The ESTxENDS Trial- Substudy on the Effects of Using Electronic Nicotine Delivery Systems (ENDS/Vaporizer/E-cig) on Respiratory Symptoms

University of Bern

Status

Completed

Conditions

Respiratory Disease

Smoking Cessation

Treatments

Other: Smoking cessation counseling

Other: ENDS (vaporizer/e-cig) and smoking cessation counseling

Study type

Interventional

Funder types

Other

Identifiers

NCT03632421

2017-02332a

Details and patient eligibility

About

--> 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.

Enrollment

1,246 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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