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

Chronic Rhinosinusitis With Nasal Polyps Clinical Trial

— MEPOREAL  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06258772
• Other study ID #: 6231
• Status: Not yet recruiting
• Start date: February 5, 2024
• Est. completion date: February 1, 2026

Study information

• Verified date: February 2024
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 199
• Est. completion date: February 1, 2026
• Est. primary completion date: February 1, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Rhinosinusitis With Nasal Polyps
• Nasal Polyps

Intervention

Drug:
• Mepolizumab Auto-Injector
Mepolizumab 100 mg in pre-filled injector

Locations

Country	Name	City	State
Italy	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	Firenze
Italy	Ospedale Policlinico San Martino,	Genova
Italy	Ospedale Vito Fazzi, ASL Lecce	Lecce
Italy	ASST Santi Paolo e Carlo	Milano
Italy	IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milano
Italy	IRCCS Ospedale San Raffaele	Milano
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	Padova
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

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nasal Polyp Score	Evaluation of polyps volume from 0 (minimum) to 4 (maximum) points for each nasal cavity. Reduced score indicates improvement	24 months
Primary	Sinonasal Outcome Test - 22	Questionnaire measuring health-related quality of life. The score is from 0 (minimum) to 110 (maximum). Reduced score indicates improvement	24 months
Secondary	Visual Analogue Scale for nasal obstruction	Evaluation of nasal obstruction from 0 (minimum) to 10 (maximum) ;reduced score indicates improvement	24 moths
Secondary	Nasal Congestion Score (NCS); score (range 0-3);	Evaluation of nasal congestion educed score indicates improvement	24 months
Secondary	Visual Analogue Scale for smell	Evaluation of olfaction impairment from 0 (minimum) to 10 (maximum); reduced score indicates improvement	24 months
Secondary	Sniffing sticks identification test	Test of nasal chemosensory performance based on pen-like odor dispensing devices. From 0 (minimum ) to 16 (maximum); increased score indicates improvement.	24 months
Secondary	Change in blood eosinophil count	Change in blood eosinophil count in a complete blood count (CBC)	24 months
Secondary	Adherence to drug therapy with Mepolizumab	Number of missing injection in a year	24 months
Secondary	Need for rescue oral corticosteroids	Number of oral corticosteroids cycles during therapy	24 months
Secondary	Need for surgery	Number of surgeries performed during therapy	24 months