Recruiting

Testing digital monitoring to improve difficult asthma treatment

Plain-English translation of NCT05831566 on ClinicalTrials.gov ↗ · Source last updated March 2025 · Translation generated June 2026 · How we translate trials

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Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.

What is this trial?

This trial is testing a new approach called the EXACT@Home program for people with severe asthma that hasn't been controlled by standard medications. Instead of immediately starting biologic medications (like omalizumab, mepolizumab, benralizumab, reslizumab, or dupilumab), the program uses digital devices and questionnaires over 6 weeks to get a complete picture of what's really going wrong with your asthma. This detailed assessment helps doctors decide whether you need the medication, lifestyle changes, or both.

About 1 in 5 people with asthma have "difficult-to-treat" asthma, but it's not always because they need expensive biologic medications—sometimes it's due to things like poor inhaler technique, breathing habits, or not taking medications as prescribed. This trial exists to see if using home-based digital monitoring can help doctors spot these overlooked problems before deciding whether to start the medication, saving time and ensuring you get the right treatment.

Do you qualify?

You likely qualify if…

you have been diagnosed with severe asthma that has not responded to standard medications
you are at least 18 years old
you have confirmed asthma based on specific lung function tests or airway sensitivity tests
you have been stable for at least 4 weeks since your last asthma attack or respiratory infection
you are able to use a smartphone and engage with a remote monitoring program
you can read and understand Dutch

You likely don't qualify if…

you have a primary diagnosis of COPD instead of asthma
you are currently pregnant or breastfeeding
you have a history of cancer (unless treated successfully at least 5 years ago, or certain skin cancers treated at least 12 months ago)
you are unable to engage in physical activity due to a disability
you recently stopped a biologic asthma medication (you must wait at least 4 times the medication's half-life)

What participation looks like

If you join the digital monitoring group, you'll use several devices at home for 6–12 weeks: a special digital inhaler, an activity tracker, a handheld device to measure lung function, and a device to measure airway inflammation. You'll also answer questionnaires and use a personal digital health app. After this assessment period, your doctors will decide on the best treatment for you—whether that's fixing medication technique, making lifestyle changes, or starting a biologic medication. You'll continue using some devices for up to 12 months. The control group will start biologic medication right away and use fewer monitoring devices.

Testing digital monitoring to improve difficult asthma treatment

What is this trial?

Do you qualify?

What participation looks like

Trial locations(1 site)