Status:
RECRUITING
Efficacy of a Smart add-on Device in Combination With a Triple Treatment in Asthma Patients on Inhaler Technique and Adherence
Lead Sponsor:
Chiesi Pharma AB, Nordic
Collaborating Sponsors:
Briota ApS
Conditions:
Asthma
Eligibility:
All Genders
18+ years
Brief 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 alrea...
Detailed Description
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 adheren...
Eligibility Criteria
Inclusion
- Patients ≥18 years of age.
- Objectively verified leading diagnosis of asthma according to GINA
- FeNO \>25 ppb.
- Treated with Trimbow 87/5/9 pMDI for \>4 weeks before enrolment,
- with prescribed rescue medication (SABA).
- with and without prescription of a spacer.
- Being literate Danish.
- Having a personal Android/iOS phone and 4G/5G internet connection.
- Comfortable using a smart phone and Bluetooth enabled Digital Devices.
- Willingness to participate in the study, understand the written patient information and being able to provide written informed consent.
Exclusion
- Participation in a clinical trial within 4 weeks prior to enrolment into the present study or planned enrolment in a clinical trial during the observational period.
- Use of systemic corticosteroid as maintenance treatment.
- Treated with biologics (that is monoclonal antibodies).
- Concomitant diagnosis of COPD.
- Lung cancer or history of lung cancer.
- Respiratory tract infection/exacerbation within 4 weeks prior to enrolment.
- Use of oral corticosteroids within 4 weeks before enrolment.
Key Trial Info
Start Date :
September 15 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06908421
Start Date
September 15 2025
End Date
September 1 2027
Last Update
September 5 2025
Active Locations (2)
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1
Copenhagen University Hospital-Hvidovre
Hvidovre, Capital Region, Denmark, DK-2650
2
Aarhus University Hospital
Aarhus, Central Jutland, Denmark, DK-8200 Aarhus N