COPDNCT06659666
The COPD Optimiser
An observational study of COPD, run by General Practitioners Research Institute at 2 sites in Netherlands.
Trial summary
Rationale: The Global Initiative for Chronic Obstructive Lung Disease (GOLD) report pro- vides clinical treatment guidelines for COPD aimed at relieving and reducing the impact of symptoms, and reducing the risk of adverse health events, such as exacerbations. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- COPD
- What is being tested?
- COPD Optimiser
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 2 sitesNetherlands
- Study dates
- 9 Oct 2024to 24 Jul 2025
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care patients with a current COPD diagnosis who visit the GP team for their COPD are eligible to participate in the study. Patients with COPD will be recruited from 10-15 primary care practices in the Netherlands. The population includes men and women ≥35 years of age with clinically diagnosed COPD. The diagnosis of COPD is allowed to be a clinical diagnosis rendered by a member of the GP team, without the requirement to conduct additional confirmatory testing. Furthermore, a limited number of in- and exclusion criteria will be adopted, to make sure the research population closely resembles the real world.
Who may be able to join
- Physician diagnosis of COPD (ICPC R95),
- Capacity to understand and provide written informed consent.
Who cannot join
- Active diagnosis of Asthma (ICPC R96)
- Patients participating in an interventional clinical trial
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
General practices in Netherlands
Groningen, Provincie Groningen, 9713GH
GPRI
Groningen, Provincie Groningen, 9713GH
About this study
Official title: Opportunities to Optimize COPD Management Using the COPD Optimiser Online Tool in Dutch General Practice
Rationale: The Global Initiative for Chronic Obstructive Lung Disease (GOLD) report pro- vides clinical treatment guidelines for COPD aimed at relieving and reducing the impact of symptoms, and reducing the risk of adverse health events, such as exacerbations. Despite the availability of these COPD treatment guidelines, evidence suggests that available thera- pies may not be utilized to their full potential to optimize disease management and outcomes for patients. So far, there is a lack of knowledge on the optimalisation opportunities of patients with COPD in a primary care setting.
Objective: The primary objective is to describe the GOLD-guided management suggestions obtained from the COPD Optimiser, in order to gain insight into optimalisation opportunities in a Dutch primary care population of patients with COPD.
Read more
Study design: This is a non-interventional prospective observational study, taking place in a real-world primary care setting.
Study population: Patients diagnosed with COPD are eligible to participate. A limited number of in- and exclusion criteria will be adopted, to make sure the research population closely resembles the real world.
ature and extent of the burden and risks associated with participation, benefit and group relatedness: Study specific involvement is limited to the one visit for the participant. Participants will receive enhanced usual medical care as determined by their physician and will not be randomly allocated to an experimental intervention or care as usual. The partici- pating general practices and participants in the study will be reimbursed for the time spent on this study. Risks of participating in the study are deemed to be negligible. All participants will use their own medication and follow the management plan that is in line with guidelines. The study specific additions to the consultation are administering a (not emotionally demanding) questionnaire and drawing a small amount of blood from the finger, to measure the level of blood eosinophils, using a point-of-care method. This is a test that may cause a slight incon- venience for the patient, although this test is less invasive than typical blood draws that would be part of the newest international guideline.
Primary objective
- Describe the GOLD-guided management suggestions obtained from the COPD Optimiser, in order to gain insight into optimalisation opportunities in a Dutch primary care pop- ulation of patients with COPD. The endpoint for the primary objective is the number of times that each manage- ment suggestion was given
- Conditions
- COPD
- Being tested
- COPD Optimiser
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COPD OptimiserDevice
Patients will receive enhanced usual medical care as determined by their physician. The study visit is a standard consultation supported by the COPD Optimiser webtool. The extra elements added to the COPD consultation are the use of the COPD Optimiser and a short questionnaire directly following the consultation on the patient's experience with the COPD Optimiser. Patients can additionally consent to two optional elements: 1) a determination of blood eosinophil count using a point of care test and 2) a brief interview on their experience with the COPD Optimiser. this tool creates an overview of fac- tors and characteristics that may be associated with suboptimal COPD and provides GOLD guideline-based management suggestions. Implementation of the COPD Optimiser will sup- port healthcare professionals in providing optimal care for their COPD patients by providing individualized GOLD-guided management suggestions.
| Study group | Role | What they receive |
|---|---|---|
| Usual care COPD consultation with the COPD Optimiser | Primary care patients with a current COPD diagnosis who visit the GP team for their COPD are eligible to participate in the study. Patients with COPD will be recruited from 10-15 primary care practices in the Netherlands. The population includes men and women ≥35 years of age with clinically diagnosed COPD. The diagnosis of COPD is allowed to be a clinical diagnosis rendered by a member of the GP team, without the requirement to conduct additional confirm- atory testing. Furthermore, a limited number of in- and exclusion criteria will be adopted, to make sure the research population closely resembles the real world. Receives: Device: COPD Optimiser |
What is being measured
The primary outcome is the main question the study is designed to answer.
patterns of co-occurrence of GOLD-guided management suggestions in a Dutch primary care population of patients with COPD.
The primary endpoint is the number of times that each management suggestion was given. With this endpoint, we can describe the proportion of primary care patients with COPD of whom disease management can be optimized per GOLD-guided management suggestions from the COPD Optimiser. Incidence will be described for each of the possible management suggestions from the COPD Optimiser.
Measured: Immediately after the procedure
Secondary outcomes (1)
Co-occurance and concordance of GOLD-based management suggestions
The secondary study endpoints are
- The presence of co-occurring GOLD-guided management suggestions from the COPD Optimiser in primary care patients with COPD
- The proportion of patients for whom the current medication regimen is not in line with the GOLD pharmacological treatment recommendation, either:
- The proportion of patients that received a GOLD-guided step-up advice from the COPD Optimiser
- The proportion of patients that received a GOLD-guided step-down advice from the COPD optimiser
Measured: Immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start9 Oct 2024
- Primary completion20 Jan 2025
- Study completion24 Jul 2025
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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Practitioners Research Institute
- Sponsor type
- Research network
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06659666
- Sponsor's protocol ID
- GPRI_2024_003
- Status last verified
- Dec 2025
- First submitted
- 22 Oct 2024
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This is currently under review
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opportunities to Optimize COPD Management Using the COPD Optimiser Online Tool in Dutch General Practice
- ClinicalTrials.gov ID
- NCT06659666
- Acronym / sponsor ID
- GPRI_2024_003
- Conditions
- COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- General Practitioners Research InstituteResearch network
- Collaborators
- AstraZeneca
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 24 Jul 2025 (actual)
- First posted
- 26 Oct 2024 (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.
Rationale: The Global Initiative for Chronic Obstructive Lung Disease (GOLD) report pro- vides clinical treatment guidelines for COPD aimed at relieving and reducing the impact of symptoms, and reducing the risk of adverse health events, such as exacerbations. Despite the availability of these COPD treatment guidelines, evidence suggests that available thera- pies may not be utilized to their full potential to optimize disease management and outcomes for patients. So far, there is a lack of knowledge on the optimalisation opportunities of patients with COPD in a primary care setting.
Objective: The primary objective is to describe the GOLD-guided management suggestions obtained from the COPD Optimiser, in order to gain insight into optimalisation opportunities in a Dutch primary care population of patients with COPD.
Study design: This is a non-interventional prospective observational study, taking place in a real-world primary care setting.
Study population: Patients diagnosed with COPD are eligible to participate. A limited number of in- and exclusion criteria will be adopted, to make sure the research population closely resembles the real world.
ature and extent of the burden and risks associated with participation, benefit and group relatedness: Study specific involvement is limited to the one visit for the participant. Participants will receive enhanced usual medical care as determined by their physician and will not be randomly allocated to an experimental intervention or care as usual. The partici- pating general practices and participants in the study will be reimbursed for the time spent on this study. Risks of participating in the study are deemed to be negligible. All participants will use their own medication and follow the management plan that is in line with guidelines. The study specific additions to the consultation are administering a (not emotionally demanding) questionnaire and drawing a small amount of blood from the finger, to measure the level of blood eosinophils, using a point-of-care method. This is a test that may cause a slight incon- venience for the patient, although this test is less invasive than typical blood draws that would be part of the newest international guideline.
Primary objective
- Describe the GOLD-guided management suggestions obtained from the COPD Optimiser, in order to gain insight into optimalisation opportunities in a Dutch primary care pop- ulation of patients with COPD. The endpoint for the primary objective is the number of times that each manage- ment suggestion was given
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Usual care COPD consultation with the COPD Optimiser | – | Device: COPD OptimiserPrimary care patients with a current COPD diagnosis who visit the GP team for their COPD are eligible to participate in the study. Patients with COPD will be recruited from 10-15 primary care practices in the Netherlands. The population includes men and women ≥35 years of age with clinically diagnosed COPD. The diagnosis of COPD is allowed to be a clinical diagnosis rendered by a member of the GP team, without the requirement to conduct additional confirm- atory testing. Furthermore, a limited number of in- and exclusion criteria will be adopted, to make sure the research population closely resembles the real world. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care patients with a current COPD diagnosis who visit the GP team for their COPD are eligible to participate in the study. Patients with COPD will be recruited from 10-15 primary care practices in the Netherlands. The population includes men and women ≥35 years of age with clinically diagnosed COPD. The diagnosis of COPD is allowed to be a clinical diagnosis rendered by a member of the GP team, without the requirement to conduct additional confirmatory testing. Furthermore, a limited number of in- and exclusion criteria will be adopted, to make sure the research population closely resembles the real world.
Key inclusion criteria (2 listed)
- Physician diagnosis of COPD (ICPC R95),
- Capacity to understand and provide written informed consent.
Key exclusion criteria (2 listed)
- Active diagnosis of Asthma (ICPC R96)
- Patients participating in an interventional clinical trial
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 |
|---|---|---|
| COPD OptimiserPatients will receive enhanced usual medical care as determined by their physician. The study visit is a standard consultation supported by the COPD Optimiser webtool. The extra elements added to the COPD consultation are the use of the COPD Optimiser and a short questionnaire directly following the consultation on the patient's experience with the COPD Optimiser. Patients can additionally consent to two optional elements: 1) a determination of blood eosinophil count using a point of care test and 2) a brief interview on their experience with the COPD Optimiser. this tool creates an overview of fac- tors and characteristics that may be associated with suboptimal COPD and provides GOLD guideline-based management suggestions. Implementation of the COPD Optimiser will sup- port healthcare professionals in providing optimal care for their COPD patients by providing individualized GOLD-guided management suggestions. | Device | Usual care COPD consultation with the COPD Optimiser |
Primary outcome
patterns of co-occurrence of GOLD-guided management suggestions in a Dutch primary care population of patients with COPD.
Time frame: Immediately after the procedure
The primary endpoint is the number of times that each management suggestion was given. With this endpoint, we can describe the proportion of primary care patients with COPD of whom disease management can be optimized per GOLD-guided management suggestions from the COPD Optimiser. Incidence will be described for each of the possible management suggestions from the COPD Optimiser.
1 secondary outcome
Co-occurance and concordance of GOLD-based management suggestions
Time frame: Immediately after the procedure
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 26 Dec 2025.
- 2024 GOLD Report - Global Initiative for Chronic Obstructive Lung Disease - GOLD. Ac- cessed July 19, 2024. https://goldcopd.org/2024-gold-report/Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. This is currently under review
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by General Practitioners Research Institute at 2 sites in Netherlands.
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 2 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 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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?
patterns of co-occurrence of GOLD-guided management suggestions in a Dutch primary care population of patients with COPD. (time frame: Immediately after the procedure). 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 26 Dec 2025.