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

NCT06908421 | Recruiting DMC

• 1 other identifier: 1-10-72-193-23
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Asthma

Keywords

Asthma; Inhaler treatment; smart add-on device; adherence; inhaler technique

Outcome Measures

Primary Outcomes (1)

• To evaluate the impact of the SiA® platform on the level of the type 2 inflammation biomarker FeNO

  To assess the impact of the study on the type 2 biomarker FeNO with a change from baseline of at least 20% will be considered clinically relevant. FeNO values will be presented as ppb. FeNO levels of \< 25 ppb, 25 - 50 ppb, \> 50 ppb, are considered low, medium, and high respectively.

  Change from baseline in FeNO at week 12 and 52.

Secondary Outcomes (8)

• To assess the impact of the SiA® platform on adherence to SITT and inhaler technique measure using the RespiPRO add-on module

  Change in pMDI inhaler technique score and medication adherence score at week 12 and 52 compared to baseline.

• To evaluate the impact of the SiA® platform on asthma control using Asthma Control Test

  Change in ACT scores from baseline at weeks 12 and 52

• To evaluate the impact of the SiA® platform on health-related quality of life

  Change in mini-AQLQ scores from baseline at weeks 12 and 52

• To evaluate the impact of the SiA® platform on lung function measured by spirometry

  From baseline and at week 12 and 52.

• To evaluate the impact of the SiA® platform on shifts in FeNO category

  Change from baseline at week 12 and 52.

Study Arms (1)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chiesi Pharma AB, Nordic: lead
• Briota ApS: collaborator

Study Sites (2)

Copenhagen University Hospital-Hvidovre

Hvidovre, Capital Region, DK-2650, Denmark

RECRUITING

Aarhus University Hospital

Aarhus, Central Jutland, DK-8200 Aarhus N, Denmark

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Johannes M Schmid, PhD, ass. professor

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolai Krogh, PhD

CONTACT

+4526850170; n.krogh@chiesi.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: April 3, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 5, 2025

Record last verified: 2025-09

Locations

DK (2)