AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

Tapering of Biologics in Chronic Rhinosinusitis With Nasal Polyps

RecruitingPhase 4Ages 18 Years - anyAllCopenhagen University Hospital, Rigshospitalet
💬

In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
💊

What it tests

  • increased dosing interval of biological therapy
📍

Where

9 sites
Dept of otorhinolaryngology, Aalborg University Hospital
Aalborg, Denmark
Dept of otorhinolaryngology, head and neck surgery, Aarhus University Hospital
Aarhus, Denmark
Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Copenhagen University, Rigshospitalet
Copenhagen, Denmark
Esbjerg Og Grindsted Sygehus
Esbjerg, Denmark
Dept of otorhinolaryngology, Gødstrup Regional Hospital
Herning, Denmark
Dept of otorhinolaryngology, Nordsjaellands Hospital
Hillerød, Denmark
Dept of otorhinolaryngology, Sjællands Universitetshospital
Køge, Denmark
Dept of otorhinolaryngology, Odense University Hospital
Odense, Denmark

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy