Effectiveness on Sino-Nasal Symptoms Of Mepolizumab 300

NCT07592104 | Completed FDA Drug

• 1 other identifier: 7715
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sinus Disease; EGPA - Eosinophilic Granulomatosis With Polyangiitis; Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps

Outcome Measures

Primary Outcomes (1)

• the Improvement of NPS score

  The primary endpoints will be the Improvement of NPS score (indicative of polyps score reduction) at 12 months after start of therapy. The nasal polyp score is a quantitative assessment ranging from 0 to 4 for each nostril. The sum of the bilateral scores provides a composite total score ranging from 0 to 8.

  12 months

Interventions

Mepolizumab 300 mg DRUG

Mepolizumab 300 mg subcutaneous every 4 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will collect data from patients affected by EGPA and concomitant severe chronic rhinosinusitis with nasal polyps (CRSwNP) not controlled by local and systemic corticosteroids and/or surgery, who have received indication, during normal clinical practice, to therapy with Mepolizumab 300mg every 4 weeks (self-administered at home with subcutaneous autoinjector), in addition to topical nasal corticosteroids. For the retrospective cohort, the start of observation is from 01 March 2023 We be enrolled 52 patients.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, Roma, 00168, Italy

Location

MeSH Terms

Conditions

Paranasal Sinus Diseases; Churg-Strauss Syndrome

Interventions

mepolizumab

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Granuloma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Eugenio De Corso

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: May 18, 2026
• Study Start: September 12, 2025
• Primary Completion: December 20, 2025
• Study Completion: March 23, 2026
• Last Updated: May 18, 2026

Record last verified: 2026-05

Locations

IT (1)