The ESTxENDS Trial- Substudy on the Effects of Using Electronic Nicotine Delivery Systems (ENDS/Vaporizer/E-cig) on Respiratory Symptoms
- Conditions
- Smoking CessationRespiratory Disease
- Interventions
- Other: ENDS (vaporizer/e-cig) and smoking cessation counselingOther: Smoking cessation counseling
- Registration Number
- NCT03632421
- Lead Sponsor
- University of Bern
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1246
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group ENDS (vaporizer/e-cig) and smoking cessation counseling - Control group Smoking cessation counseling -
- Primary Outcome Measures
Name Time Method Assessment of respiratory symptoms (Asthma)_2 12 months post quit date Measured using the Asthma Control Test ACT and questions from the European community respiratory health survey ECRHS. The ACT is self-administered tool with 5-items assessing the frequency of shortness of breath and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control. The scaling of items is on a 5-point scale. The scores range from 5 to 25, with higher scores reflecting greater asthma control.
Assessment of respiratory symptoms (Asthma)_3 24 months post quit date Measured using the Asthma Control Test ACT and questions from the European community respiratory health survey ECRHS. The ACT is self-administered tool with 5-items assessing the frequency of shortness of breath and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control. The scaling of items is on a 5-point scale. The scores range from 5 to 25, with higher scores reflecting greater asthma control.
Assessment of respiratory symptoms (Chronic obstructive pulmonary disease (COPD)_1 6 months post quit date Measured using COPD assessment test (CAT). The COPD Assessment Test (CAT) is a questionnaire for people with COPD. It is designed to measure the impact of COPD on a person's life, and how this changes over time. The CAT has 8 items and the scaling of each item is from 1 to 5. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Assessment of respiratory symptoms (Chronic obstructive pulmonary disease (COPD)_2 12 months post quit date Measured using COPD assessment test (CAT). The COPD Assessment Test (CAT) is a questionnaire for people with COPD. It is designed to measure the impact of COPD on a person's life, and how this changes over time. The CAT has 8 items and the scaling of each item is from 1 to 5. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Assessment of respiratory symptoms (Chronic obstructive pulmonary disease (COPD)_3 24 months post quit date Measured using COPD assessment test (CAT). The COPD Assessment Test (CAT) is a questionnaire for people with COPD. It is designed to measure the impact of COPD on a person's life, and how this changes over time. The CAT has 8 items and the scaling of each item is from 1 to 5. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Assessment of respiratory symptoms (Dyspnea)_1 6 months post quit date Measured using mMRC- Dyspnea scale. The mMRC Dyspnea Scale quantifies disability attributable to breathlessness, and is useful for characterizing baseline dyspnea in patients with respiratory diseases. The severity of dyspnea is rated on a scale of 0 to 4.
Assessment of respiratory symptoms (Dyspnea)_2 12 months post quit date Measured using mMRC- Dyspnea scale. The mMRC Dyspnea Scale quantifies disability attributable to breathlessness, and is useful for characterizing baseline dyspnea in patients with respiratory diseases. The severity of dyspnea is rated on a scale of 0 to 4.
Assessment of respiratory symptoms (Dyspnea)_3 24 months post quit date Measured using mMRC- Dyspnea scale. The mMRC Dyspnea Scale quantifies disability attributable to breathlessness, and is useful for characterizing baseline dyspnea in patients with respiratory diseases. The severity of dyspnea is rated on a scale of 0 to 4.
Assessment of respiratory symptoms (Asthma)_1 6 months post quit date Measured using the Asthma Control Test ACT and questions from the European community respiratory health survey ECRHS. The ACT is self-administered tool with 5-items assessing the frequency of shortness of breath and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control. The scaling of items is on a 5-point scale. The scores range from 5 to 25, with higher scores reflecting greater asthma control.
- Secondary Outcome Measures
Name Time Method Change in respiratory symptoms (Asthma) Change from baseline to 6,12, 24 months post quit date Measured using the Asthma Control Test ACT and questions from the European community respiratory health survey ECRHS. The ACT is self-administered tool with 5-items assessing the frequency of shortness of breath and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control. The scaling of items is on a 5-point scale. The scores range from 5 to 25, with higher scores reflecting greater asthma control.
Assessment of adverse respiratory effects due to ENDS use 6,12, 24 months post quit date Adverse respiratory effects due to ENDS use are assessed using questionnaires or over the phone.
Assessment of adverse respiratory effects due tobacco cigarette use Change from baseline to 6,12, 24 months post quit date Adverse respiratory effects due to tobacco cigarette use use are assessed using questionnaires or over the phone.
Change in respiratory symptoms (Chronic obstructive pulmonary disease (COPD) Change from baseline to 6,12, 24 months post quit date Measured using COPD assessment test (CAT). The COPD Assessment Test (CAT) is a questionnaire for people with COPD. It is designed to measure the impact of COPD on a person's life, and how this changes over time. The CAT has 8 items and the scaling of each item is from 1 to 5. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Change in respiratory symptoms (Dyspnea) Change from baseline to 6,12, 24 months post quit date Measured using mMRC- Dyspnea scale. The mMRC Dyspnea Scale quantifies disability attributable to breathlessness, and is useful for characterizing baseline dyspnea in patients with respiratory diseases. The severity of dyspnea is rated on a scale of 0 to 4.
Trial Locations
- Locations (5)
Lungenzentrum, Klinik für Pneumologie und Schlafmedizin, Kantonsspital St. Gallen
🇨ðŸ‡Saint Gallen, Switzerland
Unisanté, Centre universitaire de médecine générale et santé publique, Université de Lausanne
🇨ðŸ‡Lausanne, Vaud, Switzerland
University Clinic for General Internal Medicine, Bern University Hospital
🇨ðŸ‡Bern, Switzerland
Epidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich
🇨ðŸ‡Zürich, Switzerland
Département de médecine interne, Hôpitaux universitaires de Genève
🇨ðŸ‡Geneva, Switzerland