Treatment With Mepolizumab on Patients With Severe Refractory Eosinophilic Asthma (NCT05063981) | Clinical Trial Compass
CompletedNot Applicable
Treatment With Mepolizumab on Patients With Severe Refractory Eosinophilic Asthma
Italy15 participantsStarted 2021-11-25
Plain-language summary
Understanding how Interleukin-5 blockade modulates both immune and metabolic pathways may clarify the multidimensional impact of biologic therapy in severe eosinophilic asthma. Therefore, this study aimed to assess the impact of mepolizumab on the nasal, bronchial, and systemic metabolomic profiles of consecutive patients with SEA and to explore the associations between these compartment-specific changes and clinical, inflammatory, and functional outcomes.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Eligibility for mepolizumab treatment according to clinical practice;
* age between 18 and 75 years;
* diagnosis of severe eosinophilic refractory asthma, defined as peripheral blood eosinophil count (BEC) \> 300 cells/μL and at least two documented exacerbations within the previous 12 months;
* ongoing treatment with high daily doses of inhaled corticosteroids (ICS) combined with long-acting β2-agonists (LABA), plus at least one additional controller medication for a minimum of 12 months.
Exclusion criteria:
* current smoking;
* diagnosis of other chronic pulmonary diseases;
* coexisting chronic rhinosinusitis with nasal polyps;
* use of systemic corticosteroids at any dose within the 6 weeks prior to enrollment;
* use of immunosuppressive therapies;
* receipt of live attenuated vaccines within 30 days prior to enrollment;
* current or recent history (within the last 5 years) of malignancy, except in cases of complete remission;
* diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA);
* upper or lower respiratory tract infections within 30 days prior to signing informed consent or during the screening/run-in period;
* any clinically significant abnormalities identified during screening through physical examination, vital signs assessment, hematology, or clinical chemistry, which, in the opinion of the investigator, could pose a risk to patient safety or interfere with study outcomes or compliance.
* known immunodeficiency (primary or seco…