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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05063981
• Other study ID #: icsmaugeri
• Status: Recruiting
• Start date: November 25, 2021
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Istituti Clinici Scientifici Maugeri SpA
• Contact: Mauro Maniscalco, MD
• Phone: +390824909350
• Email: mauro.maniscalco[@]icsmaugeri.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Nasal Polyps
• Pulmonary Eosinophilia
• Sinusitis
• Sinusitis Chronic

Intervention

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

Locations

Country	Name	City	State
Italy	Istituti Clinici Scientifici Maugeri IRCCS	Telese Terme	BN

Sponsors (1)

Lead Sponsor	Collaborator
Istituti Clinici Scientifici Maugeri SpA

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary function tests	by the helium dilution method	2 years
Primary	Nasal cytology	mediator evaluations	2 years
Primary	Induced sputum	high sensitive tests ELISA	2 years
Primary	Exhaled NO	measurement of FeNO	2 years
Primary	Inflammatory markers	ELISA test	2 years
Primary	EBC sampling	a-amylase activity	2 years
Primary	NMR-based metabolomics	NMR spectroscopy	2 years