Treatment With Mepolizumab on Patients With Severe Refractory Eosinophilic Asthma With or Without CRSwNP.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| CRSwNP 10 patients with severe refractory eosinophilic asthma plus CRSwNP |
Drug: 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
Other Names:
|
| No CRSwNP 10 patients with severe refractory eosinophilic asthma and no CRSwNP |
Drug: 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
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Pulmonary function tests [2 years]
by the helium dilution method
- Nasal cytology [2 years]
mediator evaluations
- Induced sputum [2 years]
high sensitive tests ELISA
- Exhaled NO [2 years]
measurement of FeNO
- Inflammatory markers [2 years]
ELISA test
- EBC sampling [2 years]
α-amylase activity
- NMR-based metabolomics [2 years]
NMR spectroscopy
Eligibility Criteria
Criteria
Inclusion Criteria:age >18 years
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diagnosis of severe refractory asthma according to the ERS/ATS criteria ATS
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Blood eosinophils >150 cells/mcL at the screening visit and at least one value of 300 or more eosinophils/mcL during the previous year;
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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
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written informed consent.
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For CRSwNP diagnosis, the EPOS 2020 guidelines will be considered as reference. All the above-mentioned inclusion criteria must be met.
Exclusion Criteria:Pregnancy
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Eosinophilic Granulomatosis with Polyangiitis (EGPA);
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Serious life threatening cardiopulmonary disorders;
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Systemic immunologic disorder in the last 12 months;
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Positive history for malignant tumors ever in patient's life;
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Immunodeficiency.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Istituti Clinici Scientifici Maugeri IRCCS | Telese Terme | BN | Italy | 82037 |
Sponsors and Collaborators
- Istituti Clinici Scientifici Maugeri SpA
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- icsmaugeri