Expertise Asthma COPD Program with Digital Support

ConditionAsthma

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorFranciscus Gasthuis

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Primary COPD diagnosis.

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Budesonide/Formoterol fumarate dihydrate
Drug
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.

Treatment groups

138 Participants

are divided into 2 treatment groups

Group A: Intervention arm (EXACT@home)Experimental treatment 1 intervention

Group B: Control arm (biologics)Active comparator 1 intervention

Trial outcomes

Primary outcomes

Difference in percentage of patients treated with biologicals after 6 months of follow up

Difference in number of patients who receive treatment with biologics in the intervention arm compared with the control arm

Time frame

6 months

Secondary outcomes

Difference in percentage of patients treated with biologicals after 12 months of follow up

Difference in number of patients who receive treatment with biologics in the intervention arm compared with the control arm

Time frame

12 months

Difference in change in asthma control over time between the intervention- and control group

Asthma Controle assessed with the Asthma Control Questionnaire (ACQ-5). This questionnaire consists of five questions about the severity of symptoms which a patient experieces. The score range per question is 0-7 (0 = never and 7 = always). The total score will be calculated by dividing the sum of all scores by the amount of questions. A higher score is associated with worse asthma control.

Time frame

6-12 months

Difference in change in quality of life over time between the intervention- and control group

Disease specific quality of life is measured with the Asthma Quality of Life Questionnaire (mini AQLQ). The mini AQLQ consists of 15 questions, which are subdivided into 4 domains (symptoms, activity limitation, emotional function and environmental stimuli). Each question has a 7-point scale (7 = not impaired at all - 1 = severely impaired). The overall score is the mean of all 15 responses. A lower score corresponds to a better quality of life.

Time frame

6-12 months

Difference in asthma exacerbation frequency

Asthma exacerbation frequency

Time frame

6-12 months

Other outcomes

Difference in change in spirometry and FeNO over time between the intervention - and control group.

Spirometry (e.g. FEV1, FVC) and FeNO measurements

Time frame

6-12 months

Difference in direct healthcare consumption between the intervention- and control group

A Health Care Resource Utilization analysis will be performed by measuring the number of hospitalizations, the duration of hospitalization, the number of unscheduled visits to a health care provider (such as visits to the emergency department, general practitioner and outpatient clinic) all related to asthma and asthma exacerbations for which prednisolone with or without antibiotics was needed. This together with the cost of asthma biologics and equipment, staff and logistics for implementation and evaluation of EXACT@home.

Time frame

6-12 months

Difference in prednisolone courses between the intervention- and control group.

Number of prednisolon courses

Time frame

6-12 months

Difference in reduction in prednisolone maintenance therapy (if applicable) between the intervention and control group

Reduction in prednisolon maintenace therapy between the intervention- and control group. Reduction is defined as a decrease in prednisolon maintance therapy of ≥ 5 mg.

Time frame

6-12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Franciscus Gasthuis

Lead sponsor

Teva Pharmaceuticals USA

Collaborator

Source ClinicalTrials.gov

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