AsthmaNCT04456270
Asthma Control in a Dutch Primary Care Population
An observational study of Asthma and Asthma; Eosinophilic, run by General Practitioners Research Institute at 1 site in Netherlands.
Trial summary
Rationale: Despite the availability of effective treatment to reach symptom control, nearly half of the asthma patients remain inadequately controlled. There is a need for timely and appropriate treatment of patients with uncontrolled asthma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma, Asthma; Eosinophilic, Asthma Chronic
- How many people
- 222 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Oct 2020to 1 Mar 2022
- 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
- Adult, Older adult
Study population: Primary care patients with a current asthma diagnosis, who are scheduled to have in-person asthma review consultations with a primary care nurse, will be recruited from primary care practices located in the northern part of the Netherlands. The population includes men and women ≥18 years of age with clinically diagnosed asthma. The diagnosis of asthma is allowed to be a clinical diagnosis rendered by a doctor, 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
- Aged ≥ 18 years
- Physician diagnosis of Asthma
- Capacity to provide written informed consent
Who cannot join
- Life expectancy of less than 1 year
- Inability to understand Dutch
- Any other condition which, at the GPs and/or investigator's discretion, is believed to present a safety risk or may impact the study results
- Patients participating in a clinical trial that may distort outcomes in this observational study.
Trial locations and contacts
1 site in 1 country.
About this study
Rationale: Despite the availability of effective treatment to reach symptom control, nearly half of the asthma patients remain inadequately controlled. There is a need for timely and appropriate treatment of patients with uncontrolled asthma. Improving asthma control could be achieved by a better identification of causes followed by remediating modifiable factors in primary care or referral to secondary care. However, major gaps in evidence-based asthma practice exist in primary care. So far, there is a lack of knowledge on the prevalence of inadequate asthma and associated characteristics.
Objective: The primary objective is to determine the proportion of primary care patients with inadequate asthma control, as assessed during a regular control consultation with the general practice nurse.
Read more
Study design: This is a non-interventional prospective observational study, taking place in a real-world primary care setting. The AsthmaOptimiser tool will be used during regular asthma consultations in primary care, which the healthcare provider will fill in together with the patient. The AsthmaOptimiser tool creates an overview of factors and characteristics that may be associated with uncontrolled asthma, and subsequently provides a guideline-based management suggestion. Additionally, we will perform qualitative interviews to collect experiences and perspectives of healthcare providers on their use of the AsthmaOptimiser tool, including, but not limited to, ease of use, points of improvement, and on their implementation of the management suggestions.
Study population: Patients diagnosed with asthma, who attend a pre-planned primary care asthma review, 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.
Main study parameters/endpoints: The primary endpoint is the proportion of patients with inadequate asthma control. Inadequate asthma control will be defined as an exacerbation in the past 4 weeks and/or an ACQ6 (i.e., Asthma Control Questionnaire) score >0.75.
- Conditions
- Asthma, Asthma; Eosinophilic, Asthma Chronic, Asthma; Status
- Medical subject headings
- Asthma, Pulmonary Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Primary care patients with current asthma | Male and female primary care patients aged ≥18 years of age with clinically diagnosed asthma. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control Questionnaire
self-reported assessment of asthma symptoms
Measured: week prior to visit to general practice nurse for check-up appointment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start1 Oct 2020
- Primary completion1 Dec 2021
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Prospective
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Practitioners Research Institute
- Sponsor type
- Research network
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Janwillem Kocks, PhD, Principal investigator, General Practitioners Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456270
- Sponsor's protocol ID
- GPRI19103
- Status last verified
- May 2024
- First submitted
- 29 Jun 2020
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asthma Control in a Dutch Primary Care Population
- ClinicalTrials.gov ID
- NCT04456270
- Acronym / sponsor ID
- GPRI19103
- Conditions
- Asthma, Asthma; Eosinophilic, Asthma Chronic, Asthma; Status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- General Practitioners Research InstituteResearch network
- Collaborators
- AstraZeneca
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 2 Jul 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.
Rationale: Despite the availability of effective treatment to reach symptom control, nearly half of the asthma patients remain inadequately controlled. There is a need for timely and appropriate treatment of patients with uncontrolled asthma. Improving asthma control could be achieved by a better identification of causes followed by remediating modifiable factors in primary care or referral to secondary care. However, major gaps in evidence-based asthma practice exist in primary care. So far, there is a lack of knowledge on the prevalence of inadequate asthma and associated characteristics.
Objective: The primary objective is to determine the proportion of primary care patients with inadequate asthma control, as assessed during a regular control consultation with the general practice nurse.
Study design: This is a non-interventional prospective observational study, taking place in a real-world primary care setting. The AsthmaOptimiser tool will be used during regular asthma consultations in primary care, which the healthcare provider will fill in together with the patient. The AsthmaOptimiser tool creates an overview of factors and characteristics that may be associated with uncontrolled asthma, and subsequently provides a guideline-based management suggestion. Additionally, we will perform qualitative interviews to collect experiences and perspectives of healthcare providers on their use of the AsthmaOptimiser tool, including, but not limited to, ease of use, points of improvement, and on their implementation of the management suggestions.
Study population: Patients diagnosed with asthma, who attend a pre-planned primary care asthma review, 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.
Main study parameters/endpoints: The primary endpoint is the proportion of patients with inadequate asthma control. Inadequate asthma control will be defined as an exacerbation in the past 4 weeks and/or an ACQ6 (i.e., Asthma Control Questionnaire) score >0.75.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary care patients with current asthma | – | –Male and female primary care patients aged ≥18 years of age with clinically diagnosed asthma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Primary care patients with a current asthma diagnosis, who are scheduled to have in-person asthma review consultations with a primary care nurse, will be recruited from primary care practices located in the northern part of the Netherlands. The population includes men and women ≥18 years of age with clinically diagnosed asthma. The diagnosis of asthma is allowed to be a clinical diagnosis rendered by a doctor, 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 (3 listed)
- Aged ≥ 18 years
- Physician diagnosis of Asthma
- Capacity to provide written informed consent
Key exclusion criteria (4 listed)
- Life expectancy of less than 1 year
- Inability to understand Dutch
- Any other condition which, at the GPs and/or investigator's discretion, is believed to present a safety risk or may impact the study results
- Patients participating in a clinical trial that may distort outcomes in this observational study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Asthma Control Questionnaire
Time frame: week prior to visit to general practice nurse for check-up appointment
self-reported assessment of asthma symptoms
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 14 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
Janwillem Kocks, PhD principal investigator
General Practitioners Research Institute
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 Asthma and Asthma; Eosinophilic, run by General Practitioners Research Institute at 1 site 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 3 inclusion and 4 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 14 May 2024. 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 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?
Asthma Control Questionnaire (time frame: week prior to visit to general practice nurse for check-up appointment). 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 14 May 2024.