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 groupsSponsors and collaborators
Source ClinicalTrials.gov