Smoking CessationESTxENDSNCT04617444
The ESTxENDS Trial- Substudy on Effects of Using Electronic Nicotine Delivery Systems (ENDS) on Olfactory Function
A study testing ENDS (vaporizer/e-cig) and smoking cessation counseling and Smoking cessation counseling in people with Smoking Cessation and Olfactory Disorder, run by University of Bern at 5 sites in Switzerland.
Trial summary
--> This is a substudy of the main ESTxENDS trial (NCT03589989). Olfactory 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, Olfactory Disorder
- 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
- 389 participants
- Where
- 5 sitesSwitzerland
- Study dates
- 7 Sep 2020to 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 Olfactory Function Substudy of ESTxENDS
--> This is a substudy of the main ESTxENDS trial (NCT03589989). Olfactory function outcomes should be considered secondary outcomes of the main smoking cessation outcome formulated in NCT03589989.
Up to one in five people have suffered loss or impairment of their sense of smell, limiting their available information about the environment, including possible hazards (e.g. gas or smoke). An impaired sense of smell is strongly associated with smoking, but its prevalence in smokers has yet to be established. Since only a few prospective cohort studies among smokers have compared change in olfactory function in smokers, it is not known how much or how fast smoking may impair olfactory function. Some studies describe improvement in olfactory function among quitters, supporting anecdotal evidence from ex-smokers who say they regained their sense of smell over time. As far as the investigators know, no randomized controlled trial has tested the effects of a smoking cessation intervention on olfactory function.
Read more
A reliable and validated olfactory function test is the Burghart Sniffin' Sticks 16-item Identification-test, which is quick and easy to administer. 16 familiar odours will be presented to the participants, each for 3-4 seconds. After each odour the participant is asked to select the correct answer from 4 possible answers.
With increasing popularity of e-cigarettes, their effect on the olfactory function also needs to be assessed. It is known, that e-cigarettes produce toxic compounds such as carbonyl and aldehydes, what could impair the sense of smell - especially if the liquid-level is too low or the temperature on the coil is too hot. This is the source of a phenomenon called "dry-hit", which is said to leave a burnt taste or smell to be recognized by users. However, it is unclear if e-cigarettes users with an olfactory dysfunction can adequately recognize a "dry-hit". Therefore, the goal is to investigate the effects of smoking cessation and use of ENDS on olfactory function and the recognition of a "dry-hit" from a test e-cigarette.
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-month period. The primary objective is to assess changes in olfactory function from baseline to 6 months post target quit date (TQD) in cigarette smokers randomized to the intervention group compared to the control group.
- Conditions
- Smoking Cessation, Olfactory Disorder
- Being tested
- ENDS (vaporizer/e-cig) and smoking cessation counseling, Smoking cessation counseling
- Medical subject headings
- Smoking Cessation
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 olfactory function- Baseline
Assessment of olfactory function with the Burghart Sniffin' Sticks 16-item Identification-test. The highest possible score is 16; the cut-off for hyposmia is 11 and cut-off for anosmia is 8.
Measured: Baseline
Assessment of olfactory function- follow-up
Assessment of olfactory function with the Burghart Sniffin' Sticks 16-item Identification-test. The highest possible score is 16; the cut-off for hyposmia is 11 and cut-off for anosmia is 8.
Measured: 6 months post quit date]
Secondary outcomes (2)
Assessment of change of olfactory function
Assessment of change of olfactory function with the Burghart Sniffin' Sticks 16-item Identification-test. The highest possible score is 16; the cut-off for hyposmia is 11 and cut-off for anosmia is 8.
Measured: change from baseline to 6 months post quit date
Assessment of dry-hit recognition
Assessment of dry-hit recognition. Participants will be given 2 ENDS to have them assess the probability of a dry-hit. The participants will be asked to rate the probability of a dry-hit in both ENDS as follows:
- Definitely (3 points)
- Probably (2 points)
- Probably not (1 points)
- Definitely not (0 points) 2 or 3 points will be interpreted as correctly identifying the ENDS generating a dry-hit.
Measured: 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 posted5 Nov 2020
- Study start7 Sep 2020
- 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 (16)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
- 389 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 (BIHAM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04617444
- Sponsor's protocol ID
- 2017-02332j
- Other IDs
- 2017
- Acronym
- ESTxENDS
- Status last verified
- Nov 2023
- First submitted
- 24 Oct 2020
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Whitcroft KL, Hummel T. Clinical Diagnosis and Current Management Strategies for Olfactory Dysfunction: A Review. JAMA Otolaryngol Head Neck Surg. 2019 Sep 1;145(9):846-853. doi: 10.1001/jamaoto.2019.1728.
PubMed 31318413Neuland C, Bitter T, Marschner H, Gudziol H, Guntinas-Lichius O. Health-related and specific olfaction-related quality of life in patients with chronic functional anosmia or severe hyposmia. Laryngoscope. 2011 Apr;121(4):867-72. doi: 10.1002/lary.21387. Epub 2011 Feb 4.
PubMed 21298638Doty RL, Kamath V. The influences of age on olfaction: a review. Front Psychol. 2014 Feb 7;5:20. doi: 10.3389/fpsyg.2014.00020. eCollection 2014.
PubMed 24570664Mullol J, Alobid I, Marino-Sanchez F, Quinto L, de Haro J, Bernal-Sprekelsen M, Valero A, Picado C, Marin C. Furthering the understanding of olfaction, prevalence of loss of smell and risk factors: a population-based survey (OLFACAT study). BMJ Open. 2012 Nov 6;2(6):e001256. doi: 10.1136/bmjopen-2012-001256. Print 2012.
PubMed 23135536Schubert CR, Cruickshanks KJ, Fischer ME, Huang GH, Klein BE, Klein R, Pankow JS, Nondahl DM. Olfactory impairment in an adult population: the Beaver Dam Offspring Study. Chem Senses. 2012 May;37(4):325-34. doi: 10.1093/chemse/bjr102. Epub 2011 Nov 1.
PubMed 22045704Jung HJ, Shin IS, Lee JE. Olfactory function in mild cognitive impairment and Alzheimer's disease: A meta-analysis. Laryngoscope. 2019 Feb;129(2):362-369. doi: 10.1002/lary.27399. Epub 2018 Nov 22.
PubMed 30565695Ajmani GS, Suh HH, Wroblewski KE, Pinto JM. Smoking and olfactory dysfunction: A systematic literature review and meta-analysis. Laryngoscope. 2017 Aug;127(8):1753-1761. doi: 10.1002/lary.26558. Epub 2017 May 31.
PubMed 28561327Frye RE, Schwartz BS, Doty RL. Dose-related effects of cigarette smoking on olfactory function. JAMA. 1990 Mar 2;263(9):1233-6.
PubMed 2304239Siegel JK, Wroblewski KE, McClintock MK, Pinto JM. Olfactory dysfunction persists after smoking cessation and signals increased cardiovascular risk. Int Forum Allergy Rhinol. 2019 Sep;9(9):977-985. doi: 10.1002/alr.22357. Epub 2019 Jul 31.
PubMed 31365791Vennemann MM, Hummel T, Berger K. The association between smoking and smell and taste impairment in the general population. J Neurol. 2008 Aug;255(8):1121-6. doi: 10.1007/s00415-008-0807-9. Epub 2008 Jul 28.
PubMed 18677645Dinc AS, Sengezer T, Cayonu M, Sahin MM. Smoking cessation improves olfactory functions. Laryngoscope. 2020 Feb;130(2):E35-E38. doi: 10.1002/lary.27992. Epub 2019 Apr 5.
PubMed 30953390Hummel T, Kobal G, Gudziol H, Mackay-Sim A. Normative data for the "Sniffin' Sticks" including tests of odor identification, odor discrimination, and olfactory thresholds: an upgrade based on a group of more than 3,000 subjects. Eur Arch Otorhinolaryngol. 2007 Mar;264(3):237-43. doi: 10.1007/s00405-006-0173-0. Epub 2006 Sep 23.
PubMed 17021776Rumeau C, Nguyen DT, Jankowski R. How to assess olfactory performance with the Sniffin' Sticks test((R)). Eur Ann Otorhinolaryngol Head Neck Dis. 2016 Jun;133(3):203-6. doi: 10.1016/j.anorl.2015.08.004. Epub 2015 Sep 4.
PubMed 26344139Farsalinos KE, Gillman G. Carbonyl Emissions in E-cigarette Aerosol: A Systematic Review and Methodological Considerations. Front Physiol. 2018 Jan 11;8:1119. doi: 10.3389/fphys.2017.01119. eCollection 2017.
PubMed 29375395Farsalinos KE, Voudris V, Poulas K. E-cigarettes generate high levels of aldehydes only in 'dry puff' conditions. Addiction. 2015 Aug;110(8):1352-6. doi: 10.1111/add.12942. Epub 2015 May 20.
PubMed 25996087
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 Olfactory Function Substudy of ESTxENDS
- ClinicalTrials.gov ID
- NCT04617444
- Acronym / sponsor ID
- ESTxENDS / 2017-02332j
- Conditions
- Smoking Cessation, Olfactory Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 389 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
- 7 Sep 2020 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 5 Nov 2020 (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). Olfactory function outcomes should be considered secondary outcomes of the main smoking cessation outcome formulated in NCT03589989.
Up to one in five people have suffered loss or impairment of their sense of smell, limiting their available information about the environment, including possible hazards (e.g. gas or smoke). An impaired sense of smell is strongly associated with smoking, but its prevalence in smokers has yet to be established. Since only a few prospective cohort studies among smokers have compared change in olfactory function in smokers, it is not known how much or how fast smoking may impair olfactory function. Some studies describe improvement in olfactory function among quitters, supporting anecdotal evidence from ex-smokers who say they regained their sense of smell over time. As far as the investigators know, no randomized controlled trial has tested the effects of a smoking cessation intervention on olfactory function.
A reliable and validated olfactory function test is the Burghart Sniffin' Sticks 16-item Identification-test, which is quick and easy to administer. 16 familiar odours will be presented to the participants, each for 3-4 seconds. After each odour the participant is asked to select the correct answer from 4 possible answers.
With increasing popularity of e-cigarettes, their effect on the olfactory function also needs to be assessed. It is known, that e-cigarettes produce toxic compounds such as carbonyl and aldehydes, what could impair the sense of smell - especially if the liquid-level is too low or the temperature on the coil is too hot. This is the source of a phenomenon called "dry-hit", which is said to leave a burnt taste or smell to be recognized by users. However, it is unclear if e-cigarettes users with an olfactory dysfunction can adequately recognize a "dry-hit". Therefore, the goal is to investigate the effects of smoking cessation and use of ENDS on olfactory function and the recognition of a "dry-hit" from a test e-cigarette.
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-month period. The primary objective is to assess changes in olfactory function from baseline to 6 months post target quit date (TQD) in cigarette smokers randomized to the intervention group compared to the control group.
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 olfactory function- Baseline
Time frame: Baseline
Assessment of olfactory function with the Burghart Sniffin' Sticks 16-item Identification-test. The highest possible score is 16; the cut-off for hyposmia is 11 and cut-off for anosmia is 8.
Assessment of olfactory function- follow-up
Time frame: 6 months post quit date]
Assessment of olfactory function with the Burghart Sniffin' Sticks 16-item Identification-test. The highest possible score is 16; the cut-off for hyposmia is 11 and cut-off for anosmia is 8.
2 secondary outcomes
Assessment of change of olfactory function
Time frame: change from baseline to 6 months post quit date
Assessment of dry-hit recognition
Time frame: 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 31318413Whitcroft KL, Hummel T. Clinical Diagnosis and Current Management Strategies for Olfactory Dysfunction: A Review. JAMA Otolaryngol Head Neck Surg. 2019 Sep 1;145(9):846-853. doi: 10.1001/jamaoto.2019.1728.
- Background: PubMed 21298638Neuland C, Bitter T, Marschner H, Gudziol H, Guntinas-Lichius O. Health-related and specific olfaction-related quality of life in patients with chronic functional anosmia or severe hyposmia. Laryngoscope. 2011 Apr;121(4):867-72. doi: 10.1002/lary.21387. Epub 2011 Feb 4.
- Background: PubMed 24570664Doty RL, Kamath V. The influences of age on olfaction: a review. Front Psychol. 2014 Feb 7;5:20. doi: 10.3389/fpsyg.2014.00020. eCollection 2014.
- Background: PubMed 23135536Mullol J, Alobid I, Marino-Sanchez F, Quinto L, de Haro J, Bernal-Sprekelsen M, Valero A, Picado C, Marin C. Furthering the understanding of olfaction, prevalence of loss of smell and risk factors: a population-based survey (OLFACAT study). BMJ Open. 2012 Nov 6;2(6):e001256. doi: 10.1136/bmjopen-2012-001256. Print 2012.
- Background: PubMed 22045704Schubert CR, Cruickshanks KJ, Fischer ME, Huang GH, Klein BE, Klein R, Pankow JS, Nondahl DM. Olfactory impairment in an adult population: the Beaver Dam Offspring Study. Chem Senses. 2012 May;37(4):325-34. doi: 10.1093/chemse/bjr102. Epub 2011 Nov 1.
- Background: PubMed 30565695Jung HJ, Shin IS, Lee JE. Olfactory function in mild cognitive impairment and Alzheimer's disease: A meta-analysis. Laryngoscope. 2019 Feb;129(2):362-369. doi: 10.1002/lary.27399. Epub 2018 Nov 22.
- Background: PubMed 28561327Ajmani GS, Suh HH, Wroblewski KE, Pinto JM. Smoking and olfactory dysfunction: A systematic literature review and meta-analysis. Laryngoscope. 2017 Aug;127(8):1753-1761. doi: 10.1002/lary.26558. Epub 2017 May 31.
- Background: PubMed 2304239Frye RE, Schwartz BS, Doty RL. Dose-related effects of cigarette smoking on olfactory function. JAMA. 1990 Mar 2;263(9):1233-6.
- Background: PubMed 31365791Siegel JK, Wroblewski KE, McClintock MK, Pinto JM. Olfactory dysfunction persists after smoking cessation and signals increased cardiovascular risk. Int Forum Allergy Rhinol. 2019 Sep;9(9):977-985. doi: 10.1002/alr.22357. Epub 2019 Jul 31.
- Background: PubMed 18677645Vennemann MM, Hummel T, Berger K. The association between smoking and smell and taste impairment in the general population. J Neurol. 2008 Aug;255(8):1121-6. doi: 10.1007/s00415-008-0807-9. Epub 2008 Jul 28.
- Background: PubMed 30953390Dinc AS, Sengezer T, Cayonu M, Sahin MM. Smoking cessation improves olfactory functions. Laryngoscope. 2020 Feb;130(2):E35-E38. doi: 10.1002/lary.27992. Epub 2019 Apr 5.
- Background: PubMed 17021776Hummel T, Kobal G, Gudziol H, Mackay-Sim A. Normative data for the "Sniffin' Sticks" including tests of odor identification, odor discrimination, and olfactory thresholds: an upgrade based on a group of more than 3,000 subjects. Eur Arch Otorhinolaryngol. 2007 Mar;264(3):237-43. doi: 10.1007/s00405-006-0173-0. Epub 2006 Sep 23.
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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 (BIHAM)
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 Olfactory Disorder, 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 olfactory function- Baseline (time frame: Baseline). The study lists 2 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 NCT04617444, which also lists 16 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; AzTrials last refreshed its copy on 6 Nov 2026.