Efficacy, Safety, and Biomarker Exploration of Mepolizumab Therapy for Postoperative Recurrent Eosinophilic Chronic Rhinosinusitis: A Prospective Multicenter Cohort Study

Efficacy, Safety, and Biomarker Exploration of Mepolizumab Therapy for Postoperative Recurrent Eosinophilic Chronic Rhinosinusitis: A Prospective Multicenter Cohort Study - Exploration of Clinical Biomarkers for Mepolizumab Therapy in Postoperative Recurrent Eosinophilic Chronic Rhinosinusitis

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000059706

Enrollment

Registered

2026-01-05

Start date

2026-01-05

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Postoperative Recurrent Eosinophilic Chronic Rhinosinusitis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with postoperative recurrent eosinophilic chronic rhinosinusitis who are currently receiving or scheduled to receive treatment with mepolizumab. Among those, patients who have received a full explanation of the study and have provided written informed consent will be included.

Exclusion criteria

Exclusion criteria: Patients who are already receiving mepolizumab treatment for bronchial asthma or eosinophilic granulomatosis with polyangiitis. Patients who decline to participate in this study.

Design outcomes

Primary

Measure	Time frame
A The following scores and subjective symptoms will be evaluated over time Nasal obstruction visual analogue scale VAS score 0 10 Nasal polyp score Each nasal cavity will be scored from 0 to 4 total score 0 8 Overall nasal symptom self assessment based on the baseline Patients will subjectively evaluate their overall nasal symptoms including nasal obstruction nasal discharge and olfactory disturbance as worsened no change slightly improved or significantly improved B At week 24 of treatment patients who rate their overall nasal symptoms as slightly improved or significantly improved in the self assessment will be classified as responders while the remaining patients will be classified as non responders Factors associated with treatment responsiveness will be analyzed as follows Clinical factors Age Sex Presence or absence of other immunoallergic diseases eg bronchial asthma NSAID exacerbated respiratory disease NSAID hypersensitivity atopic dermatitis allergic rhinitis etc History of dupilumab treatment Tissue eosinophil count evaluated using biopsy or surgical specimens obtained prior to mepolizumab administration Peripheral blood eosinophil count percent cells uL assessment time points specified Serum total IgE IU mL assessment time points specified Location of recurrent nasal polyps middle meatus olfactory cleft or sphenoethmoidal recess	—

Measure

Time frame

A The following scores and subjective symptoms will be evaluated over time Nasal obstruction visual analogue scale VAS score 0 10 Nasal polyp score Each nasal cavity will be scored from 0 to 4 total score 0 8 Overall nasal symptom self assessment based on the baseline Patients will subjectively evaluate their overall nasal symptoms including nasal obstruction nasal discharge and olfactory disturbance as worsened no change slightly improved or significantly improved B At week 24 of treatment patients who rate their overall nasal symptoms as slightly improved or significantly improved in the self assessment will be classified as responders while the remaining patients will be classified as non responders Factors associated with treatment responsiveness will be analyzed as follows Clinical factors Age Sex Presence or absence of other immunoallergic diseases eg bronchial asthma NSAID exacerbated respiratory disease NSAID hypersensitivity atopic dermatitis allergic rhinitis etc History of dupilumab treatment Tissue eosinophil count evaluated using biopsy or surgical specimens obtained prior to mepolizumab administration Peripheral blood eosinophil count percent cells uL assessment time points specified Serum total IgE IU mL assessment time points specified Location of recurrent nasal polyps middle meatus olfactory cleft or sphenoethmoidal recess

—

Countries

Japan

Contacts

Public ContactMami Matsunaga

Department of Otolaryngology, Head and Neck Surgery Graduate School of Medicine, Kyoto University

m_matsunaga@ent.kuhp.kyoto-u.ac.jp0757513346

Outcome results