Inhaler Adherence and Inhalation Technique Assessed by a Smart Spacer in Patients With Severe Asthma on Biologics

Comparative analysis of smart spacer medication adherence and inhaler technique against Test of Adherence to Inhalers (TAI-12),Comparison of smart spacer medication adherence patterns (adherence and inhaler technique) with inhaler checklist examined by pulmonologist or pulmonary nurse

Severe refractory asthma affects about 3.5% of asthma patients, often necessitating biologic
 therapy in addition to standard treatment. However, little is understood about maintenance
 and reliever inhalation medication adherence in these cases which might impact overall
 biologic response. Objectively monitoring inhalation medication adherence remains a
 significant challenge. The Smart AeroChamber® device, capable of measuring adherence and
 inhalation technique, is untested in severe asthma patients on biologics, presenting a
 potentially cost-effective solution to monitor adherence and better understand treatment
 response.
 
 This study aims to assess the feasibility of the Smart AeroChamber® device in severe asthma
 patients on biologic therapy, with objectives to:
 
 1. Evaluate inhalation medication adherence patterns and inhaler technique, and comparing
 that adherence data with traditional measures e.g. the Test of Adherence to Inhalers
 (TAI), and an inhalation technique checklist.
 
 2. Investigate the association between inhaled medication adherence and clinical outcomes
 such as exacerbations, short-acting beta-agonists (SABA) use, oral corticosteroids use
 (OCS), Fractional Exhaled Nitric Oxide (FeNO), blood eosinophil count, and Asthma
 Control Questionnaire (ACQ) scores.
 
 3. Assess patient and healthcare provider satisfaction and usability of the Smart
 AeroChamber® device.
 
 The study design is prospective and observational, with a sample size of 110 adult patients
 diagnosed with severe asthma using biologic therapy. Participants will be followed for 12
 months, during which they will receive Smart AeroChamber® devices. These devices will measure
 medication adherence and inhaler technique, and undergo assessments of clinical outcomes at
 regular intervals. Usability and satisfaction will also be evaluated using the Systems
 Usability Scale (SUS) in patients and healthcare professionals.
 
 The study will be conducted across five severe asthma clinics in the Netherlands. Data
 analysis will involve comparing the inhalation medication adherence data with traditional
 measures for adherence and inhalation technique, assessing clinical outcomes, and evaluating
 usability and satisfaction. The findings from this study will provide insights into the
 feasibility and effectiveness of using digital devices like the Smart AeroChamber® to support
 medication adherence and possibly improve outcomes in patients with severe asthma on biologic
 therapy.