Actively Recruiting
Tapering of Biologics in Chronic Rhinosinusitis With Nasal Polyps
Led by Rigshospitalet, Denmark · Updated on 2025-09-23
135
Participants Needed
9
Research Sites
142 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 polyps (CRSwNP).
CONDITIONS
Official Title
Tapering of Biologics in Chronic Rhinosinusitis With Nasal Polyps
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Currently treated with dupilumab (300 mg) or mepolizumab (100 mg) every 4 weeks
- Receiving the biologic at an unchanged dosing interval for at least 3 months
- Have had partly controlled chronic rhinosinusitis with nasal polyps for at least 1 year, defined by presence of 1-2 specific symptoms such as nasal blockage, rhinorrhoea, facial pain, impaired smell, sleep disturbance, diseased mucosa, or need for rescue treatment
You will not qualify if you...
- Excellent response to biologics with none of the 7 defined symptoms for partly controlled disease
- No or limited response to biologics with more than 2 of the 7 defined symptoms for partly controlled disease
- Cancer diagnosis that prevents participation
- Unable to understand Danish written information due to language barriers
- Receiving biologics for diseases other than asthma
- Unable to give informed consent (permanently incapable)
- Deemed ineligible by the investigator
- Pregnancy during the study after an unscheduled visit
- Active IVF treatment
- Unwillingness to follow the study procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Dept of otorhinolaryngology, Aalborg University Hospital
Aalborg, Denmark, 9000
Not Yet Recruiting
2
Dept of otorhinolaryngology, head and neck surgery, Aarhus University Hospital
Aarhus, Denmark, 8200
Not Yet Recruiting
3
Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Copenhagen University, Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
4
Esbjerg Og Grindsted Sygehus
Esbjerg, Denmark, 6700
Not Yet Recruiting
5
Dept of otorhinolaryngology, Gødstrup Regional Hospital
Herning, Denmark, 7400
Not Yet Recruiting
6
Dept of otorhinolaryngology, Nordsjaellands Hospital
Hillerød, Denmark, 3400
Actively Recruiting
7
Dept of otorhinolaryngology, Sjællands Universitetshospital
Køge, Denmark, 4600
Actively Recruiting
8
Dept of otorhinolaryngology, Odense University Hospital
Odense, Denmark, 5000
Not Yet Recruiting
9
Dept of otorhinolaryngology, Lillebaelt Hospital
Vejle, Denmark, 7100
Not Yet Recruiting
Research Team
E
Elizabeth M. Stevens Saporito, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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