Expertise Asthma COPD Program with Digital Support

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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) as determined at the regional asthma MDTM according to the asthma guidelines

• Age ≥ 18 years.

• Previous prescribed asthma biologics have to be ceased ≥ 4 times the half-life of that specific biologic.

• The patient has be relatively stable. The onset of an asthma exacerbation and/or a respiratory infection has to be ≥ 4 weeks ago.

Locations
Other Locations
Netherlands
Franciscus Gasthuis & Vlietland
RECRUITING
Rotterdam
Contact Information
Primary
L. Bult, drs.
l.bult@franciscus.nl
+31104616149
Backup
J.C.C.M. In 't Veen, dr.
h.intveen@franciscus.nl
Time Frame
Start Date: 2023-01-31
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 138
Treatments
Experimental: Intervention arm (EXACT@home)
These patients will first undergo the systematic assessment (=EXACT@home) of +/- 6 weeks including a systematic anamnesis, questionnaires and home monitoring with multiple digital devices (digital inhaler, activity tracker, hand-held spirometer and FeNO measuring device) and a Personal Digital Health Environment (PDHE). Based on this evaluation and the degree of asthma control a treatment will be chosen: optimization of treatable traits if present and/or biologics.~The personal digital healthcare environment and digital inhaler will be used for 12 months and the activity tracker, hand-held spirometer and FeNO measuring device will be used for 12 weeks.
Active_comparator: Control arm (biologics)
These patients will immediately receive a biologic after the indication is determined at the regional asthma Multi-Disciplinary Team Meeting (MDTM). These patients also have access to the Personal Digital Health Environment (PDHE) and they will also use the digital inhaler but without being able to see their own results or receiving feedback/reminders (silent).~The personal digital healthcare environment and digital inhaler will be used for 12 months.
Sponsors
Collaborators: Teva Pharmaceuticals USA
Leads: Franciscus Gasthuis

This content was sourced from clinicaltrials.gov