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
This trial does not accept healthy volunteersQualifiers
≥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
Design model
Parallel
Treatments tested in this trial
increased dosing interval of biological therapy
DrugIncreasing 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.
Treatment groups
135 Participants
are divided into 2 treatment groupsGroup A: Standard dosing of biological therapyNo intervention 0 interventions
Group B: Increased dosing interval of biological therapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The percentage of patients achieving sustained partly controlled disease after tapering of biologics for CRSwNP
"partly controlled" as defined by presence of 1-2 of the following 7 items: 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
Time frame
from enrollment (week 0) to week 52.Sponsors and contacts
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Source ClinicalTrials.gov