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Mepolizumab Effectiveness in Patients With Chronic Rhinosinusitis, Nasal Polyps and Comorbid Severe Eosinophilic Asthma

NCT06069310 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2026-04-17

No results posted yet for this study

Summary

The goal of this observational study is to learn about clinical and functional outcomes in patients with Chronic rhinosinusitis with nasal polyps and comorbid Severe Eosinophilic Asthma and patients with Chronic rhinosinusitis with nasal polyps only treated with mepolizumab compared to healthy controls.

Participants will be asked to give nasal, blood and sputum samples before mepolizumab administration (T0) and at 3 (T3), 6 (T6) and 12 (T12) months after mepolizumab initiation The main aims are to identify airways microbiota modifications and differential gene expression after mepolizumab initiation.

Researchers will compare:

* Patients with Chronic rhinosinusitis with nasal polyps and comorbid Severe Eosinophilic Asthma
* Patients with Chronic rhinosinusitis with nasal polyps only
* Healthy subjects

The research will address the following questions:

1. What are the prospective clinical and functional outcomes of mepolizumab treatment
2. What is the impact of mepolizumab therapy on the airways microbiota and how this may relate to a potentially reduced need for steroids
3. What are the host differential gene expression patterns and the immune/inflammatory (cytokines/chemokines) profile alterations in airways microenvironment and in systemic circulation in response to therapy
4. What are the associations between host and microbiome variables for building up diagnostic and predictive biomarker classifiers of responsive disease endotypes

Conditions

Interventions

DRUG

Mepolizumab 100 MG

Monthly administartion of mepolizumab 100mg

Sponsors & Collaborators

  • National and Kapodistrian University of Athens

    lead OTHER

Principal Investigators

  • Paraskevi Katsaounou, MD, PhD, Msc · National and Kapodistrian University of Athens

  • Eleni Loutrari, PhD · National and Kapodistrian University of Athens

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2026-08-31
Completion
2027-03-30

Countries

  • Greece

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06069310 on ClinicalTrials.gov