Clinical trials / NCT06908421
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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

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…

ClinicalTrials.gov IDNCT06908421
PhaseNot Applicable
Enrollment60
SponsorChiesi Pharma AB, Nordic
Age18 Years and older
SexALL
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Conditions studied

Asthma

About this study

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.

Primary outcomes

Eligibility information

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.

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-23.