COPDQLC+NCT05444062
Quebec Lung Cancer Screening PLUS Trial
A study testing Educational material and treatment recommendations for patients, general practitioners and pharmacists in people with COPD and Coronary Artery Calcification, run by Nicole Ezer, MD, FRCPC, MPH at 1 site in Canada.
Trial summary
Does an educational intervention for untreated COPD and cardiovascular disease which is integrated in an existing lung cancer screening program improve guideline concordant medication adherence at 12 months Read more about this study
- Who is it for?
- Ages 55 to 74 years
- Conditions the study is for
- COPD, Coronary Artery Calcification
- What is being tested?
- Educational material and treatment recommendations for patients, general practitioners and pharmacists
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteCanada
- Study dates
- 23 Apr 2023to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient screened for lung cancer as part of the Quebec Lung Cancer Demonstration project by low dose CT scan of the chest.
- Cardiovascular aim: mild to severe CAC identified on low dose CT, not on guideline recommended lipid-lowering therapy.
- COPD aim: diagnosed with COPD, symptomatic (mMRC >=1 or CAT>= 10) and untreated, or not on first line guideline recommended therapy for COPD.
Who cannot join
- Any participant with a high suspicion of lung cancer, defined as Lung-RADS (Lung Imaging Reporting and Data System) 3 or 4, as this is an inopportune time to initiate new medical therapies.
- Cardiovascular aim: Absent CAC, known clinical atherosclerosis, known former heart surgery, Diabetes Mellitus.
- COPD aim: asymptomatic, or already on appropriate first line COPD therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quebec Lung Cancer Screening PLUS Trial - a Randomized Controlled Trial of an Educational Intervention for Untreated Chronic Obstructive Pulmonary Disease (COPD) and/or Cardiovascular Disease (CVD) Identified During Lung Cancer Screening
Does an educational intervention for untreated COPD and cardiovascular disease which is integrated in an existing lung cancer screening program improve guideline concordant medication adherence at 12 months
- Conditions
- COPD, Coronary Artery Calcification
- Being tested
- Educational material and treatment recommendations for patients, general practitioners and pharmacists
- Keywords
- COPD, Coronary Artery Calcification, Lung cancer screening, Undiagnosed disease, Educational intervention, Medication adherence, Untreated disease, Statins, Inhalers
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Undiagnosed Diseases, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational material and treatment recommendations for patients, general practitioners and pharmacistsBehavioural
Educational material and treatment recommendations given to patients, their family doctors and their pharmacists.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm: CVD | No intervention | Patients diagnosed with mild to severe CAC and not on first line guideline recommended therapy. Coronary artery Calcification (CAC) score obtained from lung cancer screening CT Scan images |
| Intervention Arm: CVD | Other | Patients diagnosed with mild to severe CAC and not on first line guideline recommended therapy.
CAC score obtained from lung cancer screening CT Scan images Receives: Behavioral: Educational material and treatment recommendations for patients, general practitioners and pharmacists |
| Control Arm: COPD | No intervention | Patients with untreated COPD or not on first line guideline recommended therapy. |
| Intervention Arm: COPD | Other | Patients with untreated COPD or not on first line guideline recommended therapy. Receives: Behavioral: Educational material and treatment recommendations for patients, general practitioners and pharmacists |
What is being measured
The primary outcome is the main question the study is designed to answer.
Guideline concordant statin therapy 1 year following the first low dose CT scan.
Among patients with moderate to severe coronary artery calcifications (CAC) not on a statin at baseline, any statin prescribed for primary prevention at least once in the 1 year following the first low dose CT scan.
(aim 1)
Measured: 1 year post CT
Guideline concordant inhaler therapy 1 year following the first low dose CT scan
Among patients who have untreated or inappropriately treated COPD at baseline, any long acting muscarinic antagonist inhaler prescribed at least once in the 1 year following the first low dose CT scan (aim 2)
Measured: 1 year post CT
Secondary outcomes (8)
Medication possession ratio (MPR) - Aim 1
Reflects patient adherence. Days of drug supply over 1 year with cholesterol lowering medication in the previous 1 year from pharmacy dispensation records.
Measured: 1 year post CT
Medication possession ratio (MPR) - Aim 2
Reflects patient adherence. Days of drug supply over 1 year with guideline concordant inhaler therapy for COPD in the previous 1 year from pharmacy dispensation records.
Measured: 1 year post CT
COPD Symptoms
COPD Assessment Test is a validated patient-reported outcome. It measures 8 symptoms of COPD on a 0-5 point scale at baseline, 6 and 12 months post intervention
Measured: Baseline, 6 months post intervention, 12 months post intervention
Quality of life using SF-36 questionnaire
SF-36 questionnaire will be filled at baseline and 12 months post intervention
Measured: Baseline, 12 months post intervention
Patient satisfaction with communication and decision making
COMRADE is a 20-item self-reported measure for use in primary care to assess risk communication and confidence in treatment decision making. It assesses patient satisfaction with information provided about risks/benefits of treatment, perception of participation in treatment decisions, and satisfaction with that decision.
COMRADE questionnaire will be sent to patients after their first meeting with their general practitioner up to 3 months after intervention.
Measured: 3 months post intervention
Health Care Utilisation
Number of unplanned clinic visits, hospitalizations for respiratory or cardiac disease, consultations with specialists (cardiology and respirology), invasive/non-invasive cardiac or respiratory investigations
Measured: 1 year post intervention
Absenteeism and presenteeism
Work productivity and activity impairment (WPAI) questionnaire
Measured: baseline
Health literacy
Health literacy will be assessed at study entry using the Brief Health Literacy Screen.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start23 Apr 2023
- Primary completionFeb 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nicole Ezer, MD, FRCPC, MPH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nicole Ezer, MD, FRCPC, MPH, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05444062
- Sponsor's protocol ID
- MP-37-2023-8641
- Acronym
- QLC+
- Status last verified
- Aug 2025
- First submitted
- 27 Jun 2022
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quebec Lung Cancer Screening PLUS Trial - a Randomized Controlled Trial of an Educational Intervention for Untreated Chronic Obstructive Pulmonary Disease (COPD) and/or Cardiovascular Disease (CVD) Identified During Lung Cancer Screening
- ClinicalTrials.gov ID
- NCT05444062
- Acronym / sponsor ID
- QLC+ / MP-37-2023-8641
- Conditions
- COPD, Coronary Artery Calcification
- Keywords
- COPD, Coronary Artery Calcification, Lung cancer screening, Undiagnosed disease, Educational intervention, Medication adherence, Untreated disease, Statins
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Nicole Ezer, MD, FRCPC, MPHUniversity, hospital or other
- Study start
- 23 Apr 2023 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 5 Jul 2022 (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.
Does an educational intervention for untreated COPD and cardiovascular disease which is integrated in an existing lung cancer screening program improve guideline concordant medication adherence at 12 months
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Arm: CVD | No intervention | –Patients diagnosed with mild to severe CAC and not on first line guideline recommended therapy. Coronary artery Calcification (CAC) score obtained from lung cancer screening CT Scan images |
| Intervention Arm: CVD | Other | Behavioral: Educational material and treatment recommendations for patients, general practitioners and pharmacistsPatients diagnosed with mild to severe CAC and not on first line guideline recommended therapy. CAC score obtained from lung cancer screening CT Scan images |
| Control Arm: COPD | No intervention | –Patients with untreated COPD or not on first line guideline recommended therapy. |
| Intervention Arm: COPD | Other | Behavioral: Educational material and treatment recommendations for patients, general practitioners and pharmacistsPatients with untreated COPD or not on first line guideline recommended therapy. |
Who may qualify
- Ages
- 55 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient screened for lung cancer as part of the Quebec Lung Cancer Demonstration project by low dose CT scan of the chest.
- Cardiovascular aim: mild to severe CAC identified on low dose CT, not on guideline recommended lipid-lowering therapy.
- COPD aim: diagnosed with COPD, symptomatic (mMRC >=1 or CAT>= 10) and untreated, or not on first line guideline recommended therapy for COPD.
Key exclusion criteria (3 listed)
- Any participant with a high suspicion of lung cancer, defined as Lung-RADS (Lung Imaging Reporting and Data System) 3 or 4, as this is an inopportune time to initiate new medical therapies.
- Cardiovascular aim: Absent CAC, known clinical atherosclerosis, known former heart surgery, Diabetes Mellitus.
- COPD aim: asymptomatic, or already on appropriate first line COPD therapy.
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 |
|---|---|---|
| Educational material and treatment recommendations for patients, general practitioners and pharmacistsEducational material and treatment recommendations given to patients, their family doctors and their pharmacists. | Behavioural | Intervention Arm: COPD, Intervention Arm: CVD |
Primary outcome
Guideline concordant statin therapy 1 year following the first low dose CT scan.
Time frame: 1 year post CT
Among patients with moderate to severe coronary artery calcifications (CAC) not on a statin at baseline, any statin prescribed for primary prevention at least once in the 1 year following the first low dose CT scan. (aim 1)
Guideline concordant inhaler therapy 1 year following the first low dose CT scan
Time frame: 1 year post CT
Among patients who have untreated or inappropriately treated COPD at baseline, any long acting muscarinic antagonist inhaler prescribed at least once in the 1 year following the first low dose CT scan (aim 2)
8 secondary outcomes
Medication possession ratio (MPR) - Aim 1
Time frame: 1 year post CT
Medication possession ratio (MPR) - Aim 2
Time frame: 1 year post CT
COPD Symptoms
Time frame: Baseline, 6 months post intervention, 12 months post intervention
Quality of life using SF-36 questionnaire
Time frame: Baseline, 12 months post intervention
Patient satisfaction with communication and decision making
Time frame: 3 months post intervention
Health Care Utilisation
Time frame: 1 year post intervention
Absenteeism and presenteeism
Time frame: baseline
Health literacy
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 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.
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?
A study testing Educational material and treatment recommendations for patients, general practitioners and pharmacists in people with COPD and Coronary Artery Calcification, run by Nicole Ezer, MD, FRCPC, MPH 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?
The sponsor lists 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Guideline concordant statin therapy 1 year following the first low dose CT scan. (time frame: 1 year post CT). 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?
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 11 Aug 2025.