Efficacy of a Smart add-on Device in Combination With a Triple Treatment in Asthma Patients on Inhaler Technique and Adherence
Recruiting · NCT06908421 · Observational (researchers observe without assigning treatment) · Lead sponsor: Chiesi Pharma AB, Nordic
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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.
Where it is running
2 locations listed.
- Copenhagen University Hospital-Hvidovre - Hvidovre, Capital Region, Denmark
- Aarhus University Hospital - Aarhus, Central Jutland, Denmark