Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT07187583

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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