Tapering of Biologics in Chronic Rhinosinusitis With Nasal Polyps
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorRigshospitalet, Denmark
About this trial
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 criteria
Qualifiers
≥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.
Nasal blockage: present on most days of the week
Disqualifiers
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
Trial design
Treatments tested in this trial
- increased dosing interval of biological therapy
Treatment groups
135 Participants
are divided into 2 treatment groupsLocations
9Dept of otorhinolaryngology, Aalborg University Hospital9000, Aalborg Denmark
Dept of otorhinolaryngology, head and neck surgery, Aarhus University Hospital8200, Aarhus Denmark
Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Copenhagen University, Rigshospitalet2100, Copenhagen Denmark
Esbjerg Og Grindsted Sygehus6700, Esbjerg Denmark
Sponsors and collaborators
Rigshospitalet, Denmark
Lead sponsor
Source ClinicalTrials.gov