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Efficacy of a Smart add-on Device in Combination With a Triple Treatment in Asthma Patients on Inhaler Technique and Adherence

Recruitingn/aAges 18 Years - anyAllChiesi Pharma AB, Nordic
NCT06908421 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Not listed
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Where

2 sites
Copenhagen University Hospital-Hvidovre
Hvidovre, Denmark
Aarhus University Hospital
Aarhus, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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