Efficacy of a Smart add-on Device in Combination With a Triple Treatment in Asthma Patients on Inhaler Technique and Adherence

Background and Rationale Asthma is a chronic inflammatory disease of the airways that affects millions of individuals worldwide. Despite the availability of effective inhaled medications, poor adherence and incorrect inhaler technique remain major barriers to optimal asthma control. Studies show that up to 86.7% of asthma patients make at least one inhaler technique error, and 30-40% demonstrate poor adherence to their prescribed medication. These factors contribute to worsened symptoms, increased healthcare utilization, and reduced quality of life.

The SiA® system, developed by Briota ApS, aims to address these challenges by integrating a smart inhaler cap (RespiPRO™) with a mobile application. This system provides real-time feedback on inhaler technique and adherence, allowing patients and healthcare providers to track progress and make necessary adjustments.

This study seeks to determine whether using the SiA® system alongside a pressurized metered dose inhaler (pMDI) therapy can lead to measurable improvements in medication adherence, inhalation technique, and asthma control. Furthermore, it will be addressed if the SiA® system can be used to discriminate between patients, where increased inflammatory markers are caused by inadequate treatment caused by incorrect inhaler technique/adherence to medication or patients that have ongoing inflammation requiring adjustment of therapy. Potentially those who might become candidate for biological treatments.

Study Design This is a prospective, single-arm observational study conducted at two hospitals in Denmark. It is designed to assess how the SiA® System impacts inhaler technique and medication adherence over a 12-month period.

Key Features of the Study Design:

* Observational (non-interventional): Participants will continue their standard asthma medication (Trimbow pMDI) but will use the SiA® system to monitor their inhaler technique and adherence. * Single-arm design: All participants will receive the SiA® System - there is no comparison group. * Real-world setting: The study aims to reflect how patients interact with the SiA® system in everyday life, outside of a controlled clinical trial environment.

Study Setting:

* Conducted at two specialized respiratory clinics in Denmark. * Participants will be recruited from routine asthma care visits.

Data Collection Methods:

Data will be collected through multiple sources:

* Hospital medical records (to gather historical asthma data and prior exacerbation history). * Spirometry tests (to assess lung function). * FeNO tests (to measure airway inflammation). * SiA® System data (to track inhaler adherence and technique). * Patient-reported outcome measures (questionnaires on asthma symptoms and quality of life).

Technology Used in the Study:

* RespiPRO™ Smart Inhaler Cap: A device that attaches to Trimbow pMDI and records inhaler usage data. * SiA® Mobile App: Tracks daily inhaler use, provides feedback, and sends adherence reminders.

Study Timeline:

Total Study Duration: 22 months, with individual patient follow-up lasting 12 months (52 weeks).

Patient Flow and Study Visits:

1. Screening and Baseline Visit (Week 0) - Study Enrolment

* Patients will be identified during routine asthma care visits and screened for eligibility. * Informed consent will be obtained. * Baseline data collection will include: * Medical history * Asthma severity and medication use * Spirometry test (lung function) * FeNO test (airway inflammation) * ACT (Asthma Control Test) and mini-AQLQ (Asthma Quality of Life Questionnaire) * Patients will receive a brief training session on how to use the SiA® System. * A baseline inhaler technique video will be recorded using the SiA® Mobile App. 2. Interim Follow-up Visit (Week 12) - Progress Check

* Patients will return for an in-person visit. * Repeat measurements:

* FeNO test (to check inflammation levels). * Spirometry (lung function test). * ACT and mini-AQLQ (patient-reported outcomes). * Adherence data from the SiA® system will be reviewed. * Patients will complete a satisfaction survey about their experience with the SiA® system. 3. Final Study Visit (Week 52) - End of Study

* Repeat FeNO, spirometry, ACT, and mini-AQLQ assessments. * The final inhaler technique video will be recorded and analyzed. * Patients will return or deactivate the RespiPRO™ Smart Inhaler Cap. * Final adherence and inhalation technique data will be collected from the SiA® Dashboard.

Potential Impact of the Study

This study aims to generate real-world evidence on how digital health interventions can improve asthma management. If successful, the SiA® System could:

* Enhance asthma control by ensuring patients use their inhalers correctly. * Reduce unnecessary medication escalation, preventing overuse of corticosteroids. * Lower healthcare costs by reducing asthma-related hospital visits. * Empower patients with real-time feedback and better self-management tools. * Improve and optimize the way asthma patients become candidate for biological treatments

• To assess the impact of the SiA® platform on adherence to SITT and inhaler technique measure using the RespiPRO add-on module [Срок оценки: Change in pMDI inhaler technique score and medication adherence score at week 12 and 52 compared to baseline.]
• To evaluate the impact of the SiA® platform on asthma control using Asthma Control Test [Срок оценки: Change in ACT scores from baseline at weeks 12 and 52]
• To evaluate the impact of the SiA® platform on health-related quality of life [Срок оценки: Change in mini-AQLQ scores from baseline at weeks 12 and 52]
• To evaluate the impact of the SiA® platform on lung function measured by spirometry [Срок оценки: From baseline and at week 12 and 52.]
• To evaluate the impact of the SiA® platform on shifts in FeNO category [Срок оценки: Change from baseline at week 12 and 52.]
• To evaluate the impact of the SiA® platform on annualized exacerbations rates [Срок оценки: Change in annualized exacerbation rates (moderate and severe) from baseline at week 52]
• o evaluate the impact of the SiA® platform on the use of rescue medication (SABA) [Срок оценки: Change from baseline (first 7 days after entering the study) in the use of rescue medication (SABA) at week 12 and 52).]
• Satisfaction and compliance with add-on device based on a customized survey [Срок оценки: at week 52.]