NCT06908421Recruiting
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.
Source: ClinicalTrials.gov · Last updated 5 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 17 Mar 2025
- Start date
- 15 Sept 2025
- Primary completion date
- Sept 2027
- Lead sponsor
- Chiesi Pharma AB, Nordic
- Diseases
- Asthma
- NCT number
- NCT06908421
What you commit to
- Study type: Observational
- Planned participants: 60
- From 15 Sept 2025 to the primary completion date, Sept 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Lung cancer or history of lung cancer.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus | Denmark | Recruiting |
| Copenhagen University Hospital - Hvidovre Coordinator of this site? Confirm its status | Hvidovre | Denmark | Recruiting |
Related publications
- Study protocol: 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.BMC Pulm Med · 2026 · PMID 42414967
This page is information, not medical advice. Discuss any trial with your doctor.