Tests longer gaps between mepolizumab and dupilumab doses in severe asthma
Tests whether longer dosing gaps for two asthma biologics keep asthma controlled in adults.
Key facts
- Who runs it
- Sint Franciscus Vlietland Groep Stichting
- Where
- Rotterdam, NetherlandsSee the site
- Trial code
- Registry title
- the BIRDIE trial
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 80 people, planned
- Started
- 26 Feb 2024
- Planned end
- 1 Sept 2026
- Type of study
- Interventional
- Record updated
- 3 December 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with severe asthma and stable asthma control who have been treated with mepolizumab or dupilumab for the last 6 months. It tests longer gaps between doses.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Severe asthma, treated with mepolizumab (one dose every 4 weeks) or dupilumab (one dose every 2 weeks) for the last 6 months. Stable asthma for at least 6 months: ACQ below 1.5 and no severe asthma attacks.
- Earlier treatment
- Must have had mepolizumab or dupilumab for the last 6 months. Must not have had other biologics, switched biologics, or immunosuppressants in the last 6 months.
- Biomarker or test result
- The summary describes eosinophil levels (mepolizumab) and FeNO (dupilumab) as the markers used to guide longer dosing gaps. The record does not set a required marker result.
Main reasons for not taking part
- Maintenance oral steroids (14 or more days in a row) in the last 6 months
- Immunosuppressant treatment in the last 6 months
- Other biologic, or a switch between biologics, in the 6 months before joining
- Lung disease other than asthma (including EGPA)
- Pregnancy
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- Severe asthma as primary indication for treatment with mepolizumab (one dose every 4 weeks) or dupilumab (one dose every 2 weeks) for the last 6 months
- Stable asthma (an ACQ <1.5 and no severe asthma exacerbations) for at least 6 months
- Sufficient understanding of the Dutch language
Who cannot take part
- Treatment with maintenance OCS, defined as treatment with OCS during 14 or more subsequent days, in the last 6 months
- Treatment with immunosuppressants (other than mepolizumab, dupilumab or corticosteroids) in the last 6 months
- Treatment with, or switching between, other biologics than the drug of interest in the 6 months before inclusion
- Pulmonary disease(s) other than asthma (including EGPA)
- Pregnancy
Where in Netherlands
- Sint Franciscus Vlietland Groep StichtingRotterdam, NetherlandsTaking people
About the trial
What the trial wants to find out
1. To evaluate if it is possible to extend the dosing interval of mepolizumab, driven by eosinophil levels as biomarker in patients with severe eosinophilic asthma without loss of asthma control 2. To evaluate if it is possible to extend the dosing interval of dupilumab, driven by FeNO as biomarker in patients with severe T2-high asthma without loss of asthma control
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- BIomarker-dRiven Dosing Interval Extension of biologics in asthma (the BIRDIE trial)
- Plain-language title
- Tests longer gaps between mepolizumab and dupilumab doses in severe asthmaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 3 December 2025