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.

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Denmark
Aarhus University Hospital
RECRUITING
Aarhus
Copenhagen University Hospital-Hvidovre
RECRUITING
Hvidovre
Contact Information
Primary
Nicolai Krogh, PhD
n.krogh@chiesi.com
+4526850170
Time Frame
Start Date: 2025-09-15
Estimated Completion Date: 2027-09
Participants
Target number of participants: 60
Treatments
Study population
Asthma patients above 18 years of age, with objectively verified diagnosis of asthma according to GINA, uncontrolled T2 inflammation (FeNO \>25ppm) on BDP/FF/G inhalation treatment with prescribed rescue medication (SABA).
Related Therapeutic Areas
Sponsors
Collaborators: Briota ApS
Leads: Chiesi Pharma AB, Nordic

This content was sourced from clinicaltrials.gov