Monitoring inhaler use in patients with severe asthma on biologics
Inhaler Adherence and Inhalation Technique Assessed by a Smart Spacer in Patients with Severe Asthma on Biologics
This study is testing a new device to see if it can help track how well people with severe asthma are using their inhalers while on biologic treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen Academic / other |
| Drugs / interventions | omalizumab, mepolizumab, benralizumab, reslizumab, dupilumab, tezepelumab |
| Locations | 5 sites (Zwolle, Overijssel and 4 other locations) |
| Trial ID | NCT06360393 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility of the Smart AeroChamber® device to objectively monitor inhalation medication adherence and technique in patients with severe asthma receiving biologic therapy. It aims to compare adherence patterns obtained from the device with traditional adherence measures, such as the Test of Adherence to Inhalers (TAI) and an inhalation technique checklist. By understanding adherence and technique, the study seeks to improve treatment outcomes for patients with difficult-to-treat asthma. The research addresses a significant gap in knowledge regarding adherence during biologic therapy.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of severe, refractory asthma who are eligible for treatment with specific asthma biologics.
Not a fit: Patients using incompatible inhalers like Symbicort Aerosol or Trixeo Aerosphere, or those who are unable to understand the study language, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved adherence to inhalation medications, enhancing treatment outcomes for patients with severe asthma.
How similar studies have performed: While there is limited data on the use of digital tools for adherence management in severe asthma, the innovative approach of using the Smart AeroChamber® device presents a novel solution that has not been extensively tested in this population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years. * Confirmed asthma diagnoses (≥12% and \>200 ml reversibility in FEV1 or positive histamine/methacholine provocation test or FeNO ≥50) according to the asthma guidelines * Diagnosed with severe, refractory asthma with eligibility for treatment with specific asthma biologics (omalizumab, mepolizumab, benralizumab, reslizumab, dupilumab) * Using medium or high ICS + LABA +/- LAMA+/-SABA) by pMDI+spacer * Willing to sign informed consent Exclusion Criteria: * The use of the Symbicort Aerosol or the Trixeo Aerosphere in combination with a spacer (these inhalers are not compatible with the smart spacer) * Inability to sufficiently understand and read the Dutch language * Current pregnancy * Currently terminally ill
Where this trial is running
Zwolle, Overijssel and 4 other locations
- Isala — Zwolle, Overijssel, Netherlands (Recruiting)
- Medisch Centrum Leeuwarden — Leeuwarden, Provincie Friesland, Netherlands (Recruiting)
- University Medical Center Groningen — Groningen, Provincie Groningen, Netherlands (Recruiting)
- Foundation Martini Hospital — Groningen, Provincie Groningen, Netherlands (Recruiting)
- Stichting Sint Franciscus Vlietland Groep — Rotterdam, South Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Job FM van Boven, PharmD, PhD — University Medical Center Groningen
- Study coordinator: Job FM van Boven, PharmD, PhD
- Email: j.f.m.van.boven@umcg.nl
- Phone: +31 50 361 7893
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.