OptimAIR: Towards Right Care in Asthma Through Point-of-care Phenotyping, Guideline-based Assessment and Management Optimalisation Using the AsthmaOptimiser in Primary Care

NCT07390669 | Active Not Recruiting

• 2 other identifiers: GPRi-2024-004EUPAS1000000559
• Study Type: interventional
• Target: 746
• Locations: 3 countries
• Sites: 3

Brief 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. 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.

Conditions

Asthma Control

Keywords

Asthma control; Primary care; ORACLE; FeNO; Oscillometry; ACQ; Blood Eosinophils; Spirometry

Outcome Measures

Primary Outcomes (1)

• 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.

  During the study visit (baseline; single visit)

Secondary Outcomes (3)

• Management changes following assessment with AsthmaOptimiser and ORACLE

  From baseline to 12 weeks (follow-up via Respiratory Registry)

• Medium-term asthma control after assessment with AsthmaOptimiser

  Baseline and 12 weeks

• Medium-term asthma control after assessment with AsthmaOptimiser

  Baseline and 12 weeks

Other Outcomes (4)

• Population risk for future exacerbations according to ORACLE

  During the study visit (baseline; full visit participants)

• Willingness to participate in future interventional clinical trials following an OptimAIR visit

  Baseline + 3-months follow-up questionnaire

• Impact of OptimAIR participation on engagement with clinical trials

  12 weeks

Study Arms (1)

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.

Behavioral: AsthmaOptimiser-supported structured asthma review

Interventions

AsthmaOptimiser-supported structured asthma review BEHAVIORAL

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.

OptimAIR structured asthma assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older
• Documented physician diagnosis of asthma
• Treated with ICS+LABA
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• General Practitioners Research Institute: lead
• AstraZeneca: collaborator

Study Sites (3)

Multiple primary care sites

Buenos Aires, Argentina

Location

Multiple primary care sites

Santiago, Chile

Location

Multiple primary care sites

Palma de Mallorca, Spain

Location

MeSH Terms

Conditions

Cardiomyopathy, Dilated, 1C

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: February 5, 2026
• Study Start: May 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); AR (1); CL (1)