Smart inhaler cap plus Trimbow to improve inhaler use 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.
We will test whether the SiA smart inhaler cap and app help adults with asthma who use Trimbow pMDI improve their inhaler technique and medication adherence.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chiesi Pharma AB, Nordic Industry-sponsored |
| Locations | 2 sites (Hvidovre, Capital Region and 1 other locations) |
| Trial ID | NCT06908421 on ClinicalTrials.gov |
What this trial studies
This observational study will equip adults with asthma who are already on Trimbow pMDI with the SiA system, which combines a RespiPRO smart inhaler cap and a mobile app to record and give feedback on inhaler use. Participants continue their prescribed Trimbow treatment while the system tracks inhaler technique, timing, and adherence. Key outcomes include changes in inhaler technique, objective adherence metrics, asthma control scores, and airway inflammation measured by FeNO. The study also aims to determine whether persistent inflammation reflects poor adherence/technique or underlying uncontrolled disease that may require therapy escalation, potentially including biologics.
Who should consider this trial
Good fit: Adults (≥18) with a confirmed asthma diagnosis per GINA, FeNO >25 ppb, treated with Trimbow pMDI for >4 weeks, Danish-literate, and owning a compatible Android/iOS smartphone who are comfortable using Bluetooth devices.
Not a fit: Patients without a smartphone or Bluetooth capability, those with COPD or lung cancer, on maintenance systemic corticosteroids or on biologic therapy, or not using Trimbow pMDI are unlikely to benefit or are excluded from this study.
Why it matters
Potential benefit: If successful, the SiA system could improve inhaler technique and adherence, leading to better asthma control, reduced airway inflammation, and clearer identification of patients who may need treatment escalation including biologic therapy.
How similar studies have performed: Previous smart inhaler interventions have reported improved adherence and inhaler technique in some asthma populations, but evidence for this specific SiA/RespiPRO system is limited and primarily observational.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients ≥18 years of age. 2. Objectively verified leading diagnosis of asthma according to GINA 3. FeNO \>25 ppb. 4. Treated with Trimbow 87/5/9 pMDI for \>4 weeks before enrolment, 1. with prescribed rescue medication (SABA). 2. with and without prescription of a spacer. 5. Being literate Danish. 6. Having a personal Android/iOS phone and 4G/5G internet connection. 7. Comfortable using a smart phone and Bluetooth enabled Digital Devices. 8. Willingness to participate in the study, understand the written patient information and being able to provide written informed consent. Exclusion Criteria: 1. 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. 2. Use of systemic corticosteroid as maintenance treatment. 3. Treated with biologics (that is monoclonal antibodies). 4. Concomitant diagnosis of COPD. 5. Lung cancer or history of lung cancer. 6. Respiratory tract infection/exacerbation within 4 weeks prior to enrolment. 7. Use of oral corticosteroids within 4 weeks before enrolment.
Where this trial is running
Hvidovre, Capital Region and 1 other locations
- Copenhagen University Hospital-Hvidovre — Hvidovre, Capital Region, Denmark (Recruiting)
- Aarhus University Hospital — Aarhus, Central Jutland, Denmark (Recruiting)
Study contacts
- Principal investigator: Johannes M Schmid, PhD, ass. professor — Aarhus University Hospital
- Study coordinator: Nicolai Krogh, PhD
- Email: n.krogh@chiesi.com
- Phone: +4526850170
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.