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Clinical Trials in Spain / NCT07390669
Active, not recruiting Not applicable

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

NCT07390669 · tracked via the Priya Life Science Spain tracker
Sponsor
General Practitioners Research Institute
Phase
Not applicable
Started
2025-05-01
Last updated
2026-02-05

Condition(s) studied

Asthma Control

Investigational drug(s) / intervention(s)

AsthmaOptimiser-supported structured asthma review

AsthmaOptimiser-supported structured asthma review: 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Multiple primary care sites Buenos Aires Argentina
Multiple primary care sites Santiago Chile
Multiple primary care sites Palma de Mallorca Spain

More General Practitioners Research Institute trials in Spain

"Breathlessness Diagnostics in a Box" (BiaB) for Primary Care. A Multi-country Quality Improvement Project Using a Randomized Stepped-wedge Design Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07390669 on ClinicalTrials.gov ↗ ← All trials in Spain