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Expertise Asthma COPD Program with Digital Support
Sponsor: Franciscus Gasthuis
Summary
The aim EXACT@Home is to create an evidence-based health program using e.g. questionnaires, a digital health platform and multiple digital devices to further improve the assessment of patients diagnosed with severe asthma. By better charting treatable traits (e.g. poor adherence, physical inactivity, dysfunctional breathing), we expect to improve the indication for the use of biologics. One the devices that will be used is also a medicinal product: a digital inhaler, which monitors adherence and inhaler technique through its connected application and aims to improve adherence and inhaler technique with reminders and notifications. Next to this an activity tracker, hand-held spirometer and FeNO measuring device will be used. The information of the devices will be collected in a Personal Digital Healthcare Environment (PDHE). Patients diagnosed with severe asthma according to the regional asthma Multi-Disciplinary Team Meeting (MDTM) eligible for a treatment with biologics will be included. Half of the patients will immediately receive a biologic. The other half will first undergo the systematic assessment including home monitoring (=EXACT@home) and afterwards a treatment will be chosen based on this evaluation: optimization of treatable traits when present and/or biologics. The chosen treatment of both, the intervention and control group, will be evaluated during 11-12 months.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
138
Start Date
2023-01-31
Completion Date
2026-04-30
Last Updated
2025-03-25
Healthy Volunteers
No
Conditions
Interventions
Budesonide/Formoterol fumarate dihydrate
The Digihaler will measure use of inhalation medication and inhaler technique and will give feedback and reminders. The aim is to improve adherence en inhaler technique. The device/medicinal product will be used for 12 months. It will be used in both groups, but patients in the intervention group are not able to see their own results and will not receive feedback/reminders.
Locations (1)
Franciscus Gasthuis & Vlietland
Rotterdam, South Holland, Netherlands