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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

NCT06908421 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2025-09-05

No results posted yet for this 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.

Conditions

Sponsors & Collaborators

  • Briota ApS

    collaborator UNKNOWN

  • Chiesi Pharma AB, Nordic

    lead INDUSTRY

Principal Investigators

  • Johannes M Schmid, PhD, ass. professor · Aarhus University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2027-09-30
Completion
2027-09-30

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06908421 on ClinicalTrials.gov