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Real life observational study of treatment success of monoclonal antibody treatment for refractory chronic rhinosinusitis with nasal polyps.

Real life observational study of treatment success of monoclonal antibody treatment for refractory chronic rhinosinusitis with nasal polyps.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00031311
Enrollment
30
Registered
2023-03-07
Start date
2023-01-31
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

J30

Interventions

Group 1: Patients of the ENT University Clinic Freiburg for whom biologic therapy was started by 31.10.2022 due to CRSwNP according to the existing indication criteria. -the patient undergo endonasal

Sponsors

HNO Uniklinik
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Age = 18 years at therapy initiation - Diagnosis of severe therapy-resistant chronic rhinosinusitis with nasal polyposis and indication for therapy with one of the approved biologics at the ENT University Hospital Freiburg in the analysis period 2019 to 2022. - Consent to data collection

Exclusion criteria

Exclusion criteria: Age < 18 years at initiation of therapy - Lack of indication for biologic therapy - Lack of consent to data collection

Design outcomes

Primary

MeasureTime frame
- Change in SNOT-22 quality of life as difference from baseline before biologic therapy 1 year after therapy initiation. - Change in nasal polyp score as difference from baseline before biologic therapy 1 year after initiation of therapy

Secondary

MeasureTime frame
Change in SNOT-22 quality of life as difference from baseline before biologic therapy 4 weeks, 3 months and 6 months after therapy initiation. - Change in nasal polyp score as a difference from baseline before biologic therapy 4 weeks, 3 months and 6 months after initiation of therapy - Change in ability to smell - Adverse events during therapy - Number of sinus surgeries during ongoing biologic therapy - Change of biologic due to non-response or complications - Number of previous surgeries - Demographic data (age, gender) - Comorbidities (bronchial asthma, ASA intolerance)

Countries

Germany

Contacts

Public ContactTanja Hildenbrand

Uniklinik Freiburg

kathrin.gerstacker@uniklinik-freiburg.de+4927041010

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026