NCT06360393 Inhaler Adherence and Inhalation Technique Assessed by a Smart Spacer in Patients with Severe Asthma on Biologics
| NCT ID | NCT06360393 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Medical Center Groningen |
| Condition | Asthma |
| Study Type | OBSERVATIONAL |
| Enrollment | 110 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 110 participants in total. It began in 2024-05-01 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Severe refractory asthma affects about 3.5% of asthma patients, often necessitating biologic therapy in addition to standard treatment. However, little is understood about maintenance and reliever inhalation medication adherence in these cases which might impact overall biologic response. Objectively monitoring inhalation medication adherence remains a significant challenge. The Smart AeroChamber® device, capable of measuring adherence and inhalation technique, is untested in severe asthma patients on biologics, presenting a potentially cost-effective solution to monitor adherence and better understand treatment response. This study aims to assess the feasibility of the Smart AeroChamber® device in severe asthma patients on biologic therapy, with objectives to: 1. Evaluate inhalation medication adherence patterns and inhaler technique, and comparing that adherence data with traditional measures e.g. the Test of Adherence to Inhalers (TAI), and an inhalation technique checklist. 2. Investigate the association between inhaled medication adherence and clinical outcomes such as exacerbations, short-acting beta-agonists (SABA) use, oral corticosteroids use (OCS), Fractional Exhaled Nitric Oxide (FeNO), blood eosinophil count, and Asthma Control Questionnaire (ACQ) scores. 3. Assess patient and healthcare provider satisfaction and usability of the Smart AeroChamber® device. The study design is prospective and observational, with a sample size of 110 adult patients diagnosed with severe asthma using biologic therapy. Participants will be followed for 12 months, during which they will receive Smart AeroChamber® devices. These devices will measure medication adherence and inhaler technique, and undergo assessments of clinical outcomes at regular intervals. Usability and satisfaction will also be evaluated using the Systems Usability Scale (SUS) in patients and healthcare professionals. The study will be conducted across five severe asthma clinics in the Netherlands. Data analysis will involve comparing the inhalation medication adherence data with traditional measures for adherence and inhalation technique, assessing clinical outcomes, and evaluating usability and satisfaction. The findings from this study will provide insights into the feasibility and effectiveness of using digital devices like the Smart AeroChamber® to support medication adherence and possibly improve outcomes in patients with severe asthma on biologic therapy.
Eligibility 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
Contact & Investigator
Job FM van Boven, PharmD, PhD
PRINCIPAL INVESTIGATOR
University Medical Center Groningen
Frequently Asked Questions
Who can join the NCT06360393 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Asthma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06360393 currently recruiting?
Yes, NCT06360393 is actively recruiting participants. Contact the research team at j.f.m.van.boven@umcg.nl for enrollment information.
Where is the NCT06360393 trial being conducted?
This trial is being conducted at Zwolle, Netherlands, Leeuwarden, Netherlands, Groningen, Netherlands, Groningen, Netherlands and 1 additional location.
Who is sponsoring the NCT06360393 clinical trial?
NCT06360393 is sponsored by University Medical Center Groningen. The principal investigator is Job FM van Boven, PharmD, PhD at University Medical Center Groningen. The trial plans to enroll 110 participants.
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