Development of an assay for endotyping nasal polyps via Interleukin-5 signaling and predicting a response to mepolizumab therapy

Recruiting

Conditions: J33
Nasal polyp

Registration Number: DRKS00034017

Lead Sponsor: Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie, St. Josefs-Hospital Hagen der Kath. Krankenhaus Hagen GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

Recurrence of bilateral nasal polyps after one or more sinus surgeries despite current therapy with local and/or systemic cortisone therapy
- Nasal polyp score = 4 out of 8
- SNOT-22 (sino-nasal outcome test-22) = 35 points
- total symptom VAS (visual analog scale) = 5 out of 10 cm or 10 out of 20 cm
- Evidence of type 2 inflammation [13]: Tissue eosinophils = 10/hpf17 or blood eosinophils = 250u/l or total IgE = 100IU/ml

Exclusion Criteria

- Infectious diseases such as HIV, hepatitis B and C
- Tumor diseases
- Autoimmune or non-type 2 inflammatory diseases
- Alcohol consumption in the last 4 weeks and positive rapid test kit result of ethyl glucuronide in urine
- Cigarette consumption in the last 4 weeks and positive rapid test kit result of cotinine in urine
- Use of illegal drugs in the last 12 weeks and positive rapid test kit result
- Therapy with other biologics in the last 12 weeks
- Acute infection or elevation of both leukocytes and C-reactive protein in the blood
- Use of systemic steroids in the last 4 weeks18
- pregnancy and breast-feeding

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Characterization and differentiation of chronic rhinosinusitis with nasal polyps (CRSwNP) through the interleukin-5 signaling pathway and prediction of response to therapy with mepolizumab (from nasal tissue, nasal secretions, whole blood, serum).

Secondary Outcome Measures