Clinical trial

Biomarkers Evaluation and Effect of Mepolizumab on Lower and Upper Airways Inflammation in Severe Refractory Eosinophilic Asthma and Nasal Polyposis

Name

icsmaugeri

Description

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.

Trial arms

Trial start

2021-11-25

Estimated PCD

2024-11-01

Trial end

2024-12-01

Status

Recruiting

Treatment

Mepolizumab

Treatment with Mepolizumab could modify nasal, bronchial and systemic inflammation of patients with severe refractory eosinophilic asthma and nasal polyposis acting on disease control

Arms:

CRSwNP, No CRSwNP

Other names:

Nucala

Size

Primary endpoint

Pulmonary function tests

2 years

Nasal cytology

2 years

Induced sputum

2 years

Exhaled NO

2 years

Inflammatory markers

2 years

EBC sampling

2 years

NMR-based metabolomics

2 years

Eligibility criteria

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.

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'ECOLOGIC_OR_COMMUNITY', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

Updated at

2023-12-11

1 organization

1 product

3 indications

Organization

Istituti Clinici Scientifici Maugeri

Product

Indication

Indication

Indication