Chronic Obstructive Pulmonary Disease (COPD)NCT04119934
Personalized Smoking Cessation Infographic in COPD
An observational study of Chronic Obstructive Pulmonary Disease (COPD) and Smoking Cessation, run by Unity Health Toronto at 1 site in Canada.
Trial summary
This study assesses the effect of a personalized smoking cessation infographic on physician smoking cessation counseling rates and smoking cessation pharmacotherapy prescription rates. The study assesses the difference in physician behaviour using an interrupted time series analysis (one-year pre vs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), Smoking Cessation
- What is being tested?
- Smoking Cessation Intervention Tool
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 83 participants
- Where
- 1 siteCanada
- Study dates
- 9 Jan 2023to 31 Jul 2024
- Phase
- Observational
- 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
Study population: The study population will consist of clinicians in primary care and hospital settings in Toronto, Canada.
Eligible clinicians will include respirologists, general practitioners and nurse practitioners who refer patients for spirometry testing at the St. Michael's Hospital Pulmonary Function Lab.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Personalized Biomedical Risk Assessment for Smoking Cessation in Chronic Obstructive Pulmonary Disease
This study assesses the effect of a personalized smoking cessation infographic on physician smoking cessation counseling rates and smoking cessation pharmacotherapy prescription rates. The study assesses the difference in physician behaviour using an interrupted time series analysis (one-year pre vs. one-year post-intervention). General practitioners, nurse practitioners and respirologists who refer eligible patients (COPD, active smoking) for spirometry at the St. Michael's Hospital Pulmonary Function Lab will receive the infographic. This is a quality improvement initiative.
The smoking cessation infographic uses individualized patient data (height, weight, sex, baseline FEV1, etc.) to produce a personalized lung function decline prediction over the next 15 years.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) affects 11.8% of adult Ontarians, remains the leading cause of hospitalization in Canada, and cost the Canadian economy $770 million in 2010. Smoking cessation reduces mortality and improves quality of life in COPD, and also reduces the risk of developing stroke, coronary heart disease, and several types of cancer. Despite this evidence, 45% of patients with COPD continue to smoke.
Previous trials have demonstrated that even brief smoking cessation advice offered by a physician can increase quit rates, with intensive interventions proving additionally effective. Despite this, only 37% of US and 54% of Canadian smokers who had a visit with a physician during the prior year had been advised to quit smoking. Barriers and enablers underlying this care gap are multi-fold. At the patient level, barriers to quitting include accessibility of appropriate therapy, low expectations of quit success (self-efficacy) and low expectations of risk mitigation by quitting (outcome expectancy). Enablers include easily available therapy, knowledge of ongoing smoking effects, and motivation to quit for personal gain. For clinicians, barriers to providing smoking cessation advice include perceived lack of cessation counseling skills (self-efficacy), lack of time, memory (forgetting to do it), and concerns about harming the doctor-patient relationship. Enablers include reminders to provide cessation advice and improved outcome expectancy (a belief that their patients have a reasonable chance of quitting).
Among different lung function metrics, forced expiratory volume in one second (FEV1) is the best validated metric for quantifying the degree of lung function impairment and is used to define disease severity. Our group previously developed and validated a prediction tool that uses individual patient characteristics to predict a personalized rate of future FEV1 decline. Considering the barriers and enablers to effective smoking cessation interventions noted above, our team then designed a smoking cessation intervention centered on this lung function decline calculator. Given that smoking is a modifiable variable that affects the rate of lung function decline, we translated the original calculator into a clinical infographic which quantitatively demonstrates the consequences of quitting versus continuing smoking on lung function and its correlated patient-relevant outcomes, for each individual patient (i.e. a personalized biomedical risk assessment). This approach was informed by previous studies demonstrating the promise of biomedical risk assessment (the process of giving smokers feedback on the physical effects of smoking using physiological measurements) and tailored educational materials for smoking cessation. Such tools can enhance smoking cessation consultations, particularly when educational material is in a visual format. We first designed a prototype tool according to best infographic design and content evidence and then conducted a series of iterative 2-hour moderated focus groups with 4-5 COPD patient participants per group and semi-structured 1-on-1 interviews with respirologists, until saturation of themes [4 focus groups (20 participants), 4 interviews]. In a rapid cycle design process, we made changes to tool content and format after each focus group and interview, based on qualitative analysis of feedback.
This infographic is designed for clinicians to use as a facilitator for smoking cessation intervention delivery with their patients. It demonstrates expected FEV1 decline with and without smoking cessation, and corresponding patient-relevant morbidities (page 1), and provides clinicians with guidance for smoking cessation pharmacotherapy prescriptions (page 2). With this project, we seek to evaluate this tool in real-world practice to determine implementation feasibility and preliminary impact. The tool will not only act as a prompt for clinicians to provide smoking cessation counseling, but also serves to improve their self-efficacy and to enhance outcome expectancy with respect to smoking cessation advice. In turn, it provides patients with a personalized analysis of the future impact of their smoking and the benefit of a quit, with a goal of enhancing motivation to quit.
- Being tested
- Smoking Cessation Intervention Tool
- Keywords
- Chronic obstructive pulmonary disease, COPD, smoking cessation, smoking
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Smoking Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking Cessation Intervention ToolBehavioural
A personalized smoking cessation infographic is provided to the physician/NP alongside the patient's regular spirometry report.
| Study group | Role | What they receive |
|---|---|---|
| Control - None | A retrospective chart review will assess physician/NP behaviour (rates of smoking cessation counselling and prescription of smoking cessation pharmacotherapy) in the one-year pre-intervention period. | |
| Intervention - Smoking cessation infographic | Throughout the intervention period, the personalized smoking cessation infographic will be provided to physicians/NPs (for eligible patients). Chart review will be conducted for the patient's physician/NP within a three-month window of receiving the infographic to assess outcomes. Receives: Behavioral: Smoking Cessation Intervention Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of eligible, smoking patients with COPD who receive a smoking cessation counselling intervention
Using prospective chart review, we will assess the proportion of smoking patients with COPD who receive or are referred to a smoking cessation intervention at or after the index visit, in each analysis period
Measured: 12 months, broken into individual time series periods
Proportions of eligible, smoking patients with COPD who are prescribed or recommended smoking cessation pharmacotherapy
Using prospective chart review, we will assess the proportion of smoking patients with COPD who are prescribed or recommended smoking cessation pharmacotherapy at or after the index visit, in each analysis period
Measured: 12 months, broken into individual time series periods
Secondary outcomes (8)
Changes in respiratory medication prescriptions for eligible, smoking patients with COPD
Chart review will qualitatively record changes in respiratory medication prescriptions in all visits at or after the index visit, in each analysis period. We will include "on treatment" analyses for relevant outcomes (assessing outcomes in situations where patients a) successfully received the infographic; and b) situations where providers utilized the infographic). We will also analyze and adjust outcomes by provider characteristics (type, site, etc.) if event numbers are sufficient.
Measured: 12 months, broken into individual time series periods
Changes in recommendations for non-pharmacotherapy smoking cessation strategies for eligible, smoking patients with COPD
Chart review will qualitatively record changes in recommendations for non-pharmacotherapy smoking cessation strategies in all visits at or after the index visit, in each analysis period.
Measured: 12 months, broken into individual time series periods
Smoking cessation billing code changes for eligible, smoking patients with COPD.
Chart review will assess billing codes used for smoking cessation in all visits at or after the index visit, in each analysis period. We will include "on treatment" analyses for relevant outcomes (assessing outcomes in situations where patients a) successfully received the infographic; and b) situations where providers utilized the infographic). We will also analyze and adjust outcomes by provider characteristics (type, site, etc.) if event numbers are sufficient.
Measured: 12 months, broken into individual time series periods
Smoking cessation rates for smoking patients with COPD seen a minimum of 6 months after the index visit, in each analysis period.
Chart review will assess for documentation of smoking cessation in all visits at or after the index visit, in each analysis period.
Measured: 6 months
Smoking reduction rates for smoking patients with COPD seen a minimum of 6 months after the index visit, in each analysis period.
Chart review will assess for documentation of smoking reduction in all visits at or after the index visit, in each analysis period. We will include "on treatment" analyses for relevant outcomes (assessing outcomes in situations where patients a) successfully received the infographic; and b) situations where providers utilized the infographic). We will also analyze and adjust outcomes by provider characteristics (type, site, etc.) if event numbers are sufficient.
Measured: 6 months
Changes in number of spirometry referrals for COPD or query COPD (in smokers and non-smokers)
A review of the pulmonary function lab visits in each analysis period will assess whether there was an increase in the number of spirometry referrals from the enrolled physicians, and all physicians.
Measured: 12 months, broken into individual time series periods
Tool uptake
Chart review will look for evidence of tool use with the patient at the visit in all visits at or after the index visit, in the intervention period.
Measured: 12 months
Qualitative and quantitative user feedback for the tool
Exclusively throughout the intervention, electronic questionnaires and telephone interviews will be solicited to assess user feedback on: barriers/enablers to use, feasibility, effect on workflow, perceived usability, quality and impact on smoking cessation counseling delivery and effectiveness.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start9 Jan 2023
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
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 Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119934
- Sponsor's protocol ID
- 19-231
- Status last verified
- Feb 2023
- First submitted
- 7 Oct 2019
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anthonisen NR, Skeans MA, Wise RA, Manfreda J, Kanner RE, Connett JE; Lung Health Study Research Group. The effects of a smoking cessation intervention on 14.5-year mortality: a randomized clinical trial. Ann Intern Med. 2005 Feb 15;142(4):233-9. doi: 10.7326/0003-4819-142-4-200502150-00005.
PubMed 15710956Chapman KR, Bourbeau J, Rance L. The burden of COPD in Canada: results from the Confronting COPD survey. Respir Med. 2003 Mar;97 Suppl C:S23-31. doi: 10.1016/s0954-6111(03)80022-7.
PubMed 12647940Schuster MA, McGlynn EA, Brook RH. How good is the quality of health care in the United States? 1998. Milbank Q. 2005;83(4):843-95. doi: 10.1111/j.1468-0009.2005.00403.x. No abstract available.
PubMed 16279970Zafari Z, Sin DD, Postma DS, Lofdahl CG, Vonk J, Bryan S, Lam S, Tammemagi CM, Khakban R, Man SFP, Tashkin D, Wise RA, Connett JE, McManus B, Ng R, Hollander Z, Sadatsafavi M. Individualized prediction of lung-function decline in chronic obstructive pulmonary disease. CMAJ. 2016 Oct 4;188(14):1004-1011. doi: 10.1503/cmaj.151483. Epub 2016 Aug 2.
PubMed 27486205Voncken-Brewster V, Tange H, de Vries H, Nagykaldi Z, Winkens B, van der Weijden T. A randomized controlled trial evaluating the effectiveness of a web-based, computer-tailored self-management intervention for people with or at risk for COPD. Int J Chron Obstruct Pulmon Dis. 2015 Jun 8;10:1061-73. doi: 10.2147/COPD.S81295. eCollection 2015.
PubMed 26089656Youssef MW, Sukhdeo R, Mogic L, Girdhari RP, Leek E, Sadatsafavi M, Sin DD, Sykes J, Gershon AS, Gupta S. Impact of personalized biomedical risk assessment on smoking cessation counselling in chronic obstructive pulmonary disease. BMC Pulm Med. 2026 Jul 10. doi: 10.1186/s12890-026-04483-w. Online ahead of print.
PubMed 42432647
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Biomedical Risk Assessment for Smoking Cessation in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT04119934
- Acronym / sponsor ID
- 19-231
- Keywords
- Chronic obstructive pulmonary disease, COPD, smoking cessation, smoking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 9 Oct 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 study assesses the effect of a personalized smoking cessation infographic on physician smoking cessation counseling rates and smoking cessation pharmacotherapy prescription rates. The study assesses the difference in physician behaviour using an interrupted time series analysis (one-year pre vs. one-year post-intervention). General practitioners, nurse practitioners and respirologists who refer eligible patients (COPD, active smoking) for spirometry at the St. Michael's Hospital Pulmonary Function Lab will receive the infographic. This is a quality improvement initiative.
The smoking cessation infographic uses individualized patient data (height, weight, sex, baseline FEV1, etc.) to produce a personalized lung function decline prediction over the next 15 years.
Detailed description
Chronic obstructive pulmonary disease (COPD) affects 11.8% of adult Ontarians, remains the leading cause of hospitalization in Canada, and cost the Canadian economy $770 million in 2010. Smoking cessation reduces mortality and improves quality of life in COPD, and also reduces the risk of developing stroke, coronary heart disease, and several types of cancer. Despite this evidence, 45% of patients with COPD continue to smoke.
Previous trials have demonstrated that even brief smoking cessation advice offered by a physician can increase quit rates, with intensive interventions proving additionally effective. Despite this, only 37% of US and 54% of Canadian smokers who had a visit with a physician during the prior year had been advised to quit smoking. Barriers and enablers underlying this care gap are multi-fold. At the patient level, barriers to quitting include accessibility of appropriate therapy, low expectations of quit success (self-efficacy) and low expectations of risk mitigation by quitting (outcome expectancy). Enablers include easily available therapy, knowledge of ongoing smoking effects, and motivation to quit for personal gain. For clinicians, barriers to providing smoking cessation advice include perceived lack of cessation counseling skills (self-efficacy), lack of time, memory (forgetting to do it), and concerns about harming the doctor-patient relationship. Enablers include reminders to provide cessation advice and improved outcome expectancy (a belief that their patients have a reasonable chance of quitting).
Among different lung function metrics, forced expiratory volume in one second (FEV1) is the best validated metric for quantifying the degree of lung function impairment and is used to define disease severity. Our group previously developed and validated a prediction tool that uses individual patient characteristics to predict a personalized rate of future FEV1 decline. Considering the barriers and enablers to effective smoking cessation interventions noted above, our team then designed a smoking cessation intervention centered on this lung function decline calculator. Given that smoking is a modifiable variable that affects the rate of lung function decline, we translated the original calculator into a clinical infographic which quantitatively demonstrates the consequences of quitting versus continuing smoking on lung function and its correlated patient-relevant outcomes, for each individual patient (i.e. a personalized biomedical risk assessment). This approach was informed by previous studies demonstrating the promise of biomedical risk assessment (the process of giving smokers feedback on the physical effects of smoking using physiological measurements) and tailored educational materials for smoking cessation. Such tools can enhance smoking cessation consultations, particularly when educational material is in a visual format. We first designed a prototype tool according to best infographic design and content evidence and then conducted a series of iterative 2-hour moderated focus groups with 4-5 COPD patient participants per group and semi-structured 1-on-1 interviews with respirologists, until saturation of themes [4 focus groups (20 participants), 4 interviews]. In a rapid cycle design process, we made changes to tool content and format after each focus group and interview, based on qualitative analysis of feedback.
This infographic is designed for clinicians to use as a facilitator for smoking cessation intervention delivery with their patients. It demonstrates expected FEV1 decline with and without smoking cessation, and corresponding patient-relevant morbidities (page 1), and provides clinicians with guidance for smoking cessation pharmacotherapy prescriptions (page 2). With this project, we seek to evaluate this tool in real-world practice to determine implementation feasibility and preliminary impact. The tool will not only act as a prompt for clinicians to provide smoking cessation counseling, but also serves to improve their self-efficacy and to enhance outcome expectancy with respect to smoking cessation advice. In turn, it provides patients with a personalized analysis of the future impact of their smoking and the benefit of a quit, with a goal of enhancing motivation to quit.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control - None | – | –A retrospective chart review will assess physician/NP behaviour (rates of smoking cessation counselling and prescription of smoking cessation pharmacotherapy) in the one-year pre-intervention period. |
| Intervention - Smoking cessation infographic | – | Behavioral: Smoking Cessation Intervention ToolThroughout the intervention period, the personalized smoking cessation infographic will be provided to physicians/NPs (for eligible patients). Chart review will be conducted for the patient's physician/NP within a three-month window of receiving the infographic to assess outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of clinicians in primary care and hospital settings in Toronto, Canada.
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 |
|---|---|---|
| Smoking Cessation Intervention ToolA personalized smoking cessation infographic is provided to the physician/NP alongside the patient's regular spirometry report. | Behavioural | Intervention - Smoking cessation infographic |
Primary outcome
Proportion of eligible, smoking patients with COPD who receive a smoking cessation counselling intervention
Time frame: 12 months, broken into individual time series periods
Using prospective chart review, we will assess the proportion of smoking patients with COPD who receive or are referred to a smoking cessation intervention at or after the index visit, in each analysis period
Proportions of eligible, smoking patients with COPD who are prescribed or recommended smoking cessation pharmacotherapy
Time frame: 12 months, broken into individual time series periods
Using prospective chart review, we will assess the proportion of smoking patients with COPD who are prescribed or recommended smoking cessation pharmacotherapy at or after the index visit, in each analysis period
8 secondary outcomes
Changes in respiratory medication prescriptions for eligible, smoking patients with COPD
Time frame: 12 months, broken into individual time series periods
Changes in recommendations for non-pharmacotherapy smoking cessation strategies for eligible, smoking patients with COPD
Time frame: 12 months, broken into individual time series periods
Smoking cessation billing code changes for eligible, smoking patients with COPD.
Time frame: 12 months, broken into individual time series periods
Smoking cessation rates for smoking patients with COPD seen a minimum of 6 months after the index visit, in each analysis period.
Time frame: 6 months
Smoking reduction rates for smoking patients with COPD seen a minimum of 6 months after the index visit, in each analysis period.
Time frame: 6 months
Changes in number of spirometry referrals for COPD or query COPD (in smokers and non-smokers)
Time frame: 12 months, broken into individual time series periods
Tool uptake
Time frame: 12 months
Qualitative and quantitative user feedback for the tool
Time frame: 12 months
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 7 Jul 2026.
- Background: PubMed 15710956Anthonisen NR, Skeans MA, Wise RA, Manfreda J, Kanner RE, Connett JE; Lung Health Study Research Group. The effects of a smoking cessation intervention on 14.5-year mortality: a randomized clinical trial. Ann Intern Med. 2005 Feb 15;142(4):233-9. doi: 10.7326/0003-4819-142-4-200502150-00005.
- Background: PubMed 12647940Chapman KR, Bourbeau J, Rance L. The burden of COPD in Canada: results from the Confronting COPD survey. Respir Med. 2003 Mar;97 Suppl C:S23-31. doi: 10.1016/s0954-6111(03)80022-7.
- Background: PubMed 16279970Schuster MA, McGlynn EA, Brook RH. How good is the quality of health care in the United States? 1998. Milbank Q. 2005;83(4):843-95. doi: 10.1111/j.1468-0009.2005.00403.x. No abstract available.
- Background: PubMed 27486205Zafari Z, Sin DD, Postma DS, Lofdahl CG, Vonk J, Bryan S, Lam S, Tammemagi CM, Khakban R, Man SFP, Tashkin D, Wise RA, Connett JE, McManus B, Ng R, Hollander Z, Sadatsafavi M. Individualized prediction of lung-function decline in chronic obstructive pulmonary disease. CMAJ. 2016 Oct 4;188(14):1004-1011. doi: 10.1503/cmaj.151483. Epub 2016 Aug 2.
- Background: PubMed 26089656Voncken-Brewster V, Tange H, de Vries H, Nagykaldi Z, Winkens B, van der Weijden T. A randomized controlled trial evaluating the effectiveness of a web-based, computer-tailored self-management intervention for people with or at risk for COPD. Int J Chron Obstruct Pulmon Dis. 2015 Jun 8;10:1061-73. doi: 10.2147/COPD.S81295. eCollection 2015.
- Derived from this study: PubMed 42432647Youssef MW, Sukhdeo R, Mogic L, Girdhari RP, Leek E, Sadatsafavi M, Sin DD, Sykes J, Gershon AS, Gupta S. Impact of personalized biomedical risk assessment on smoking cessation counselling in chronic obstructive pulmonary disease. BMC Pulm Med. 2026 Jul 10. doi: 10.1186/s12890-026-04483-w. Online ahead of print.
- Statistics Canada. Canadian Tobacco Use Monitoring Survey (CTUMS): Detailed Information from February to June 2006Link provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease (COPD) and Smoking Cessation, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 7 Jul 2026. 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 Canada. 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?
Proportion of eligible, smoking patients with COPD who receive a smoking cessation counselling intervention (time frame: 12 months, broken into individual time series periods). 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 NCT04119934, 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 7 Jul 2026.