Asthma ControlOptimAIRNCT07390669
OptimAIR: Towards Right Care in Asthma Through Point-of-care Phenotyping, Guideline-based Assessment and Management Optimalisation Using the AsthmaOptimiser in Primary Care
A study testing AsthmaOptimiser-supported structured asthma review in people with Asthma Control, run by General Practitioners Research Institute at 3 sites in 3 countries.
Trial summary
Asthma is mainly managed in primary care, yet disease control remains suboptimal. Many patients experience ongoing symptoms, exacerbations, and frequent short-acting β₂-agonist use, while underestimating the severity of their condition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma Control
- What is being tested?
- AsthmaOptimiser-supported structured asthma review
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 746 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 May 2025to 1 Jul 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Documented physician diagnosis of asthma
- Treated with ICS+LABA
- 1 or more exacerbation(s) requiring oral or systemic corticosteroids for at least 3 days or hospital admission, or emergency room visit within 12 months prior to the OptimAIR study visit
Who cannot join
- Well controlled asthma, defined as ACQ-6 score ≤ 0.75 and normal oscillometry (ALDS result: "normal lung function")
- Not able to understand the patient information sheet and informed consent form
- Other significant respiratory disease than asthma
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Asthma is mainly managed in primary care, yet disease control remains suboptimal. Many patients experience ongoing symptoms, exacerbations, and frequent short-acting β₂-agonist use, while underestimating the severity of their condition. Approximately 40% of patients have uncontrolled asthma based on Asthma Control Questionnaire scores. This highlights the need for structured assessment of asthma control, risk factors, inhaler technique, and alignment of treatment with international guidelines.
Structured asthma reviews and digital support tools may help optimize and personalize asthma management, particularly for patients at increased risk of exacerbations. Novel risk prediction tools using biomarkers such as FeNO and blood eosinophils show promise but are not yet routinely used in primary care.
This study aims to assess asthma control, identify patients at higher risk of exacerbations, and explore opportunities for management optimization in primary care. In addition, it supports the development of a longitudinal respiratory registry to facilitate clinical research and participation in future clinical trials.
Read the detailed description
Patients with respiratory diseases, including asthma, are predominantly managed in primary care, particularly those who have not yet experienced frequent exacerbations. Despite this, asthma control remains suboptimal in a substantial proportion of patients. Ongoing symptoms, exacerbations, and overuse of short-acting β₂-agonists (SABA) are common, and approximately 40% of patients have an Asthma Control Questionnaire (ACQ) score greater than 1.5, indicating uncontrolled asthma. In addition, patients often underestimate the severity of their disease and perceive their asthma as controlled despite persistent symptoms and exacerbations. This creates a gap between perceived and actual disease control and highlights the need for structured assessment and management.
Improved asthma care requires systematic evaluation of asthma control, future risk, trigger avoidance, inhaler technique, and appropriate pharmacological treatment in accordance with current international guidelines, such as those from the Global Initiative for Asthma (GINA). Structured asthma reviews may help identify opportunities for more personalized management and treatment optimization. Digital decision-support tools, such as the previously developed AsthmaOptimiser, can support healthcare professionals during asthma consultations and facilitate guideline-based treatment decisions.
Special attention is warranted for patients at increased risk of poor asthma outcomes, particularly exacerbations. Novel risk prediction tools, including the Oxford asthma attack risk scale (ORACLE), may help identify such patients. The ORACLE score incorporates biomarkers such as fractional exhaled nitric oxide (FeNO) and blood eosinophil counts. However, these biomarkers are not yet routinely assessed in primary care, and further research is needed to evaluate their feasibility, applicability, and added value in this setting.
In parallel, multiple new pharmacological treatment classes for respiratory diseases are under development after decades of limited innovation. The evaluation of these therapies requires large clinical trials with substantial patient participation. As most patients with respiratory diseases are treated in primary care, this setting represents a large potential pool of trial participants who may benefit from participation but are often unaware of available research opportunities.
In this context, the proposed study aims to provide insight into the prevalence of controlled and uncontrolled asthma in primary care, identify opportunities for management optimization, and explore disease phenotypes and treatable traits, particularly in patients at high risk of exacerbations. In addition, the study supports the establishment of the GPRI Respiratory Registry, which will collect up-to-date longitudinal data from patients with respiratory diseases. This registry is intended to facilitate recruitment for future research studies, address relevant scientific questions, and potentially lower barriers for patient participation in clinical trials.
- Conditions
- Asthma Control
- Being tested
- AsthmaOptimiser-supported structured asthma review
- Keywords
- Asthma control, Primary care, ORACLE, FeNO, Oscillometry, ACQ, Blood Eosinophils, Spirometry
- Medical subject headings
- Cardiomyopathy, Dilated, 1C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AsthmaOptimiser-supported structured asthma reviewBehavioural
Participants receive a structured, guideline-based asthma assessment during a single study visit in primary care using the AsthmaOptimiser decision-support tool. The assessment includes patient-reported outcomes (ACQ-6, CAAT), lung function testing (oscillometry and/or spirometry), and point-of-care phenotyping (e.g., FeNO and blood eosinophils, where applicable). Based on these assessments, a report is generated summarizing asthma control, exacerbation risk, and guideline-based opportunities for treatment and management optimization. Treatment decisions remain at the discretion of the treating healthcare professional. Participants complete follow-up questionnaires via a respiratory registry at approximately 3 and 6 months after the visit.
| Study group | Role | What they receive |
|---|---|---|
| OptimAIR structured asthma assessment | Experimental | Participants undergo a single structured asthma assessment in primary care using the AsthmaOptimiser with point-of-care phenotyping, followed by remote follow-up questionnaires. Receives: Behavioral: AsthmaOptimiser-supported structured asthma review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and distribution of identified opportunities for treatment and management optimisation (GINA-guided)
Number and distribution of guideline-based opportunities to optimise asthma treatment and management identified by the AsthmaOptimiser, based on Global Initiative for Asthma (GINA) guidance.
Measured: During the study visit (baseline; single visit)
Secondary outcomes (3)
Management changes following assessment with AsthmaOptimiser and ORACLE
Number and type of management changes following the structured assessment, including:
- Number and type of changes made to inhaled medication
- Number of inhaler device changes based on inhaler technique optimisation
- Number and type of lifestyle recommendations (e.g. smoking cessation)
Measured: From baseline to 12 weeks (follow-up via Respiratory Registry)
Medium-term asthma control after assessment with AsthmaOptimiser
Change from baseline in asthma control and health status assessed by Chronic Airways Assessment Test (CAAT) score, minimum = 0, maximum = 40, higher score means worse health status.
Measured: Baseline and 12 weeks
Medium-term asthma control after assessment with AsthmaOptimiser
Change from baseline in asthma control and health status assessed by Asthma Control Questionnaire-6 (ACQ-6) score, minimum = 0, maximum = 6, higher score means poorer asthma control.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start1 May 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma ControlStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants undergo one structured asthma assessment in primary care using the AsthmaOptimiser with point-of-care phenotyping (e.g., ACQ-6/CAAT, oscillometry/spirometry, FeNO, point-of-care blood eosinophils as applicable). A report with guideline-based management opportunities is provided. Participants then complete remote follow-up questionnaires via the respiratory registry at 3 and 6 months (and ACQ-6/CAAT at \~12 weeks per protocol endpoints).
- Masking
- None (open label)
- Enrolment
- 746 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
- NCT07390669
- Sponsor's protocol ID
- GPRi-2024-004
- Other IDs
- EUPAS1000000559
- Acronym
- OptimAIR
- Status last verified
- Feb 2026
- First submitted
- 15 Jan 2026
- Last updated
- 5 Feb 2026
- 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 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OptimAIR: Towards Right Care in Asthma Through Point-of-care Phenotyping, Guideline-based Assessment and Management Optimalisation Using the AsthmaOptimiser in Primary Care
- ClinicalTrials.gov ID
- NCT07390669
- Acronym / sponsor ID
- OptimAIR / GPRi-2024-004
- Conditions
- Asthma Control
- Keywords
- Asthma control, Primary care, ORACLE, FeNO, Oscillometry, ACQ, Blood Eosinophils, Spirometry
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 746 participants (actual)
- Lead sponsor
- General Practitioners Research InstituteResearch network
- Collaborators
- AstraZeneca
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 5 Feb 2026 (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.
Asthma is mainly managed in primary care, yet disease control remains suboptimal. Many patients experience ongoing symptoms, exacerbations, and frequent short-acting β₂-agonist use, while underestimating the severity of their condition. Approximately 40% of patients have uncontrolled asthma based on Asthma Control Questionnaire scores. This highlights the need for structured assessment of asthma control, risk factors, inhaler technique, and alignment of treatment with international guidelines.
Structured asthma reviews and digital support tools may help optimize and personalize asthma management, particularly for patients at increased risk of exacerbations. Novel risk prediction tools using biomarkers such as FeNO and blood eosinophils show promise but are not yet routinely used in primary care.
This study aims to assess asthma control, identify patients at higher risk of exacerbations, and explore opportunities for management optimization in primary care. In addition, it supports the development of a longitudinal respiratory registry to facilitate clinical research and participation in future clinical trials.
Detailed description
Patients with respiratory diseases, including asthma, are predominantly managed in primary care, particularly those who have not yet experienced frequent exacerbations. Despite this, asthma control remains suboptimal in a substantial proportion of patients. Ongoing symptoms, exacerbations, and overuse of short-acting β₂-agonists (SABA) are common, and approximately 40% of patients have an Asthma Control Questionnaire (ACQ) score greater than 1.5, indicating uncontrolled asthma. In addition, patients often underestimate the severity of their disease and perceive their asthma as controlled despite persistent symptoms and exacerbations. This creates a gap between perceived and actual disease control and highlights the need for structured assessment and management.
Improved asthma care requires systematic evaluation of asthma control, future risk, trigger avoidance, inhaler technique, and appropriate pharmacological treatment in accordance with current international guidelines, such as those from the Global Initiative for Asthma (GINA). Structured asthma reviews may help identify opportunities for more personalized management and treatment optimization. Digital decision-support tools, such as the previously developed AsthmaOptimiser, can support healthcare professionals during asthma consultations and facilitate guideline-based treatment decisions.
Special attention is warranted for patients at increased risk of poor asthma outcomes, particularly exacerbations. Novel risk prediction tools, including the Oxford asthma attack risk scale (ORACLE), may help identify such patients. The ORACLE score incorporates biomarkers such as fractional exhaled nitric oxide (FeNO) and blood eosinophil counts. However, these biomarkers are not yet routinely assessed in primary care, and further research is needed to evaluate their feasibility, applicability, and added value in this setting.
In parallel, multiple new pharmacological treatment classes for respiratory diseases are under development after decades of limited innovation. The evaluation of these therapies requires large clinical trials with substantial patient participation. As most patients with respiratory diseases are treated in primary care, this setting represents a large potential pool of trial participants who may benefit from participation but are often unaware of available research opportunities.
In this context, the proposed study aims to provide insight into the prevalence of controlled and uncontrolled asthma in primary care, identify opportunities for management optimization, and explore disease phenotypes and treatable traits, particularly in patients at high risk of exacerbations. In addition, the study supports the establishment of the GPRI Respiratory Registry, which will collect up-to-date longitudinal data from patients with respiratory diseases. This registry is intended to facilitate recruitment for future research studies, address relevant scientific questions, and potentially lower barriers for patient participation in clinical trials.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants undergo one structured asthma assessment in primary care using the AsthmaOptimiser with point-of-care phenotyping (e.g., ACQ-6/CAAT, oscillometry/spirometry, FeNO, point-of-care blood eosinophils as applicable). A report with guideline-based management opportunities is provided. Participants then complete remote follow-up questionnaires via the respiratory registry at 3 and 6 months (and ACQ-6/CAAT at ~12 weeks per protocol endpoints).
| Arm | Type | Receives |
|---|---|---|
| OptimAIR structured asthma assessment | Experimental | Behavioral: AsthmaOptimiser-supported structured asthma reviewParticipants undergo a single structured asthma assessment in primary care using the AsthmaOptimiser with point-of-care phenotyping, followed by remote follow-up questionnaires. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 years or older
- Documented physician diagnosis of asthma
- Treated with ICS+LABA
- 1 or more exacerbation(s) requiring oral or systemic corticosteroids for at least 3 days or hospital admission, or emergency room visit within 12 months prior to the OptimAIR study visit
Key exclusion criteria (3 listed)
- Well controlled asthma, defined as ACQ-6 score ≤ 0.75 and normal oscillometry (ALDS result: "normal lung function")
- Not able to understand the patient information sheet and informed consent form
- Other significant respiratory disease than asthma
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 |
|---|---|---|
| AsthmaOptimiser-supported structured asthma reviewParticipants receive a structured, guideline-based asthma assessment during a single study visit in primary care using the AsthmaOptimiser decision-support tool. The assessment includes patient-reported outcomes (ACQ-6, CAAT), lung function testing (oscillometry and/or spirometry), and point-of-care phenotyping (e.g., FeNO and blood eosinophils, where applicable). Based on these assessments, a report is generated summarizing asthma control, exacerbation risk, and guideline-based opportunities for treatment and management optimization. Treatment decisions remain at the discretion of the treating healthcare professional. Participants complete follow-up questionnaires via a respiratory registry at approximately 3 and 6 months after the visit. | Behavioural | OptimAIR structured asthma assessment |
Primary outcome
Number and distribution of identified opportunities for treatment and management optimisation (GINA-guided)
Time frame: During the study visit (baseline; single visit)
Number and distribution of guideline-based opportunities to optimise asthma treatment and management identified by the AsthmaOptimiser, based on Global Initiative for Asthma (GINA) guidance.
3 secondary outcomes
Management changes following assessment with AsthmaOptimiser and ORACLE
Time frame: From baseline to 12 weeks (follow-up via Respiratory Registry)
Medium-term asthma control after assessment with AsthmaOptimiser
Time frame: Baseline and 12 weeks
Medium-term asthma control after assessment with AsthmaOptimiser
Time frame: Baseline and 12 weeks
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 5 Feb 2026.
- 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.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AsthmaOptimiser-supported structured asthma review in people with Asthma Control, run by General Practitioners Research Institute at 3 sites in 3 countries.
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 4 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 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Argentina, Chile, Spain. 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?
Number and distribution of identified opportunities for treatment and management optimisation (GINA-guided) (time frame: During the study visit (baseline; single visit)). 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 5 Feb 2026.