Clinical trial NCT05063981: Treatment With Mepolizumab on Patients With Severe Refractory Eosinophilic Asthma With or Without CRSwNP.
Official title: Biomarkers Evaluation and Effect of Mepolizumab on Lower and Upper Airways Inflammation in Severe Refractory Eosinophilic Asthma and Nasal Polyposis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Asthma
Nasal Polyps
Sinusitis Chronic
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
First posted: 2021-10-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We will enroll 10 patients with severe refractory eosinophilic asthma plus CRSwNP and 10 patients with severe refractory eosinophilic asthma and no CRSwNP, for whom treatment with mepolizumab is indicated, according to the AIFA recommendations.

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.

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.

Primary outcomes:
measure: Pulmonary function tests
timeFrame: 2 years
measure: Nasal cytology
timeFrame: 2 years
measure: Induced sputum
timeFrame: 2 years
measure: Exhaled NO
timeFrame: 2 years
measure: Inflammatory markers
timeFrame: 2 years
measure: EBC sampling
timeFrame: 2 years
measure: NMR-based metabolomics
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Telese Terme
country: Italy
facility: Istituti Clinici Scientifici Maugeri IRCCS
state: BN
Study officials:
References: