Treatment With Mepolizumab on Patients With Severe Refractory Eosinophilic Asthma With or Without CRSwNP.

Recruiting

• Conditions: Sinusitis Chronic; Nasal Polyps; Asthma
• Interventions: Drug: Mepolizumab

• Registration Number: NCT05063981
• Lead Sponsor: Istituti Clinici Scientifici Maugeri SpA

Brief Summary

Patients with severe or difficult-to-treat asthma represent a small amount of total asthmatic patients, but weight on the national health system for the costs of disease management. Chronic rhinosinusitis with nasal polyposis, which the Italian severe/uncontrolled asthma registry reported with a prevalence of 30%, represents a comorbidity that significantly impact lung function and asthma control in severe asthma. Recent evidence indicates that there is a consistent heterogeneity regarding mucosal alterations present in subjects with nasal polyposis involving different pathways: inflammatory cells, remodeling, T cell activation, local IgE production, alteration induced by interactions between microorganisms and epithelial cells.

Detailed Description

Nasal, bronchial and systemic inflammation can differ among patients with severe refractory eosinophilic asthma with or without CRSwNP. Treatment with Mepolizumab could modify nasal, bronchial and systemic inflammation of patients with severe refractory eosinophilic asthma and nasal polyposis acting on disease control.

Study Timeline

• Study First Submitted: 2021-07-15
• Study First Submitted QC: 2021-09-21
• Study First Posted: 2021-10-01
• Study Start: 2021-11-25
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-04
• Last Update Posted: 2023-12-11
• Primary Completion: 2024-11
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

age >18 years

• diagnosis of severe refractory asthma according to the ERS/ATS criteria ATS
• Blood eosinophils >150 cells/mcL at the screening visit and at least one value of 300 or more eosinophils/mcL during the previous year;
• at least two exacerbations despite maximal therapy with long-acting bronchodilators and high dose inhaled corticosteroids in the previous year or the need for continued therapy with oral corticosteroids in addition to maximal inhaled therapy for at least 6 months in the previous year
• written informed consent.
• For CRSwNP diagnosis, the EPOS 2020 guidelines will be considered as reference. All the above-mentioned inclusion criteria must be met.

Exclusion Criteria

Pregnancy

• Eosinophilic Granulomatosis with Polyangiitis (EGPA);
• Serious life threatening cardiopulmonary disorders;
• Systemic immunologic disorder in the last 12 months;
• Positive history for malignant tumors ever in patient's life;
• Immunodeficiency.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No CRSwNP	Mepolizumab	10 patients with severe refractory eosinophilic asthma and no CRSwNP
CRSwNP	Mepolizumab	10 patients with severe refractory eosinophilic asthma plus CRSwNP

Primary Outcome Measures

Name	Time	Method
Exhaled NO	2 years	measurement of FeNO
Nasal cytology	2 years	mediator evaluations
Induced sputum	2 years	high sensitive tests ELISA
Inflammatory markers	2 years	ELISA test
EBC sampling	2 years	α-amylase activity
NMR-based metabolomics	2 years	NMR spectroscopy
Pulmonary function tests	2 years	by the helium dilution method

Trial Locations

Locations (1)

Istituti Clinici Scientifici Maugeri IRCCS; 🇮🇹 Telese Terme, BN, Italy