main ESTxENDS trial (NCT03589989). Respiratory symptoms outcomes should be considered secondary outcomes of the main smoking cessation outcome formulated in NCT03589989.

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 the main ESTxENDS trial (NCT03589989), 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.


Eligibility criteria: Inclusion criteria:

* 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

Primary outcomes:
measure: Assessment of respiratory symptoms (Chronic obstructive pulmonary disease (COPD)_1
timeFrame: 6 months post quit date
measure: Assessment of respiratory symptoms (Chronic obstructive pulmonary disease (COPD)_2
timeFrame: 12 months post quit date
measure: Assessment of respiratory symptoms (Chronic obstructive pulmonary disease (COPD)_3
timeFrame: 24 months post quit date
measure: Assessment of respiratory symptoms (Dyspnea)_1
timeFrame: 6 months post quit date
measure: Assessment of respiratory symptoms (Dyspnea)_2
timeFrame: 12 months post quit date
measure: Assessment of respiratory symptoms (Dyspnea)_3
timeFrame: 24 months post quit date
measure: Assessment of respiratory symptoms (Asthma)_1
timeFrame: 6 months post quit date
measure: Assessment of respiratory symptoms (Asthma)_2
timeFrame: 12 months post quit date
measure: Assessment of respiratory symptoms (Asthma)_3
timeFrame: 24 months post quit date
Secondary outcomes:
measure: Change in respiratory symptoms (Chronic obstructive pulmonary disease (COPD)
timeFrame: Change from baseline to 6,12, 24 months post quit date
measure: Change in respiratory symptoms (Dyspnea)
timeFrame: Change from baseline to 6,12, 24 months post quit date
measure: Change in respiratory symptoms (Asthma)
timeFrame: Change from baseline to 6,12, 24 months post quit date
measure: Assessment of adverse respiratory effects due to ENDS use
timeFrame: 1 week post quit date
measure: Assessment of adverse respiratory effects due to ENDS use
timeFrame: 2 weeks post quit date
measure: Assessment of adverse respiratory effects due to ENDS use
timeFrame: 4 weeks post quit date
measure: Assessment of adverse respiratory effects due to ENDS use
timeFrame: 8 weeks post quit date
measure: Assessment of adverse respiratory effects due to ENDS use
timeFrame: 6,12, 24 months post quit date
measure: Assessment of adverse respiratory effects due tobacco cigarette use
timeFrame: Baseline
measure: Assessment of adverse respiratory effects due tobacco cigarette use
timeFrame: 1 week post quit date
measure: Assessment of adverse respiratory effects due tobacco cigarette use
timeFrame: 2 weeks post quit date
measure: Assessment of adverse respiratory effects due tobacco cigarette use
timeFrame: 4 weeks post quit date
measure: Assessment of adverse respiratory effects due tobacco cigarette use
timeFrame: 8 weeks post quit date
measure: Assessment of adverse respiratory effects due tobacco cigarette use
timeFrame: 6,12, 24 months post quit date
measure: Assessment of adverse respiratory effects due tobacco cigarette use
timeFrame: Change from baseline to 6,12, 24 months post quit date
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Unisanté, Centre universitaire de médecine générale et santé publique, Université de Lausanne
state: Vaud
city: Bern
country: Switzerland
facility: University Clinic for General Internal Medicine, Bern University Hospital
city: Geneva
country: Switzerland
facility: Département de médecine interne, Hôpitaux universitaires de Genève
city: Saint Gallen
country: Switzerland
facility: Lungenzentrum, Klinik für Pneumologie und Schlafmedizin, Kantonsspital St. Gallen
city: Zürich
country: Switzerland
facility: Epidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich
Study officials:
affiliation: Berner Institut für Hausarztmedizin; Universität Bern
name: Reto Auer, Prof.Dr.med
role: STUDY_DIRECTOR
References:
citation: Jha P, Ramasundarahettige C, Landsman V, Rostron B, Thun M, Anderson RN, McAfee T, Peto R. 21st-century hazards of smoking and benefits of cessation in the United States. N Engl J Med. 2013 Jan 24;368(4):341-50. doi: 10.1056/NEJMsa1211128.
citation: Farsalinos KE, Polosa R. Safety evaluation and risk assessment of electronic cigarettes as tobacco cigarette substitutes: a systematic review. Ther Adv Drug Saf. 2014 Apr;5(2):67-86. doi: 10.1177/2042098614524430.
citation: Caponnetto P, Campagna D, Cibella F, Morjaria JB, Caruso M, Russo C, Polosa R. EffiCiency and Safety of an eLectronic cigAreTte (ECLAT) as tobacco cigarettes substitute: a prospective 12-month randomized control design study. PLoS One. 2013 Jun 24;8(6):e66317. doi: 10.1371/journal.pone.0066317. Print 2013.
citation: Flouris AD, Chorti MS, Poulianiti KP, Jamurtas AZ, Kostikas K, Tzatzarakis MN, Wallace Hayes A, Tsatsakis AM, Koutedakis Y. Acute impact of active and passive electronic cigarette smoking on serum cotinine and lung function. Inhal Toxicol. 2013 Feb;25(2):91-101. doi: 10.3109/08958378.2012.758197.
citation: Vardavas CI, Anagnostopoulos N, Kougias M, Evangelopoulou V, Connolly GN, Behrakis PK. Short-term pulmonary effects of using an electronic cigarette: impact on respiratory flow resistance, impedance, and exhaled nitric oxide. Chest. 2012 Jun;141(6):1400-1406. doi: 10.1378/chest.11-2443. Epub 2011 Dec 22.
citation: Lim HB, Kim SH. Inhallation of e-Cigarette Cartridge Solution Aggravates Allergen-induced Airway Inflammation and Hyper-responsiveness in Mice. Toxicol Res. 2014 Mar;30(1):13-8. doi: 10.5487/TR.2014.30.1.013.