Digital health program for managing severe asthma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.