Actively Recruiting
Expertise Asthma COPD Program with Digital Support
Led by Franciscus Gasthuis · Updated on 2025-03-25
138
Participants Needed
1
Research Sites
169 weeks
Total Duration
On this page
Sponsors
F
Franciscus Gasthuis
Lead Sponsor
T
Teva Pharmaceuticals USA
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Expertise Asthma COPD Program with Digital Support
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed asthma diagnosis with at least 12% and >200 ml reversibility in FEV1 or positive histamine/methacholine provocation test or FeNO ≥50 according to asthma guidelines
- Diagnosed with severe, refractory asthma eligible for specific asthma biologics as determined by the regional asthma Multi-Disciplinary Team Meeting
- Age 18 years or older
- Previous asthma biologic treatments stopped for at least four times their half-life
- Stable condition with no asthma exacerbation or respiratory infection in the last 4 weeks
You will not qualify if you...
- Primary diagnosis of COPD
- Current basal cell carcinoma, localized squamous cell carcinoma of the skin, or in situ carcinoma of the cervix unless curative therapy was completed at least 12 months prior
- Current other malignancies unless curative therapy was completed at least 5 years prior
- Inability to understand and read Dutch sufficiently
- Unable to participate in remote monitoring and coaching using a smartphone
- Unable to engage in physical activity due to disability
- Current pregnancy
- Current breastfeeding
- Relationship with the study investigator that could affect voluntary participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Franciscus Gasthuis & Vlietland
Rotterdam, South Holland, Netherlands, 3045PM
Actively Recruiting
Research Team
L
L. Bult, drs.
CONTACT
J
J.C.C.M. In 't Veen, dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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