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

Condition(s) studied

Study summary

The goal of this observational study is to determine if using the SiA® (Systematic Intervention Agent) system can improve inhaler technique and medication adherence in adults with asthma who are already using Trimbow pMDI inhalers. Furthermore, it will be addressed if the SiA® system can be used to discriminate between patients, where increased inflammatory markers are 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.

The main questions it aims to answer are:

* Can the SiA® system improve inhaler use and medication adherence in asthma patients?
* Does improving inhaler technique and adherence lead to better asthma control and reduced airway inflammation (measured by FeNO levels)?

Participants will:

* Use the SiA® system, which includes a smart inhaler cap (RespiPRO™) and a mobile app
* Continue their prescribed Trimbow pMDI treatment for asthma.
* Have their asthma control, lung function, and FeNO levels monitored at specific points over 1 year (3 months and 12 months).

The study does not have a comparison group and all results will be compared to baseline.

Eligibility

Primary outcome measure(s)

• To evaluate the impact of the SiA® platform on the level of the type 2 inflammation biomarker FeNO — Change from baseline in FeNO at week 12 and 52.
  To assess the impact of the study on the type 2 biomarker FeNO with a change from baseline of at least 20% will be considered clinically relevant. FeNO values will be presented as ppb. FeNO levels of \< 25 ppb, 25 - 50 ppb, \> 50 ppb, are considered low, medium, and high respectively.

Trial sites (2)

Other trials for the same condition