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

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Evaluating point-of-care phenotyping and guideline-based assessment and management optimalisation
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Asthma

Population studied

• Short description of the study population:
  Adult patients with uncontrolled asthma and treated with ICS+LABA
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  700

Study design details

• Study design:
  The OptimAIR study is a prospective study in asthma evaluating point-of-care phenotyping and; guideline-based assessment and management optimalisation using the AsthmaOptimiser.
• Main study objective:
  Primary Objective: ; Assess the level of asthma control and opportunities for management improvement using the AsthmaOptimiser tool in Argentina, Chile and Spain.; ; Secondary objectives:; - Gain insights into management changes following the use of AsthmaOptimiser and Oxford asthma attack risk scale (ORACLE) score; - Determine impact of assessment with AsthmaOptimiser on medium term asthma control; ; Exploratory objectives:; - Assess the population risk for future exacerbation according to the ORACLE score; - Assess impact OptimAIR participation in engagement with clinical trials
• Setting:
  Patients will be recruited via primary care.; Each patient will attend a single study visit. This visit can be short or full-length, depending on; asthma control and lung function. ; ; Short visit:; During the short visit, patient’s current asthma control and status will be assessed using the ACQ-6; and CAAT, and oscillometry will be performed. Based on the outcome of the short visit there are two; options:; 1. Well controlled asthma, defined as ACQ-6 score ≤ 0.75 and normal oscillometry (ALDS result: “normal lung function”). The visit is finished. The patient will receive follow-up questionnaires via the Respiratory registry after 3 and 6 months.; 2. Uncontrolled asthma, defined as ACQ-6 score > 0.75 OR abnormal lungfunction based on; the ALDS report. The patient will continue with the full visit.; ; Full visit:; During the full visit, patient’s current asthma control and management will be assessed using the; AsthmaOptimiser, including spirometry, complemented by Fraction exhaled nitric oxide (FeNO); measurement, determination of blood eosinophil (bEOS) counts using point-of-care measurements,; 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 guidance; and future risk according to the ORACLE score. Patients and, where approved by the patient,; treating clinicians receive a list of studies being conducted in their region which the patient might be; eligible for.; Patient follow-up will be conducted after 3 and 6 months using the Respiratory Registry. The; patients will receive an online invitation to fill in a digital questionnaire including questions regarding; their exacerbations during the past 3 months, potential changes in medication use and the CAAT; questionnaire.
• Outcomes:
  Primary objective:; Number and distribution of identified opportunities for treatment and management optimisation (based on Global; Initiative for Asthma (GINA) guidance); ; Secondary objectives:; • Number and type of changes made to inhaled medication; • Number of changes of inhaler device made based upon technique optimisation; • Number and type of recommendations made to lifestyle changes (eg smoking cessation); ; • Change from baseline in CAAT score after 12 weeks; • Change from baseline in ACQ-6 score after 12 weeks; ; Exploratory objectives; • Distribution of ORACLE risk score; • Number of patients identified based on ICS use, lung function and biomarkers that would be eligible for non-ICS treatment in clinical trials; • Willingness to participate in interventional clinical trials when approached through OptimAIR visit; • Change in CAAT score in patients eligible and participating in clinical trials versus patients eligible but not participating in clinical trials after 6 months
• Data analysis plan:
  Mainly descriptive statistics will be used to present the results of the study