Effectiveness on Sino-Nasal Symptoms Of Mepolizumab 300 (NCT07592104) | Clinical Trial Compass
CompletedNot Applicable
Effectiveness on Sino-Nasal Symptoms Of Mepolizumab 300
Italy52 participantsStarted 2025-09-12
Plain-language summary
OBJECTIVES The primary objective of this study is evaluating the reduction of dimension of nasal polyps measured with Nasal Polyp Endoscopic Score (NPS) The secondary objective is to evaluate the improvement in nasal symptoms and quality of life in the patient measured through symptom questionnaires, the improvements in terms of smell dysfunction and symptomatology related to eosinophilic otitis media;evaluate the need of surgery or systemic corticosteroids.
ENDPOINTS Primary endpoint The primary endpoints will be the Improvement of NPS score (indicative of polyps score reduction) at 12 months after start of therapy.
Secondary endpoints
* Improvement of SNOT-22 score (indicative of an improvement in quality of life)
* Improvement of VAS score for nasal obstruction
* Improvement of Nasal Congestion Score (NCS)
* Improvement of VAS score for smell;
* Improvement of sniffin' sticks score;
* Evaluate adherence to drug therapy with Mepolizumab 300, any suspension of the same and reasons for discontinuing treatment (lack of efficacy, complications reported, safety profile);
* Assess how many patients require FESS surgery and/or systemic steroids for sino-nasal symptoms during treatment;
* Evaluate the improvement of symptoms of any associated comorbidities and in particular chronic eosinophilic otitis media.
Study design Observational, retrospective/prospective, non-profit and national multicenter real-life study.
Who can participate
Age range
18 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
Eligible patients will be:
* Patients over 18 years of age who can sign a written informed consent;
* Confirmed diagnosis of EGPA by rheumatologist and in treatment with Mepolizumab 300 mg every 4 weeks, according to clinical pratice;
* Confirmed clinical / radiological diagnosis of chronic rhinosinusitis with diffuse naso-sinusal polyposis by nasal endoscopy and/or massive facial CT scan without contrast medium carried out within 6 months prior to the start of therapy;
* Severe disease stage, defined by Nasal Polyp Score (NPS) ≥ 5 or nasal obstruction symptom visual analogue scale (VAS) score of \>5 and/or SNOT-22 ≥ 50);
* Inadequate symptom control with intranasal local corticosteroid therapy;
* Failure of previous medical treatments (at least 2 cycles in the last year of systemic corticosteroid) or failure of previous surgical treatment through nasal endoscopic surgery (FESS), with no clinical benefit or postoperative complications.
Exclusion criteria
* Age \<18 years;
* Patients with EGPA with organ impairment or at risk of death;
* Patients undergoing radio/chemotherapy treatments for cancer in the 12 months before the start of therapy.
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.