Tobacco CessationNCT05764343
The Effect of Immediate Smoking Cessation Interventions for Smokers With Chronic Airway Diseases
A study testing Immediate smoking cessation support in people with Tobacco Cessation and Asthma COPD, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Smoking cessation support is provided by smoking cessation outpatient clinics in our country. Smokers with chronic airway diseases can also apply to these services by making an appointment from quit lines. Quit rates of that group patients were found to be similar to the general population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Cessation, Asthma COPD, Bronchiectasis Adult
- What is being tested?
- Immediate smoking cessation support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 397 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2022to 15 Sep 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being age 18 years and over,
- Having diagnoses of asthma and/or COPD and/or bronchiectasis for at least 6 months,
- Applying to the chest diseases outpatient clinics,
- Being an current smoker,
- Those who agree to participate in the study,
- Patients who can be reached by phone calls at 1 week and 3 months after randomization.
Who cannot join
- Those with active psychiatric disorders
- Patients with impaired cognitive functions.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Recep Tayyip Erdoğan University, Training and Research Hospital
Rize
About this study
Official title: Investigation of the Effectiveness of Immediate Smoking Cessation Interventions During Routine Outpatient Service in Current Smoker Chronic Airway Disease Patients
Smoking cessation support is provided by smoking cessation outpatient clinics in our country. Smokers with chronic airway diseases can also apply to these services by making an appointment from quit lines. Quit rates of that group patients were found to be similar to the general population. In novel smoking cessation support approaches immediate cessation support is reported to be more effective than routine practice. The sample in these studies consists of individuals who applied for lung health screening programmes. There is no study in the literature examining the effect of this immediate support on patients with chronic airway diseases' quit success. Our aim with this study is to examine impact of immediate cessation support by getting an appointment to the same cessation clinic instantly on our sample's cessation success.
Read the detailed description
Patients who are current smokers (who have smoked at least 100 cigarettes in their lifetime and still smoke daily or some days) will be randomized in a 1:1 ratio to the two arms in sequential order of presentation, after they have been identified and given written informed consent about the study. Demographic and clinical features will be filled. A brief smoking cessation intervention will be applied to one group and they will be recommended to apply to smoking cessation outpatient clinics by obtaining appointment from quit lines, as the way of current routine practice. Those randomized to the other group will have an immediate appointment at the smoking cessation outpatient clinic in addition to the brief smoking cessation intervention. Both patient groups will be called after 1 week by phone to inquire about their smoking cessation status and their application to smoking cessation outpatient clinics. Both groups will be called again in the 3rd month and their smoking cessation status, their application to smoking cessation outpatient clinics, and the duration/status of using pharmacological smoking cessation treatments will be questioned.
- Conditions
- Tobacco Cessation, Asthma COPD, Bronchiectasis Adult
- Being tested
- Immediate smoking cessation support
- Keywords
- tobacco cessation, asthma, COPD, bronchiectasis, immediate cessation support
- Medical subject headings
- Tobacco Use Cessation, Asthma, Pulmonary Disease, Chronic Obstructive, Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate smoking cessation supportOther
Smoker patients with chronic airway diseases (asthma and/or COPD and/or bronchiectasis) will be evaluated for the inclusion criteria. Afterwards they will be randomized as routine support arm (as the current procedure of the care) and immediate support arm (intensive brief cessation advices following by the immediate arrangement of the appointment from the same clinic's smoking cessation service). Both arms will be followed remotely at first week and third months of the randomization regarding their quit status as well as their use of evidence based cessation treatments.
| Study group | Role | What they receive |
|---|---|---|
| Routine support/care arm | No intervention | As the followed routine implementation, this group will be given a brief smoking cessation intervention and will be recommended to apply to smoking cessation outpatient clinics by getting an appointment from quit services. |
| Immediate support arm | Active comparator | Those randomized to this group will have an immediate appointment at the smoking cessation outpatient clinic in addition to the brief smoking cessation intervention. Receives: Other: Immediate smoking cessation support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quit rate of both study arms
To compare the quit rate at third month of randomization in the both arms: intensive support arm compared to routine support arm. A quitter will be considered who have never smoked since the target quit day.
Measured: At third month of randomization
Secondary outcomes (1)
Smoking cessation outpatient clinic application rate of both study arms
The admission status to smoking cessation outpatient clinics of both arms will be evaluated: admitted at least once or never admitted.
Measured: At third month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start15 Nov 2022
- Primary completion15 Jun 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Tobacco CessationStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 397 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Turkish Thoracic Society
- Responsible party
- Principal investigator, Dilek KARADOĞAN, Recep Tayyip Erdogan University Training and Research Hospital
- Investigators
- Dilek Karadoğan, Principal investigator, Recep Tayyip Erdogan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764343
- Sponsor's protocol ID
- EKGG
- Status last verified
- Nov 2023
- First submitted
- 11 Feb 2023
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jimenez-Ruiz CA, Andreas S, Lewis KE, Tonnesen P, van Schayck CP, Hajek P, Tonstad S, Dautzenberg B, Fletcher M, Masefield S, Powell P, Hering T, Nardini S, Tonia T, Gratziou C. Statement on smoking cessation in COPD and other pulmonary diseases and in smokers with comorbidities who find it difficult to quit. Eur Respir J. 2015 Jul;46(1):61-79. doi: 10.1183/09031936.00092614. Epub 2015 Apr 16.
PubMed 25882805Karadogan D, Onal O, Kanbay Y. How does reimbursement status affect smoking cessation interventions? A real-life experience from the Eastern Black Sea region of Turkey. Tob Induc Dis. 2019 Jan 22;17:05. doi: 10.18332/tid/100412. eCollection 2019.
PubMed 31582917Williams PJ, Philip KEJ, Gill NK, Flannery D, Buttery S, Bartlett EC, Devaraj A, Kemp SV, Addis J, Derbyshire J, Chen M, Morris K, Laverty AA, Hopkinson NS. Immediate, Remote Smoking Cessation Intervention in Participants Undergoing a Targeted Lung Health Check: Quit Smoking Lung Health Intervention Trial, a Randomized Controlled Trial. Chest. 2023 Feb;163(2):455-463. doi: 10.1016/j.chest.2022.06.048. Epub 2022 Aug 4.
PubMed 35932889Buttery SC, Williams P, Mweseli R, Philip KEJ, Sadaka A, Bartlett EJ, Devaraj A, Kemp S, Addis J, Derbyshire J, Chen M, Morris K, Laverty A, Hopkinson NS. Immediate smoking cessation support versus usual care in smokers attending a targeted lung health check: the QuLIT trial. BMJ Open Respir Res. 2022 Feb;9(1):e001030. doi: 10.1136/bmjresp-2021-001030.
PubMed 35121633Karadogan D, Telatar TG, Kaya I, Atli S, Kabil NK, Marim F, Senel MY, Yuksel A, Yalcin B, Gultekin O, Ercelik M, Akgun M. Immediately scheduled for an appointment to smoking cessation clinics: Key to quitting smoking in chronic airway disease - a multicenter randomized study. Tob Induc Dis. 2025 Jun 5;23. doi: 10.18332/tid/204254. eCollection 2025.
PubMed 40475312
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Immediate Smoking Cessation Interventions During Routine Outpatient Service in Current Smoker Chronic Airway Disease Patients
- ClinicalTrials.gov ID
- NCT05764343
- Acronym / sponsor ID
- EKGG
- Conditions
- Tobacco Cessation, Asthma COPD, Bronchiectasis Adult
- Keywords
- tobacco cessation, asthma, COPD, bronchiectasis, immediate cessation support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 397 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Collaborators
- Turkish Thoracic Society
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 10 Mar 2023 (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.
Smoking cessation support is provided by smoking cessation outpatient clinics in our country. Smokers with chronic airway diseases can also apply to these services by making an appointment from quit lines. Quit rates of that group patients were found to be similar to the general population. In novel smoking cessation support approaches immediate cessation support is reported to be more effective than routine practice. The sample in these studies consists of individuals who applied for lung health screening programmes. There is no study in the literature examining the effect of this immediate support on patients with chronic airway diseases' quit success. Our aim with this study is to examine impact of immediate cessation support by getting an appointment to the same cessation clinic instantly on our sample's cessation success.
Detailed description
Patients who are current smokers (who have smoked at least 100 cigarettes in their lifetime and still smoke daily or some days) will be randomized in a 1:1 ratio to the two arms in sequential order of presentation, after they have been identified and given written informed consent about the study. Demographic and clinical features will be filled. A brief smoking cessation intervention will be applied to one group and they will be recommended to apply to smoking cessation outpatient clinics by obtaining appointment from quit lines, as the way of current routine practice. Those randomized to the other group will have an immediate appointment at the smoking cessation outpatient clinic in addition to the brief smoking cessation intervention. Both patient groups will be called after 1 week by phone to inquire about their smoking cessation status and their application to smoking cessation outpatient clinics. Both groups will be called again in the 3rd month and their smoking cessation status, their application to smoking cessation outpatient clinics, and the duration/status of using pharmacological smoking cessation treatments will be questioned.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine support/care arm | No intervention | –As the followed routine implementation, this group will be given a brief smoking cessation intervention and will be recommended to apply to smoking cessation outpatient clinics by getting an appointment from quit services. |
| Immediate support arm | Active comparator | Other: Immediate smoking cessation supportThose randomized to this group will have an immediate appointment at the smoking cessation outpatient clinic in addition to the brief smoking cessation intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Being age 18 years and over,
- Having diagnoses of asthma and/or COPD and/or bronchiectasis for at least 6 months,
- Applying to the chest diseases outpatient clinics,
- Being an current smoker,
- Those who agree to participate in the study,
Key exclusion criteria (2 listed)
- Those with active psychiatric disorders
- Patients with impaired cognitive functions.
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 |
|---|---|---|
| Immediate smoking cessation supportSmoker patients with chronic airway diseases (asthma and/or COPD and/or bronchiectasis) will be evaluated for the inclusion criteria. Afterwards they will be randomized as routine support arm (as the current procedure of the care) and immediate support arm (intensive brief cessation advices following by the immediate arrangement of the appointment from the same clinic's smoking cessation service). Both arms will be followed remotely at first week and third months of the randomization regarding their quit status as well as their use of evidence based cessation treatments. | Other | Immediate support arm |
Primary outcome
Quit rate of both study arms
Time frame: At third month of randomization
To compare the quit rate at third month of randomization in the both arms: intensive support arm compared to routine support arm. A quitter will be considered who have never smoked since the target quit day.
1 secondary outcome
Smoking cessation outpatient clinic application rate of both study arms
Time frame: At third month
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 24 Nov 2023.
- Results publication: PubMed 25882805Jimenez-Ruiz CA, Andreas S, Lewis KE, Tonnesen P, van Schayck CP, Hajek P, Tonstad S, Dautzenberg B, Fletcher M, Masefield S, Powell P, Hering T, Nardini S, Tonia T, Gratziou C. Statement on smoking cessation in COPD and other pulmonary diseases and in smokers with comorbidities who find it difficult to quit. Eur Respir J. 2015 Jul;46(1):61-79. doi: 10.1183/09031936.00092614. Epub 2015 Apr 16.
- Results publication: PubMed 31582917Karadogan D, Onal O, Kanbay Y. How does reimbursement status affect smoking cessation interventions? A real-life experience from the Eastern Black Sea region of Turkey. Tob Induc Dis. 2019 Jan 22;17:05. doi: 10.18332/tid/100412. eCollection 2019.
- Results publication: PubMed 35932889Williams PJ, Philip KEJ, Gill NK, Flannery D, Buttery S, Bartlett EC, Devaraj A, Kemp SV, Addis J, Derbyshire J, Chen M, Morris K, Laverty AA, Hopkinson NS. Immediate, Remote Smoking Cessation Intervention in Participants Undergoing a Targeted Lung Health Check: Quit Smoking Lung Health Intervention Trial, a Randomized Controlled Trial. Chest. 2023 Feb;163(2):455-463. doi: 10.1016/j.chest.2022.06.048. Epub 2022 Aug 4.
- Results publication: PubMed 35121633Buttery SC, Williams P, Mweseli R, Philip KEJ, Sadaka A, Bartlett EJ, Devaraj A, Kemp S, Addis J, Derbyshire J, Chen M, Morris K, Laverty A, Hopkinson NS. Immediate smoking cessation support versus usual care in smokers attending a targeted lung health check: the QuLIT trial. BMJ Open Respir Res. 2022 Feb;9(1):e001030. doi: 10.1136/bmjresp-2021-001030.
- Derived from this study: PubMed 40475312Karadogan D, Telatar TG, Kaya I, Atli S, Kabil NK, Marim F, Senel MY, Yuksel A, Yalcin B, Gultekin O, Ercelik M, Akgun M. Immediately scheduled for an appointment to smoking cessation clinics: Key to quitting smoking in chronic airway disease - a multicenter randomized study. Tob Induc Dis. 2025 Jun 5;23. doi: 10.18332/tid/204254. eCollection 2025.
- Individual participant dataSharing planned: No
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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.
Dilek Karadoğan principal investigator
Recep Tayyip Erdogan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate smoking cessation support in people with Tobacco Cessation and Asthma COPD, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
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 6 inclusion and 2 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 24 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 1 site in Turkey (Türkiye). 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?
Quit rate of both study arms (time frame: At third month of randomization). 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 NCT05764343, which also lists 5 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 24 Nov 2023.