RecruitingNCT06908421

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

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.


Sponsor

Chiesi Pharma AB, Nordic

Enrollment

60 participants

Start Date

Sep 15, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a smart digital sensor to an inhaler device helps people with asthma use their inhaler more correctly and stick to their treatment plan better. **You may be eligible if...** - You are 18 or older - You have a confirmed asthma diagnosis - You have elevated airway inflammation markers (FeNO >25 ppb) - You have been using a specific triple-combination inhaler (Trimbow) for more than 4 weeks - You own an Android or iOS smartphone with 4G/5G internet - You are comfortable using a smartphone and Bluetooth devices - You read and understand Danish **You may NOT be eligible if...** - You have participated in another clinical trial in the last 4 weeks or plan to during the study - You do not meet the inhaler usage or technology requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(2)

Copenhagen University Hospital-Hvidovre

Hvidovre, Capital Region, Denmark

Aarhus University Hospital

Aarhus, Central Jutland, Denmark

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NCT06908421


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