Expertise Asthma COPD Program with Digital Support

NCT05831566 | Recruiting Phase 3

• 1 other identifier: NL79996.100.22
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma

Keywords

severe asthma; ehealth; digital home monitoring; difficult to treat asthma; treatable traits; assessment; biologics

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Secondary Outcomes (4)

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

  12 months

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

  6-12 months

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

  6-12 months

• Difference in asthma exacerbation frequency

  6-12 months

Other Outcomes (16)

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

  6-12 months

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

  6-12 months

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

  6-12 months

Study Arms (2)

Intervention arm (EXACT@home)

EXPERIMENTAL

These patients will first undergo the systematic assessment (=EXACT@home) of +/- 6 weeks including a systematic anamnesis, questionnaires and home monitoring with multiple digital devices (digital inhaler, activity tracker, hand-held spirometer and FeNO measuring device) and a Personal Digital Health Environment (PDHE). Based on this evaluation and the degree of asthma control a treatment will be chosen: optimization of treatable traits if present and/or biologics. The personal digital healthcare environment and digital inhaler will be used for 12 months and the activity tracker, hand-held spirometer and FeNO measuring device will be used for 12 weeks.

Drug: Budesonide/Formoterol fumarate dihydrate

Control arm (biologics)

ACTIVE COMPARATOR

These patients will immediately receive a biologic after the indication is determined at the regional asthma Multi-Disciplinary Team Meeting (MDTM). These patients also have access to the Personal Digital Health Environment (PDHE) and they will also use the digital inhaler but without being able to see their own results or receiving feedback/reminders (silent). The personal digital healthcare environment and digital inhaler will be used for 12 months.

Drug: Budesonide/Formoterol fumarate dihydrate

Interventions

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.

Also known as: Budesonide Formoterol (BF) Digihaler Digital System (DS)

Control arm (biologics); Intervention arm (EXACT@home)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Franciscus Gasthuis: lead
• Teva Pharmaceuticals USA: collaborator

Study Sites (1)

Franciscus Gasthuis & Vlietland

Rotterdam, South Holland, 3045PM, Netherlands

RECRUITING

Related Publications (1)

• Bult L, Braunstahl GJ, Aerts JGJV, Banffer D, van Campen JSJA, van Daalen MS, van Dooren Y, Flanders U, Geurts ES, Hekking PP, Heller-Baan R, Jans MJA, Kappen JH, Mies RCA, Oppedijk B, de la Roij-Hartmans M, Van der Sar-Van der Brugge S, Turk Y, Vis E, Wolters R, Vasbinder EC, Veen JCCMI'. The effect of a systematic multi-dimensional assessment in severe uncontrolled asthma: a literature review and protocol for an investigator-initiated, open-label, randomized-controlled trial (EXACT@home study). BMC Pulm Med. 2025 May 17;25(1):240. doi: 10.1186/s12890-025-03646-5.

  PMID: 40382637 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Budesonide; Budesonide, Formoterol Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Formoterol Fumarate; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Drug Combinations; Pharmaceutical Preparations

Study Officials

• J.C.C.M. In 't Veen, dr.

  Franciscus Gasthuis & Vlietland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

L. Bult, drs.

CONTACT

+31104616149; l.bult@franciscus.nl

J.C.C.M. In 't Veen, dr.

CONTACT

h.intveen@franciscus.nl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Open-label, randomized controlled trial with a superiority design. Patients will be randomly assigned to one of two groups in parallel for the duration of the study. They will either recieve biologics directly or they will undergo an in-dept assessment to map the asthma diagnosis in more detail.

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: April 26, 2023
• Study Start: January 31, 2023
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2026
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)