RecruitingNCT06908421

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.

Sponsor

Chiesi Pharma AB, Nordic

Enrollment

60 participants

Start Date

Sep 15, 2025

Study Type

OBSERVATIONAL

Conditions

Asthma

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 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.

Eligibility

Min Age: 18 Years

Inclusion Criteria10

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 Criteria7

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.