Status:
RECRUITING
Tapering of Biologics in Chronic Rhinosinusitis With Nasal Polyps
Lead Sponsor:
Rigshospitalet, Denmark
Conditions:
Chronic Rhinosinusitis With Nasal Polyps
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to investigate the feasibility of extending the dosing intervals of biological therapies while maintaining optimal treatment effects in chronic rhinosinusitis with nasal p...
Detailed Description
This is an investigator-initiated, independent, national multicenter study with a real-world design and Good Clinical Practice (GCP) monitoring. The study is a randomized controlled drug trial investi...
Eligibility Criteria
Inclusion
- ≥18 years of age.
- Currently receiving treatment with either dupilumab (300 mg) or mepolizumab (100 mg) every four weeks.
- Having received the biologic at unchanged dosing interval for at least three months.
- For at least one year during treatment with biologics, the patients' CRSwNP must be categorized as "partly controlled" as defined by presence of 1-2 of the following seven items (also available in EPOS 2020 table in protocol):
- Nasal blockage: present on most days of the week
- Rhinorrhoea/postnasal drip: mucopurulent on most days of the week
- Facial pain/pressure: present on most days of the week
- Sense of smell: impaired
- Sleep disturbance or fatigue: present
- Nasal endoscopy: diseased mucosa
- Rescue treatment (systemic corticosteroids, ESS, antibiotics): need of 1 course of rescue treatment
- of which 1-5 will be scored by the patient using VAS (0-10) and noted above 5.
Exclusion
- Patients with excellent response to biologics (0 of the above-mentioned 7 items for partly controlled disease)
- Patients with no or limited response to biologics (\>2 of the above-mentioned 7 items for partly controlled disease)
- Patients with a cancer diagnosis deemed by the investigator to preclude participation in the trial
- Patients who, because of language barriers, are not able to understand Danish written information and, thus, are not able to answer questionnaires
- Patients who currently receive biologics for any other disease (asthma not included)
- Patients who are not able to give informed consent (i.e., patients who are permanently incapable)
- Patients who are not eligible because of the investigator's judgement
- Patients who experience pregnancy during the study will be excluded after an unscheduled visit - active IVF treatment (please see below)
- Unwillingness to follow the study procedure
Key Trial Info
Start Date :
June 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT07187583
Start Date
June 5 2025
End Date
March 1 2028
Last Update
September 23 2025
Active Locations (9)
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1
Dept of otorhinolaryngology, Aalborg University Hospital
Aalborg, Denmark, 9000
2
Dept of otorhinolaryngology, head and neck surgery, Aarhus University Hospital
Aarhus, Denmark, 8200
3
Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Copenhagen University, Rigshospitalet
Copenhagen, Denmark, 2100
4
Esbjerg Og Grindsted Sygehus
Esbjerg, Denmark, 6700