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Clinical Trials in Denmark / NCT07187583
Recruiting Phase 4

Tapering of Biologics in Chronic Rhinosinusitis With Nasal Polyps

NCT07187583 · tracked via the Priya Life Science Denmark tracker
Phase
Phase 4
Started
2025-06-05
Last updated
2025-09-23

Condition(s) studied

Chronic Rhinosinusitis With Nasal Polyps

Investigational drug(s) / intervention(s)

increased dosing interval of biological therapy

increased dosing interval of biological therapy: Increasing dosing interval of biological therapy for CRSwNP from every 4 weeks to every 6 weeks and if continued satisfactory response then to every 8 weeks.

Study 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 polyps (CRSwNP).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * ≥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): 1. Nasal blockage: present on most days of the week 2. Rhinorrhoea/postnasal drip: mucopurulent on most days of the week 3. Facial pain/pressure: present on most days of the week 4. Sense of smell: impaired 5. Sleep disturbance or fatigue: present 6. Nasal endoscopy: diseased mucosa 7. 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 Criteria: * 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

Primary outcome measure(s)

Trial sites (9)

FacilityCityRegionStatus
Dept of otorhinolaryngology, Aalborg University Hospital Aalborg Denmark Not Yet Recruiting
Dept of otorhinolaryngology, head and neck surgery, Aarhus University Hospital Aarhus Denmark Not Yet Recruiting
Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Copenhagen University, Rigshospitalet Copenhagen Denmark Recruiting
Esbjerg Og Grindsted Sygehus Esbjerg Denmark Not Yet Recruiting
Dept of otorhinolaryngology, Gødstrup Regional Hospital Herning Denmark Not Yet Recruiting
Dept of otorhinolaryngology, Nordsjaellands Hospital Hillerød Denmark Recruiting
Dept of otorhinolaryngology, Sjællands Universitetshospital Køge Denmark Recruiting
Dept of otorhinolaryngology, Odense University Hospital Odense Denmark Not Yet Recruiting
Dept of otorhinolaryngology, Lillebaelt Hospital Vejle Denmark Not Yet Recruiting

More Rigshospitalet, Denmark trials in Denmark

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07187583 on ClinicalTrials.gov ↗ ← All trials in Denmark