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

NCT06069310 | Active Not Recruiting

• 1 other identifier: 14919
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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:
• What are the prospective clinical and functional outcomes of mepolizumab treatment
• What is the impact of mepolizumab therapy on the airways microbiota and how this may relate to a potentially reduced need for steroids
• 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
• What are the associations between host and microbiome variables for building up diagnostic and predictive biomarker classifiers of responsive disease endotypes

Conditions

Chronic Rhinosinusitis With Nasal Polyps; Severe Eosinophilic Asthma; Chronic Rhinosinusitis Without Nasal Polyps

Keywords

Chronic Rhinosinusitis; Severe Eosinophilic Asthma; Microbiome; Nasal Polyps; Mepolizumab

Outcome Measures

Primary Outcomes (2)

• Mean change from baseline in Sino-nasal outcome test-22 (SNOT-22) score

  SNOT-22 score will be considered as a measure of post-treatment alterations in CRSwNP clinical symptoms

  at baseline and in 3, 6 and 12 months

• Asthma control test (ACT)

  ACT will assess potential treatment-induced alterations in asthma symptoms

  at baseline and in 3, 6 and 12 months

Secondary Outcomes (15)

• Mean change of nasal endoscopic polyps score

  at baseline and in 3, 6 and 12 months

• Mean change of the polyposis severity visual analog scale (VAS) score

  at baseline and in 3, 6 and 12 months

• Forced Expiratory Volume at 1 s % (%FEV1: FEV1/FEV1 predicted) and Morning Peak Expiratory Flow measurements

  at baseline and in 3, 6 and 12 months

• Fractional Exhaled Nitric Oxide Testing (FENO)

  at baseline and in 3, 6 and 12 months

• Forced oscillation technique (FOT) measurements at baseline and after 3, 6 and 12 months of mepolizumab treatment

  at baseline and in 3, 6 and 12 months

Study Arms (3)

Healthy control subjects

Healthy control subjects withouth asthma nor chronic rhinosinusitis or other chronic respiratory diseases

Chronic rhinosinusitis with nasal polyps (CRSwNP) patients with comorbid severe asthma

Patients that have chronic rhinosinusitis with nasal polyps (CRSwNP) and comorbid severe asthma will be enrolled

Drug: Mepolizumab 100 MG

Chronic rhinosinusitis with nasal polyps (CRSwNP) patients without asthma

Patients that have chronic rhinosinusitis with nasal polyps (CRSwNP) without asthma will be enrolled

Drug: Mepolizumab 100 MG

Interventions

Mepolizumab 100 MG DRUG

Monthly administartion of mepolizumab 100mg

Also known as: nucala

Chronic rhinosinusitis with nasal polyps (CRSwNP) patients with comorbid severe asthma; Chronic rhinosinusitis with nasal polyps (CRSwNP) patients without asthma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We estimate to recruit 40 CRSwNP patients (20 with and 20 without severe asthma) and 20 healthy control subjects. All participants will be adults (18 years and older) of both sexes. Clinical evaluation of CRSwNP and asthma will be made according to the European Position Paper on Rhinosinusitis and Nasal Polyps. Patients with significant sino-nasal disease and/or those who fail medical management will be evaluated for functional endoscopic sinus surgery.

You may qualify if:

• Eligible to treatment women in childbearing potential will be informed before consent that they must take care of contraception and potential pregnancy during therapy as there is not enough data regarding the use of mepolizumab during pregnancy. All patients with severe asthma will be qualified for treatment with mepolizumab in accordance with GINA guidelines.

You may not qualify if:

• Patients less than 18 years of age, subjects suffering from COPD, known or suspected immunodeficiency or autoimmune disease, chronic interstitial lung diseases, cystic fibrosis, individuals exposed to systemic corticosteroid/immunosuppressive treatments, biologics for asthma care or antibiotics within the previous 3 months before mepolizumab administration, active smokers and obese individuals will be excluded from this study. Pregnant women will not be included into the study because of the potential changes that their microbiome and other host parameters could undergo during pregnancy. The control group will comprise healthy volunteers who will be free from CRS, asthma, and atopy.

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (2)

Pulmonary Dept First ICU, Evagelismos Hospital

Athens, Attica, 10676, Greece

Location

Pulmonary Dept First ICU Evangelismos Hospital

Athens, 10676, Greece

Location

Related Publications (15)

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  PMID: 17283555 BACKGROUND

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Biospecimen

Retention: SAMPLES WITH DNA

Sputum blood and nasal samples

MeSH Terms

Conditions

Pulmonary Eosinophilia; Nasal Polyps

Interventions

mepolizumab

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypereosinophilic Syndrome; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Nose Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Paraskevi Katsaounou, MD, PhD, Msc

  National and Kapodistrian University of Athens

  PRINCIPAL INVESTIGATOR

• Eleni Loutrari, PhD

  National and Kapodistrian University of Athens

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Respiratory Medicine

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: October 5, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

GR (2)