OptimAIR: Towards right care in asthma through point-of-care phenotyping, guidelinebased assessment and management optimalisation using the AsthmaOptimiser in primary care (OptimAIR)

Study identification

• EU PAS number:
  EUPAS1000000559
• Study ID:
  1000000559
• Official title and acronym:
  OptimAIR: Towards right care in asthma through point-of-care phenotyping, guidelinebased assessment and management optimalisation using the AsthmaOptimiser in primary care (OptimAIR)
• DARWIN EU® study:
  No
• Study countries:
  Argentina

  Chile

  Spain
• Study description:
  Rationale: Patients with respiratory diseases are mainly treated in primary care, and there remains a need to assess patients’ asthma control, risk, trigger avoidance and inhaler technique, and to ensure that patients are prescribed, and take, appropriate treatments according to the latest (international) guidelines, such as the Global Initiative for Asthma (GINA) guideline. ; Innovative e-health solutions, such as the previously developed AsthmaOptimiser, can guide healthcare professionals through asthma consultations and can facilitate healthcare professionals in optimizing asthma treatment. Structured asthma reviews can also help to uncover opportunities for more personalized management actions. ; OptimAIR will provide insight in the prevalence of (un)controlled asthma and opportunities for management optimalisation, specific disease phenotypes and treatable traits in patients at high risk of exacerbations. In addition, participation in this study might reduce the barrier to participate in further clinical trials.; ; Study design: A prospective study in asthma evaluating point-of-care phenotyping and guidelinebased assessment and management optimalisation using the AsthmaOptimiser in primary care. ; ; Study population: Adult patients with uncontrolled asthma and treated with ICS+LABA. ; ; Study assessment: Each patient will attend a single study visit. During the first part, patient’s current asthma control will be assessed using the ACQ-6 and CAAT, and oscillometry will be performed. In case of uncontrolled asthma and/or abnormal lung function, the patient will continue to the full visit. Patient’s current asthma control and management will be assessed using the AsthmaOptimiser, including spirometry, complemented by FeNO measurement, determination of blood eosinophil (bEOS) counts, and post oscillometry. Following the assessment, both patient and their healthcare provider will receive a report with results of the visit, recommended treatment according to the GINA.;
• Study status:
  Planned

Research institutions and networks

Institutions

General Practitioners Research Institute (GPRI)

Netherlands

Study timelines

Date when funding contract was signed

Actual:03/12/2024

Study start date

Planned:06/05/2025

Data analysis start date

Planned:05/01/2026

Date of final study report

Planned:27/03/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

External Sponsored Collaborative Clinical research sponsored by AstraZeneca BV, ESR-24-22707

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable