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RECRUITING
NCT05831566
PHASE3

Expertise Asthma COPD Program with Digital Support

Sponsor: Franciscus Gasthuis

View on ClinicalTrials.gov

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

DRUG

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