Efficacy of a Smart add-on Device in Combination With a Triple Treatment in Asthma Patients on Inhaler Technique and Adherence
Key facts
- Where
- Aarhus and Hvidovre, DenmarkSee the 2 sites
Where in Denmark
- Aarhus University HospitalAarhus, DenmarkTaking people
- Copenhagen University Hospital - HvidovreHvidovre, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chiesi Pharma AB, Nordic
- Trial code
- NCT06908421
- Record updated
- 5 September 2025
- Original description
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.Read full original descriptionShow less
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.
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.
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; Respiratory tract infection/exacerbation within 4 weeks prior to enrolment; Use of oral corticosteroids within 4 weeks before enrolment; Lung cancer or history of lung cancer.