Smoking CessationPulmENDSNCT03938298
The ESTxENDS Trial: Pulmonary Function Substudy
A study testing ENDS (vaporizer/e-cig) and smoking cessation counseling and Smoking cessation counseling in people with Smoking Cessation and Pulmonary Disease, run by University of Bern at 2 sites in Switzerland.
Trial summary
--> This is a substudy of the main ESTxENDS trial (NCT03589989). Pulmonary function outcomes should be considered secondary outcomes of the main smoking cessation outcome formulated in NCT03589989. 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, Pulmonary 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
- 130 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 10 Apr 2019to 28 Feb 2022
- 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
2 sites in 1 country.
Switzerland2 sites
University Clinic for General Internal Medicine, Bern University Hospital
Bern, 3010
Department of Pneumology
Bern
About this study
Official title: Substudy of Efficacy, Safety and Toxicology of Electronic Nicotine Delivery Systems as an Aid for Smoking Cessation (ESTxENDS): Pulmonary Function Substudy (PulmENDS)
--> This is a substudy of the main ESTxENDS trial (NCT03589989). Pulmonary function 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 and still more than a quarter of the Swiss population smokes cigarettes. Recently, electronic nicotine delivery systems (ENDS; also called vaporizer, e-cigarette 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. The inhaled ENDS aerosol appears safe in laboratory conditions, its long-term effects on pulmonary function remains unknown. This study will therefore investigate the impact of ENDS on lung function in smokers, who attempt to quit using ENDS compared with smokers, receiving only smoking cessation counseling with nicotine replacement therapy (NRT).
Read more
Multiple breath washout (MBW) is an established technique for assessment of peripheral airway function in pediatrics and its use is emerging in adult medicine, as it offers a better sensitivity to assess small airway disease before large airway involvement can be detected using conventional pulmonary function tests (PFT - spirometry, body plethysmography and diffusing capacity test). Preliminary evidence from limited studies suggest MBW parameters (LCI, Scond, Sacin) can be impaired in smokers with normal lung function and improve after smoking abstinence.
Primary objective of this substudy is to assess changes in LCI from baseline to 6 months post target quit date (TQD) in cigarette smokers randomized to the intervention group compared to the control group.
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 standard of care, i.e. smoking cessation counseling and encouragement to use NRT. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date and again at week 1, 2, 4 and 8 after the target quit date. Participants in the control group will receive only standard of care. All participants will be followed over a 6-month period. After 6 months, participants will be asked to come to a final clinical visit.
- Conditions
- Smoking Cessation, Pulmonary Disease
- Being tested
- ENDS (vaporizer/e-cig) and smoking cessation counseling, Smoking cessation counseling
- Medical subject headings
- Smoking Cessation, Lung Diseases
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 standards of care, i.e. smoking cessation counseling and encouragement to use NRT. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date and again at week 1, 2, 4 and 8 after the target quit date. All participants will be followed over a 6-month period. After 6 months, participants will be asked to come to a final clinical visit.
PFT and MBW will be performed at baseline and after the 6 months follow-up period in all participants of the substudy.
Smoking cessation counselingOther
Participants in the control group will receive standard of care only, i.e. i.e. smoking cessation counseling and encouragement to use NRT. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date and again at week 1, 2, 4 and 8 after the target quit date. All participants will be followed over a 6-month period. After 6 months, participants will be asked to come to a final clinical visit.
PFT and MBW will be performed at baseline and after the 6 months follow-up period in all participants of the substudy.
| 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.
Changes in Lung Clearance Index (LCI)
Measured by multiple breath washout (MBW) of a tracer gas (N2). LCI is defined as the cumulative expired volume/functional residual capacity (CEV/FRC) at 5% and 2.5% tracer gas concentration in the exhaled breath. An LCI with a z-score < + 1.645 (upper limit of normal according to Singer F et al, PLoS One. 2012;7(4):e36083) is considered normal.
Measured: Change from baseline to 6 months post quit date
Secondary outcomes (17)
Lung Clearance Index (LCI)
Measured by multiple breath washout (MBW) of a tracer gas (N2). LCI is defined as the cumulative expired volume/functional residual capacity (CEV/FRC) at 5% and 2.5% tracer gas concentration in the exhaled breath. An LCI with a z-score < + 1.645 (upper limit of normal according to Singer F et al, PLoS One. 2012;7(4):e36083) is considered normal.
Measured: 6 months post quit date
Changes in Scond and Sacin
Measured by multiple breath washout (MBW). MBW assesses ventilation of the peripheral airways.
Measured: Change from baseline to 6 months post quit date
Scond and Sacin
Measured by multiple breath washout (MBW). MBW assesses ventilation of the peripheral airways.
Measured: 6 months post quit date
Forced Expiratory Volume in 1 Second (FEV1)
Measured by spirometry. Spirometry is a conventional pulmonary function test measuring airflow.
Measured: 6 months post quit date
Changes in Forced Expiratory Volume in 1 Second (FEV1)
Measured by spirometry. Spirometry is a conventional pulmonary function test measuring airflow.
Measured: Change from baseline to 6 months post quit date
Forced Expiratory Volume in 1 Second/Functional Vital Capacity Ratio (FEV1/FVC)
Measured by spirometry. Spirometry is a conventional pulmonary function test measuring airflow.
Measured: 6 months post quit date
Changes in Forced Expiratory Volume in 1 Second/Functional Vital Capacity Ratio (FEV1/FVC)
Measured by spirometry. Spirometry is a conventional pulmonary function test measuring airflow.
Measured: Change from baseline to 6 months post quit date
Total Lung Capacity (TLC)
Measured by body plethysmography. Body plethysmography is a conventional pulmonary function test measuring lung volumes.
Measured: 6 months post quit date
Changes in Total Lung Capacity (TLC)
Measured by body plethysmography. Body plethysmography is a conventional pulmonary function test measuring lung volumes.
Measured: Change from baseline to 6 months post quit date
Residual Volume (RV)
Measured by body plethysmography. Body plethysmography is a conventional pulmonary function test measuring lung volumes.
Measured: 6 months post quit date
Changes in Residual Volume (RV)
Measured by body plethysmography. Body plethysmography is a conventional pulmonary function test measuring lung volumes.
Measured: Change from baseline to 6 months post quit date
Residual Volume to Total Lung Capacity (RV/TLC)
Measured by body plethysmography. Body plethysmography is a conventional pulmonary function test measuring lung volumes.
Measured: 6 months post quit date
Changes in Residual Volume to Total Lung Capacity (RV/TLC)
Measured by body plethysmography. Body plethysmography is a conventional pulmonary function test measuring lung volumes.
Measured: Change from baseline to 6 months post quit date
Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO)
Measured by diffusing capacity test.
Measured: 6 months post quit date
Changes in Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO)
Measured by diffusing capacity test.
Measured: Change from baseline to 6 months post quit date
Fraction of exhaled nitric oxide (FeNO)
Measured by the levels of nitric oxide in the exhaled breath.
Measured: 6 months post quit date
Changes in Fraction of exhaled nitric oxide (FeNO)
Measured by the levels of nitric oxide in the exhaled breath.
Measured: Change from baseline to 6 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 posted6 May 2019
- Study start10 Apr 2019
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation, Bernese Lung League, Insel Gruppe AG, University Hospital Bern
- Responsible party
- Sponsor
- Investigators
- Reto Auer, Prof.Dr.med, Study director, Berner Institut für Hausarztmedizin; Universität BernManuela Funke-Chambour, PD Dr. med., Principal investigator, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03938298
- Sponsor's protocol ID
- 2017-02332h
- Other IDs
- 2017
- Acronym
- PulmENDS
- Status last verified
- Nov 2023
- First submitted
- 2 May 2019
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25083263Subbarao P, Milla C, Aurora P, Davies JC, Davis SD, Hall GL, Heltshe S, Latzin P, Lindblad A, Pittman JE, Robinson PD, Rosenfeld M, Singer F, Starner TD, Ratjen F, Morgan W. Multiple-Breath Washout as a Lung Function Test in Cystic Fibrosis. A Cystic Fibrosis Foundation Workshop Report. Ann Am Thorac Soc. 2015 Jun;12(6):932-9. doi: 10.1513/AnnalsATS.201501-021FR.
PubMed 26075554Robinson PD, Latzin P, Verbanck S, Hall GL, Horsley A, Gappa M, Thamrin C, Arets HG, Aurora P, Fuchs SI, King GG, Lum S, Macleod K, Paiva M, Pillow JJ, Ranganathan S, Ratjen F, Singer F, Sonnappa S, Stocks J, Subbarao P, Thompson BR, Gustafsson PM. Consensus statement for inert gas washout measurement using multiple- and single- breath tests. Eur Respir J. 2013 Mar;41(3):507-22. doi: 10.1183/09031936.00069712. Epub 2013 Feb 8.
PubMed 23397305Jetmalani K, Thamrin C, Farah CS, Bertolin A, Chapman DG, Berend N, Salome CM, King GG. Peripheral airway dysfunction and relationship with symptoms in smokers with preserved spirometry. Respirology. 2018 May;23(5):512-518. doi: 10.1111/resp.13215. Epub 2017 Nov 15.
PubMed 29141272Verbanck S, Schuermans D, Meysman M, Paiva M, Vincken W. Noninvasive assessment of airway alterations in smokers: the small airways revisited. Am J Respir Crit Care Med. 2004 Aug 15;170(4):414-9. doi: 10.1164/rccm.200401-037OC. Epub 2004 May 6.
PubMed 15130906Verbanck S, Schuermans D, Paiva M, Meysman M, Vincken W. Small airway function improvement after smoking cessation in smokers without airway obstruction. Am J Respir Crit Care Med. 2006 Oct 15;174(8):853-7. doi: 10.1164/rccm.200603-422OC. Epub 2006 Jun 23.
PubMed 16799076Singer F, Houltz B, Latzin P, Robinson P, Gustafsson P. A realistic validation study of a new nitrogen multiple-breath washout system. PLoS One. 2012;7(4):e36083. doi: 10.1371/journal.pone.0036083. Epub 2012 Apr 27.
PubMed 22558338
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): Pulmonary Function Substudy (PulmENDS)
- ClinicalTrials.gov ID
- NCT03938298
- Acronym / sponsor ID
- PulmENDS / 2017-02332h
- Conditions
- Smoking Cessation, Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation, Bernese Lung League, Insel Gruppe AG, University Hospital Bern
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 6 May 2019 (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). Pulmonary function 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 and still more than a quarter of the Swiss population smokes cigarettes. Recently, electronic nicotine delivery systems (ENDS; also called vaporizer, e-cigarette 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. The inhaled ENDS aerosol appears safe in laboratory conditions, its long-term effects on pulmonary function remains unknown. This study will therefore investigate the impact of ENDS on lung function in smokers, who attempt to quit using ENDS compared with smokers, receiving only smoking cessation counseling with nicotine replacement therapy (NRT).
Multiple breath washout (MBW) is an established technique for assessment of peripheral airway function in pediatrics and its use is emerging in adult medicine, as it offers a better sensitivity to assess small airway disease before large airway involvement can be detected using conventional pulmonary function tests (PFT - spirometry, body plethysmography and diffusing capacity test). Preliminary evidence from limited studies suggest MBW parameters (LCI, Scond, Sacin) can be impaired in smokers with normal lung function and improve after smoking abstinence.
Primary objective of this substudy is to assess changes in LCI from baseline to 6 months post target quit date (TQD) in cigarette smokers randomized to the intervention group compared to the control group.
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 standard of care, i.e. smoking cessation counseling and encouragement to use NRT. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date and again at week 1, 2, 4 and 8 after the target quit date. Participants in the control group will receive only standard of care. All participants will be followed over a 6-month period. After 6 months, participants will be asked to come to a final clinical visit.
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 standards of care, i.e. smoking cessation counseling and encouragement to use NRT. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date and again at week 1, 2, 4 and 8 after the target quit date. All participants will be followed over a 6-month period. After 6 months, participants will be asked to come to a final clinical visit. PFT and MBW will be performed at baseline and after the 6 months follow-up period in all participants of the substudy. | Other | Intervention group |
| Smoking cessation counselingParticipants in the control group will receive standard of care only, i.e. i.e. smoking cessation counseling and encouragement to use NRT. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date and again at week 1, 2, 4 and 8 after the target quit date. All participants will be followed over a 6-month period. After 6 months, participants will be asked to come to a final clinical visit. PFT and MBW will be performed at baseline and after the 6 months follow-up period in all participants of the substudy. | Other | Control group |
Primary outcome
Changes in Lung Clearance Index (LCI)
Time frame: Change from baseline to 6 months post quit date
Measured by multiple breath washout (MBW) of a tracer gas (N2). LCI is defined as the cumulative expired volume/functional residual capacity (CEV/FRC) at 5% and 2.5% tracer gas concentration in the exhaled breath. An LCI with a z-score < + 1.645 (upper limit of normal according to Singer F et al, PLoS One. 2012;7(4):e36083) is considered normal.
17 secondary outcomes
Lung Clearance Index (LCI)
Time frame: 6 months post quit date
Changes in Scond and Sacin
Time frame: Change from baseline to 6 months post quit date
Scond and Sacin
Time frame: 6 months post quit date
Forced Expiratory Volume in 1 Second (FEV1)
Time frame: 6 months post quit date
Changes in Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Change from baseline to 6 months post quit date
Forced Expiratory Volume in 1 Second/Functional Vital Capacity Ratio (FEV1/FVC)
Time frame: 6 months post quit date
Changes in Forced Expiratory Volume in 1 Second/Functional Vital Capacity Ratio (FEV1/FVC)
Time frame: Change from baseline to 6 months post quit date
Total Lung Capacity (TLC)
Time frame: 6 months post quit date
Changes in Total Lung Capacity (TLC)
Time frame: Change from baseline to 6 months post quit date
Residual Volume (RV)
Time frame: 6 months post quit date
Changes in Residual Volume (RV)
Time frame: Change from baseline to 6 months post quit date
Residual Volume to Total Lung Capacity (RV/TLC)
Time frame: 6 months post quit date
Changes in Residual Volume to Total Lung Capacity (RV/TLC)
Time frame: Change from baseline to 6 months post quit date
Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO)
Time frame: 6 months post quit date
Changes in Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO)
Time frame: Change from baseline to 6 months post quit date
Fraction of exhaled nitric oxide (FeNO)
Time frame: 6 months post quit date
Changes in Fraction of exhaled nitric oxide (FeNO)
Time frame: Change from baseline to 6 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 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 26075554Subbarao P, Milla C, Aurora P, Davies JC, Davis SD, Hall GL, Heltshe S, Latzin P, Lindblad A, Pittman JE, Robinson PD, Rosenfeld M, Singer F, Starner TD, Ratjen F, Morgan W. Multiple-Breath Washout as a Lung Function Test in Cystic Fibrosis. A Cystic Fibrosis Foundation Workshop Report. Ann Am Thorac Soc. 2015 Jun;12(6):932-9. doi: 10.1513/AnnalsATS.201501-021FR.
- Background: PubMed 23397305Robinson PD, Latzin P, Verbanck S, Hall GL, Horsley A, Gappa M, Thamrin C, Arets HG, Aurora P, Fuchs SI, King GG, Lum S, Macleod K, Paiva M, Pillow JJ, Ranganathan S, Ratjen F, Singer F, Sonnappa S, Stocks J, Subbarao P, Thompson BR, Gustafsson PM. Consensus statement for inert gas washout measurement using multiple- and single- breath tests. Eur Respir J. 2013 Mar;41(3):507-22. doi: 10.1183/09031936.00069712. Epub 2013 Feb 8.
- Background: PubMed 29141272Jetmalani K, Thamrin C, Farah CS, Bertolin A, Chapman DG, Berend N, Salome CM, King GG. Peripheral airway dysfunction and relationship with symptoms in smokers with preserved spirometry. Respirology. 2018 May;23(5):512-518. doi: 10.1111/resp.13215. Epub 2017 Nov 15.
- Background: PubMed 15130906Verbanck S, Schuermans D, Meysman M, Paiva M, Vincken W. Noninvasive assessment of airway alterations in smokers: the small airways revisited. Am J Respir Crit Care Med. 2004 Aug 15;170(4):414-9. doi: 10.1164/rccm.200401-037OC. Epub 2004 May 6.
- Background: PubMed 16799076Verbanck S, Schuermans D, Paiva M, Meysman M, Vincken W. Small airway function improvement after smoking cessation in smokers without airway obstruction. Am J Respir Crit Care Med. 2006 Oct 15;174(8):853-7. doi: 10.1164/rccm.200603-422OC. Epub 2006 Jun 23.
- Background: PubMed 22558338Singer F, Houltz B, Latzin P, Robinson P, Gustafsson P. A realistic validation study of a new nitrogen multiple-breath washout system. PLoS One. 2012;7(4):e36083. doi: 10.1371/journal.pone.0036083. Epub 2012 Apr 27.
Related trials for Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruiting
Comparing the Efficacy of a Conversational Agent (QuitBot) Versus Standard Health Education on Smoking Cessation Among Medical Students in Cairo University
Conversational Agent, Smoking Cessation
RecruitingObservational study
§SMOKE Nicotine and Tobacco Youth Cohort
Tobacco Use Behavior, Nicotine Dependence Tobacco Product
Active, not recruitingEarly Phase 1
Smoking Cessation Intervention During Low Dose CT (LDCT) Screening for Lung Cancer
Smoking Cessation
Active, not recruitingPhase 3
Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
Tobacco Dependence
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
Manuela Funke-Chambour, PD Dr. med. principal investigator
Insel Gruppe AG, University Hospital Bern
2 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 Pulmonary Disease, run by University of Bern at 2 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 2 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?
Changes in Lung Clearance Index (LCI) (time frame: Change from baseline to 6 months post quit date). 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 NCT03938298, which also lists 7 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.