Actively Recruiting
Efficacy of a Smart add-on Device in Combination With a Triple Treatment in Asthma Patients on Inhaler Technique and Adherence
Led by Chiesi Pharma AB, Nordic · Updated on 2025-09-05
60
Participants Needed
2
Research Sites
102 weeks
Total Duration
On this page
Sponsors
C
Chiesi Pharma AB, Nordic
Lead Sponsor
B
Briota ApS
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Efficacy of a Smart add-on Device in Combination With a Triple Treatment in Asthma Patients on Inhaler Technique and Adherence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years of age or older
- Objectively verified leading diagnosis of asthma according to GINA
- FeNO greater than 25 parts per billion
- Treated with Trimbow 87/5/9 pMDI for more than 4 weeks before enrollment
- Prescribed rescue medication (SABA)
- With or without prescription of a spacer
- Literate in Danish
- Own a personal Android or iOS smartphone with 4G/5G internet access
- Comfortable using a smartphone and Bluetooth-enabled digital devices
- Willing to participate, understand the patient information, and provide written informed consent
You will not qualify if you...
- Participation in another clinical trial within 4 weeks prior to enrollment or planned enrollment during the study
- Use of systemic corticosteroids as maintenance treatment
- Treatment with biologic therapies (monoclonal antibodies)
- Diagnosis of chronic obstructive pulmonary disease (COPD)
- Lung cancer or history of lung cancer
- Respiratory tract infection or exacerbation within 4 weeks prior to enrollment
- Use of oral corticosteroids within 4 weeks before enrollment
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Copenhagen University Hospital-Hvidovre
Hvidovre, Capital Region, Denmark, DK-2650
Actively Recruiting
2
Aarhus University Hospital
Aarhus, Central Jutland, Denmark, DK-8200 Aarhus N
Actively Recruiting
Research Team
N
Nicolai Krogh, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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