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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.