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Efficacy of a Smart add-on Device in Combination With a Triple Treatment in Asthma Patients on Inhaler Technique and Adherence
Sponsor: Chiesi Pharma AB, Nordic
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.
Official title: A 52-week, Multicentre, Observational, Prospective Study on the Use of a Smart Platform Connected to a Single-inhaler Triple Therapy (ICS/LABA/LAMA) to Evaluate Effectiveness on Treatment Adherence and Inhaler Technique in Patients With Poorly Controlled Asthma.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
60
Start Date
2025-09-15
Completion Date
2027-09
Last Updated
2025-09-05
Healthy Volunteers
No
Conditions
Locations (2)
Copenhagen University Hospital-Hvidovre
Hvidovre, Capital Region, Denmark
Aarhus University Hospital
Aarhus, Central Jutland, Denmark