Digital health program for managing severe asthma
Expertise Asthma COPD Program with Digital Support
This study is testing a digital health program to help people with severe asthma manage their condition better by using tools like a digital inhaler and activity tracker.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 138 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Franciscus Gasthuis Academic / other |
| Drugs / interventions | omalizumab, mepolizumab, benralizumab, reslizumab, dupilumab |
| Locations | 1 site (Rotterdam, South Holland) |
| Trial ID | NCT05831566 on ClinicalTrials.gov |
What this trial studies
The EXACT@Home program aims to enhance the management of patients with severe asthma through a digital health platform that utilizes questionnaires and various digital devices. This program focuses on identifying and addressing treatable traits such as poor medication adherence and dysfunctional breathing to optimize the use of biologics. Patients will use a digital inhaler, activity tracker, hand-held spirometer, and FeNO measuring device, with data collected in a Personal Digital Healthcare Environment (PDHE) to improve treatment outcomes. The study is conducted by a Multi-Disciplinary Team Meeting (MDTM) that evaluates patients for biologic therapy eligibility.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with severe, refractory asthma who are eligible for biologic treatments.
Not a fit: Patients with primary COPD or those with a history of certain cancers may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve asthma control and quality of life for patients with severe asthma.
How similar studies have performed: Other studies have shown promise in using digital health interventions for asthma management, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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 (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).
Where this trial is running
Rotterdam, South Holland
- Franciscus Gasthuis & Vlietland — Rotterdam, South Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: J.C.C.M. In 't Veen, dr. — Franciscus Gasthuis & Vlietland
- Study coordinator: L. Bult, drs.
- Email: l.bult@franciscus.nl
- Phone: +31104616149
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.