Inhaler Adherence and Inhalation Technique Assessed by a Smart Spacer in Patients with Severe Asthma on Biologics

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
Foundation Martini Hospital
RECRUITING
Groningen
University Medical Center Groningen
RECRUITING
Groningen
Medisch Centrum Leeuwarden
RECRUITING
Leeuwarden
Stichting Sint Franciscus Vlietland Groep
RECRUITING
Rotterdam
Isala
RECRUITING
Zwolle
Contact Information
Primary
Job FM van Boven, PharmD, PhD
j.f.m.van.boven@umcg.nl
+31 50 361 7893
Backup
Amber A Eikholt, MSc
a.a.eikholt@umcg.nl
+31 50 361 7860
Time Frame
Start Date: 2024-05-01
Estimated Completion Date: 2026-06
Participants
Target number of participants: 110
Treatments
Severe asthma patients on biologics
Participants diagnosed with severe asthma using a biologic medication and medium or high dose ICS + LABA with or without LAMA and/or SABA via pMDI and spacer. Participants are being treated at one of the five severe asthma clinics in The Netherlands.
Related Therapeutic Areas
Sponsors
Collaborators: Trudell Medical International
Leads: University Medical Center Groningen

This content was sourced from clinicaltrials.gov