Smoking CessationESTxENDSNCT03632421
The ESTxENDS Trial- Substudy on the Effects of Using Electronic Nicotine Delivery Systems (ENDS/Vaporizer/E-cig) on Respiratory Symptoms
A study testing ENDS (vaporizer/e-cig) and smoking cessation counseling and Smoking cessation counseling in people with Smoking Cessation and Respiratory Disease, run by University of Bern at 5 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Respiratory Disease
- What is being tested?
- ENDS (vaporizer/e-cig) and smoking cessation counseling and Smoking cessation counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,246 participants
- Where
- 5 sitesSwitzerland
- Study dates
- 16 Jul 2018to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Switzerland5 sites
University Clinic for General Internal Medicine, Bern University Hospital
Bern, 3010
Département de médecine interne, Hôpitaux universitaires de Genève
Geneva, 1211
Unisanté, Centre universitaire de médecine générale et santé publique, Université de Lausanne
Lausanne, Canton of Vaud, 1011
Lungenzentrum, Klinik für Pneumologie und Schlafmedizin, Kantonsspital St. Gallen
Sankt Gallen
Epidemiology, Biostatistics and Prevention Institute (EBPI), University of Zurich
Zurich
About this study
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
--> 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.
Read more
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.
- Conditions
- Smoking Cessation, Respiratory Disease
- Being tested
- ENDS (vaporizer/e-cig) and smoking cessation counseling, Smoking cessation counseling
- Medical subject headings
- Smoking Cessation, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENDS (vaporizer/e-cig) and smoking cessation counselingOther
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 will be allowed to additionally use nicotine replacement therapy. All participants will be followed over a 24-month period. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date one week later and again at week 2, 4 and 8 after the target quit date. After 6, 12 and 24 months, participants will be asked to come to a clinical visit.
Smoking cessation counselingOther
Participants in the control group will receive smoking cessation counseling only. Participants will be allowed to additionally use nicotine replacement therapy. All participants will be followed over a 24-month period. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date one week later and again at week 2, 4 and 8 after the target quit date. After 6, 12 and 24 months, participants will be asked to come to a clinical visit.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Other: ENDS (vaporizer/e-cig) and smoking cessation counseling |
| Control group | Active comparator | Not described Receives: Other: Smoking cessation counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of respiratory symptoms (Chronic obstructive pulmonary disease (COPD)_1
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.
Measured: 6 months post quit date
Assessment of respiratory symptoms (Chronic obstructive pulmonary disease (COPD)_2
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.
Measured: 12 months post quit date
Assessment of respiratory symptoms (Chronic obstructive pulmonary disease (COPD)_3
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.
Measured: 24 months post quit date
Assessment of respiratory symptoms (Dyspnea)_1
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.
Measured: 6 months post quit date
Assessment of respiratory symptoms (Dyspnea)_2
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.
Measured: 12 months post quit date
Assessment of respiratory symptoms (Dyspnea)_3
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.
Measured: 24 months post quit date
Assessment of respiratory symptoms (Asthma)_1
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.
Measured: 6 months post quit date
Assessment of respiratory symptoms (Asthma)_2
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.
Measured: 12 months post quit date
Assessment of respiratory symptoms (Asthma)_3
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.
Measured: 24 months post quit date
Secondary outcomes (15)
Change in respiratory symptoms (Chronic obstructive pulmonary disease (COPD)
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.
Measured: Change from baseline to 6,12, 24 months post quit date
Change in respiratory symptoms (Dyspnea)
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.
Measured: Change from baseline to 6,12, 24 months post quit date
Change in respiratory symptoms (Asthma)
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.
Measured: Change from baseline to 6,12, 24 months post quit date
Assessment of adverse respiratory effects due to ENDS use
Adverse respiratory effects due to ENDS use are assessed using questionnaires or over the phone.
Measured: 1 week post quit date
Assessment of adverse respiratory effects due to ENDS use
Adverse respiratory effects due to ENDS use are assessed using questionnaires or over the phone.
Measured: 2 weeks post quit date
Assessment of adverse respiratory effects due to ENDS use
Adverse respiratory effects due to ENDS use are assessed using questionnaires or over the phone.
Measured: 4 weeks post quit date
Assessment of adverse respiratory effects due to ENDS use
Adverse respiratory effects due to ENDS use are assessed using questionnaires or over the phone.
Measured: 8 weeks post quit date
Assessment of adverse respiratory effects due to ENDS use
Adverse respiratory effects due to ENDS use are assessed using questionnaires or over the phone.
Measured: 6,12, 24 months post quit date
Assessment of adverse respiratory effects due tobacco cigarette use
Adverse respiratory effects due to tobacco cigarette use use are assessed using questionnaires or over the phone.
Measured: Baseline
Assessment of adverse respiratory effects due tobacco cigarette use
Adverse respiratory effects due to tobacco cigarette use use are assessed using questionnaires or over the phone.
Measured: 1 week post quit date
Assessment of adverse respiratory effects due tobacco cigarette use
Adverse respiratory effects due to tobacco cigarette use use are assessed using questionnaires or over the phone.
Measured: 2 weeks post quit date
Assessment of adverse respiratory effects due tobacco cigarette use
Adverse respiratory effects due to tobacco cigarette use use are assessed using questionnaires or over the phone.
Measured: 4 weeks post quit date
Assessment of adverse respiratory effects due tobacco cigarette use
Adverse respiratory effects due to tobacco cigarette use use are assessed using questionnaires or over the phone.
Measured: 8 weeks post quit date
Assessment of adverse respiratory effects due tobacco cigarette use
Adverse respiratory effects due to tobacco cigarette use use are assessed using questionnaires or over the phone.
Measured: 6,12, 24 months post quit date
Assessment of adverse respiratory effects due tobacco cigarette use
Adverse respiratory effects due to tobacco cigarette use use are assessed using questionnaires or over the phone.
Measured: Change from baseline to 6,12, 24 months post quit date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start16 Jul 2018
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,246 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne, University of Geneva, Switzerland, University of Zurich, State Hospital, St. Gallen, Swiss National Science Foundation, Krebsforschung Schweiz, Bern, Switzerland, Federal Office of Public Health, Switzerland
- Responsible party
- Sponsor
- Investigators
- Reto Auer, Prof.Dr.med, Study director, Berner Institut für Hausarztmedizin; Universität Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03632421
- Sponsor's protocol ID
- 2017-02332a
- Other IDs
- 2017
- Acronym
- ESTxENDS
- Status last verified
- Nov 2023
- First submitted
- 25 Jun 2018
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 23343063Farsalinos 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.
PubMed 25083263Caponnetto 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.
PubMed 23826093Flouris 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.
PubMed 23363041Vardavas 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.
PubMed 22194587Lim 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.
PubMed 24795794
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03632421
- Acronym / sponsor ID
- ESTxENDS / 2017-02332a
- Conditions
- Smoking Cessation, Respiratory Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,246 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Collaborators
- University of Lausanne, University of Geneva, Switzerland, University of Zurich, State Hospital, St. Gallen, Swiss National Science Foundation, Krebsforschung Schweiz, Bern, Switzerland, Federal Office of Public Health, Switzerland
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
--> 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: ENDS (vaporizer/e-cig) and smoking cessation counseling |
| Control group | Active comparator | Other: Smoking cessation counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ENDS (vaporizer/e-cig) and smoking cessation counselingParticipants 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 will be allowed to additionally use nicotine replacement therapy. All participants will be followed over a 24-month period. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date one week later and again at week 2, 4 and 8 after the target quit date. After 6, 12 and 24 months, participants will be asked to come to a clinical visit. | Other | Intervention group |
| Smoking cessation counselingParticipants in the control group will receive smoking cessation counseling only. Participants will be allowed to additionally use nicotine replacement therapy. All participants will be followed over a 24-month period. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date one week later and again at week 2, 4 and 8 after the target quit date. After 6, 12 and 24 months, participants will be asked to come to a clinical visit. | Other | Control group |
Primary outcome
Assessment of respiratory symptoms (Chronic obstructive pulmonary disease (COPD)_1
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Assessment of respiratory symptoms (Asthma)_2
Time frame: 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
Time frame: 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.
15 secondary outcomes
Change in respiratory symptoms (Chronic obstructive pulmonary disease (COPD)
Time frame: Change from baseline to 6,12, 24 months post quit date
Change in respiratory symptoms (Dyspnea)
Time frame: Change from baseline to 6,12, 24 months post quit date
Change in respiratory symptoms (Asthma)
Time frame: Change from baseline to 6,12, 24 months post quit date
Assessment of adverse respiratory effects due to ENDS use
Time frame: 1 week post quit date
Assessment of adverse respiratory effects due to ENDS use
Time frame: 2 weeks post quit date
Assessment of adverse respiratory effects due to ENDS use
Time frame: 4 weeks post quit date
Assessment of adverse respiratory effects due to ENDS use
Time frame: 8 weeks post quit date
Assessment of adverse respiratory effects due to ENDS use
Time frame: 6,12, 24 months post quit date
Assessment of adverse respiratory effects due tobacco cigarette use
Time frame: Baseline
Assessment of adverse respiratory effects due tobacco cigarette use
Time frame: 1 week post quit date
Assessment of adverse respiratory effects due tobacco cigarette use
Time frame: 2 weeks post quit date
Assessment of adverse respiratory effects due tobacco cigarette use
Time frame: 4 weeks post quit date
Assessment of adverse respiratory effects due tobacco cigarette use
Time frame: 8 weeks post quit date
Assessment of adverse respiratory effects due tobacco cigarette use
Time frame: 6,12, 24 months post quit date
Assessment of adverse respiratory effects due tobacco cigarette use
Time frame: Change from baseline to 6,12, 24 months post quit date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Background: PubMed 23343063Jha 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.
- Background: PubMed 25083263Farsalinos 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.
- Background: PubMed 23826093Caponnetto 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.
- Background: PubMed 23363041Flouris 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reto Auer, Prof.Dr.med study director
Berner Institut für Hausarztmedizin; Universität Bern
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ENDS (vaporizer/e-cig) and smoking cessation counseling and Smoking cessation counseling in people with Smoking Cessation and Respiratory Disease, run by University of Bern at 5 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of respiratory symptoms (Chronic obstructive pulmonary disease (COPD)_1 (time frame: 6 months post quit date). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03632421, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.