RecruitingPhase 3NCT05831566

Expertise Asthma COPD Program with Digital Support

Sponsor

Franciscus Gasthuis

Enrollment

138 participants

Start Date

Jan 31, 2023

Study Type

INTERVENTIONAL

Conditions

Asthma

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

Min Age: 18 Years

Inclusion Criteria5

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.

Exclusion Criteria10

Primary COPD diagnosis.
History of cancer:
Current basal cell carcinoma, localized squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients are eligible to participate in the study provided that curative therapy was completed at least 12 months prior to the start of the study.
Current other malignancies. Patients are eligible to participate in the study provided that curative therapy was completed at least 5 years prior to the start of the study.
Inability to sufficiently understand and read the Dutch language.
Being unable to engage in a remote monitoring and coaching program through the use of a smartphone.
Being unable to engage in physical activity (e.g. physical disability).
Current pregnancy.
Current breastfeeding.
A liaison with the coordinating or (principal) investigator, which could likely influence the decision to participate in this study voluntarily (in concordance with the WMO - article 5).

Interventions

DRUGBudesonide/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.