Mepolizumab in the Treatment of Patients With Severe Uncontrolled CRSwNP: a Multicentric Real Life Observational Study

NCT ID: NCT06258772

Last Updated: 2024-02-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 199 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-05
• Study Completion Date: 2026-02-01

Brief Summary

Chronic rhinosinusitis with nasal polyposis (CRSwNP) is a complex chronic inflammatory disease of the nasosinusal mucosa that has a significant negative impact on patients' quality of life.

In CRSwNP, chronic inflammation is primarily driven by type 2 pro-inflammatory interleukins (ILs )such as IL-5, IL-4, and IL-13 along- side high levels of eosinophils in the surrounding tissue. Mepolizumab is a targeted, humanized anti-IL-5 antibody that prevents IL-5 from binding to its receptor on eosinophils and selectively inhibits eosinophilic inflammation.

So far, randomized clinical trials have assessed efficacy and safety of Mepolizumab in a large number of patients, whereas evidences in real life clinical practice are limited to few monocentric series.

Herewith, we present a multicenter, observational, prospective/retrospective nationwide real-life study with the aim to confirm the effectiveness and the safety of Mepolizumab over the first year of treatment in a real life setting.

The primary objective of this study is to evaluate the reduction of dimension of nasal polyps and the improvement of quality of life in the patient measured through symptomatologic questionnaires.

The secondary objective is to evaluate improvements in terms of smell dysfunction, comorbidities, biomarkers (nasal cytology and blood eosinophilia), need of surgery or systemic steroids.

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Severe, uncontrolled CRSwNP patients in therapy with Mepolizumab

Mepolizumab Auto-Injector

Intervention Type: DRUG

Mepolizumab 100 mg in pre-filled injector

Interventions

Mepolizumab Auto-Injector

Mepolizumab 100 mg in pre-filled injector

Intervention Type: DRUG

Other Intervention Names

Mepolizumab 100 mg

Eligibility Criteria

Inclusion Criteria

• Patients over 18 years of age who can sign a written informed consent 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;
• Blood eosinophils >150
• Severe disease stage, defined by Nasal Polyp Score (NPS) ≥ 5 or nasal obstruction symptom visual analogue scale (VAS) score of >5 and/or Sinonasal outcome tests-22 (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) and failure of previous surgical treatment through nasal endoscopic surgery (FESS), with no clinical benefit or postoperative complications.

Exclusion Criteria

• Age <18 years;
• Patients undergoing immunosuppressive therapies;
• Patients undergoing radio/chemotherapy treatments for cancer in the 12 months before the start of therapy;
• Patients on concomitant long-term corticosteroid therapy for chronic autoimmune disorders.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

DE CORSO EUGENIO

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ospedali PO di Venere e San Paolo

Bari, , Italy

Policlinico Universitario di Bari, Ospedale Giovanni XXIII,

Bari, , Italy

AUSL Bologna

Bologna, , Italy

ASST degli spedali civili di Brescia,

Brescia, , Italy

Azienda Ospedaliero Universitaria Policlinico - S. Marco,

Catania, , Italy

Azienda Ospedaliero Universitaria Careggi

Florence, , Italy

Ospedale Policlinico San Martino,

Genova, , Italy

Ospedale Vito Fazzi, ASL Lecce

Lecce, , Italy

ASST Santi Paolo e Carlo

Milan, , Italy

IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, , Italy

IRCCS Ospedale San Raffaele

Milan, , Italy

Azienda Ospedaliero-Universitaria di Modena - Modena

Modena, , Italy

Azienda ospedaliera policlinico Federico II di Napoli

Napoli, , Italy

Ospedale Maggiore della Carità di Novara,

Novara, , Italy

Azienda Ospedaliera Universitaria San Luigi Gonzaga,

Orbassano (TO), , Italy

Azienda Ospedaliera Università di Padova

Padua, , Italy

Fondazione I.R.C.C.S. Policlinico San Matteo

Pavia, , Italy

Azienda Ospedaliero-Universitaria Pisana - Pisa

Pisa, , Italy

Azienda USL - IRCCS di Reggio Emilia

Reggio Emilia, , Italy

Azienda Ospedaliera San Camillo-Forlanini

Roma, , Italy

Fondazione Policlinico Universitario A.Gemelli IRCCS

Roma, , Italy

Ospedaliero- Universitaria Policlinico Umberto I

Roma, , Italy

Policlinico Tor Vergata: Fondazione PTV

Roma, , Italy

Presidio Ospedaliero San Filippo Neri,

Roma, , Italy

Azienda Ospedaliero- Universitaria Senese

Siena, , Italy

i ASL ROMA 5 - Distretto Sanitario di Tivoli

Tivoli, , Italy

ASST sette laghi Varese,

Varese, , Italy

Countries

Italy

Facility Contacts

Carlotta Pipolo

Role: primary

Daniela Lucidi

Role: primary

Fabio Pagella

Role: primary

Eugenio De Corso

Role: primary

eugenio.decorso@policlinicogemelli.it

0630154439

Other Identifiers

6231

Identifier Type: -

Identifier Source: org_study_id