Expertise Asthma COPD Program with Digital Support
Recruiting
Phase 3Interventional Study
Asthma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
138 (estimated)
Sponsor
Franciscus Gasthuis · Other
Who this trial is looking for
This trial is looking for adults with severe asthma to participate in a health program that uses digital tools to improve treatment. Participants will either start treatment with a specific asthma medication right away or go through an assessment before starting treatment.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with asthma
I am at least 18 years old
I have severe asthma that is hard to control
I have been deemed eligible for specific asthma medications
I can understand and read Dutch
I am relatively stable and have not had an asthma attack in the last 4 weeks
I have stopped taking previous asthma biologics for an adequate period
You may not be able to join if
I have a primary diagnosis of COPD
I currently have cancer or have had a recent history of cancer
I cannot use a smartphone for remote monitoring
I am currently pregnant
I am currently breastfeeding
I cannot engage in physical activity
I have a relationship that might influence my decision to participate
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 de…
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.
Trial Locations
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Eligibility Criteria
Inclusion criteria:
* 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 (oma…
Inclusion criteria:
* 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 criteria:
* 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).
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