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

General Practitioners Research Institute

Status: Active, not recruiting

Conditions: Asthma Control

Treatments: Behavioral: AsthmaOptimiser-supported structured asthma review

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT07390669

EUPAS1000000559 (Other Identifier)

GPRi-2024-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 746 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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746 participants in 1 patient group

OptimAIR structured asthma assessment

Experimental group

Description:

Participants undergo a single structured asthma assessment in primary care using the AsthmaOptimiser with point-of-care phenotyping, followed by remote follow-up questionnaires.

Treatment:

Behavioral: AsthmaOptimiser-supported structured asthma review