Actively Recruiting
Complete Remission After Treatment With Biologics for Nasal Polyps
Led by Rigshospitalet, Denmark · Updated on 2025-12-05
66
Participants Needed
6
Research Sites
112 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In this RCT the investigators randomize patients who are treated with biologic treatment (Nucala or Dupixent) due to nasal polyps and have controlled disease within the last year to either stop treatment og continue as a control group.
CONDITIONS
Official Title
Complete Remission After Treatment With Biologics for Nasal Polyps
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must meet EPOS criteria for starting biologic treatment for chronic rhinosinusitis with nasal polyps
- Presence of bilateral nasal polyps
- Have had sinus surgery (ESS), except in exceptional cases
- Meet at least three of the following: evidence of type 2 inflammation, need for systemic corticosteroids or contraindications to them, SNOT-22 score of 40 or above, significant loss of smell, asthma requiring regular inhaled corticosteroids
- At least 18 years old
- Currently on stable treatment with Dupilumab 300 mg or Mepolizumab 100 mg every four weeks for at least three months
- Disease controlled for at least one year with symptom scores of five or below on a VAS scale for nasal blockage, rhinorrhea/postnasal drip, facial pain/pressure, smell, sleep disturbance, or fatigue
- Nasal endoscopy within the past year showing polyp scores no higher than 1+1 out of 4+4, without thick secretions or general edema
- No sinus surgery or rescue treatment for nasal polyps in the past year
- Able to understand Danish and provide informed consent
You will not qualify if you...
- Acute exacerbation of chronic rhinosinusitis during the last 12 months (common cold allowed)
- Polyp removal in outpatient clinic within the last 3 months
- Uncontrolled asthma with ACQ score higher than 1.2 within the last year
- Inability to understand written information or answer questionnaires due to language barriers
- Receiving biologic treatment for diseases other than asthma
- Unable to provide informed consent
- Considered ineligible by the investigator
- Pregnancy during the study or undergoing active IVF treatment
- Recent or current illnesses like cancer expected to affect health or quality of life significantly in the next two years
- Unwillingness to follow study procedures
- Known hypersensitivity to Dupilumab or Mepolizumab
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Rigshospitalet
Copenhagen, Region H, Denmark, 2100
Actively Recruiting
2
Nordsjællands hospital
Hillerød, Region H, Denmark, 3400
Actively Recruiting
3
Køge øre næse hals afd
Køge, Region Sj, Denmark, 4600
Actively Recruiting
4
Dept. of otorhinolaryngology, Odense
Odense, Region Syd, Denmark, 5000
Actively Recruiting
5
Vejle sygehus
Vejle, Region S, Denmark, 7100
Actively Recruiting
6
Gødstrup Hospital
Gødstrup, Denmark
Actively Recruiting
Research Team
K
Kasper Aanæs, md, phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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