NCT07187583 Tapering of Biologics in Chronic Rhinosinusitis With Nasal Polyps
| NCT ID | NCT07187583 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Rigshospitalet, Denmark |
| Condition | Chronic Rhinosinusitis With Nasal Polyps |
| Study Type | INTERVENTIONAL |
| Enrollment | 135 participants |
| Start Date | 2025-06-05 |
| Primary Completion | 2028-03-01 |
Trial Parameters
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Brief 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 Criteria
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