NCT07592104Completed
Effectiveness on Sino-Nasal Symptoms Of Mepolizumab 300
Effectiveness on Sino-Nasal Symptoms Of Mepolizumab 300 In Patients Affected by Egpa and Concomitant Severe and Uncontrolled CRSwNP: Italian Multicentric "Real-Life" Observational Study
Source: ClinicalTrials.gov · Last updated 18 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 52 (actual)
- First submitted
- 25 Aug 2025
- Start date
- 12 Sept 2025
- Primary completion date
- 20 Dec 2025
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- ANCA-associated vasculitis
- NCT number
- NCT07592104
What you commit to
- Study type: Observational
- Participants enrolled: 52
- From 12 Sept 2025 to the primary completion date, 20 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients undergoing radio/chemotherapy treatments for cancer in the 12 months before the start of therapy.
Other illness
- Patients with EGPA with organ impairment or at risk of death;
Age
- Age \<18 years;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Policlinico Universitario A. Gemelli IRCCS Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.