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

NCT06258772 | Not Yet Recruiting FDA Drug

• 1 other identifier: 6231
• Study Type: observational
• Target: 199
• Locations: 1 country
• Sites: 27

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

Outcome Measures

Primary Outcomes (2)

• Nasal Polyp Score

  Evaluation of polyps volume from 0 (minimum) to 4 (maximum) points for each nasal cavity. Reduced score indicates improvement

  24 months

• 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 Outcomes (8)

• Visual Analogue Scale for nasal obstruction

  24 moths

• Nasal Congestion Score (NCS); score (range 0-3);

  24 months

• Visual Analogue Scale for smell

  24 months

• Sniffing sticks identification test

  24 months

• Change in blood eosinophil count

  24 months

Study Arms (1)

Severe, uncontrolled CRSwNP patients in therapy with Mepolizumab

Drug: Mepolizumab Auto-Injector

Interventions

Mepolizumab Auto-Injector DRUG

Mepolizumab 100 mg in pre-filled injector

Also known as: Mepolizumab 100 mg

Severe, uncontrolled CRSwNP patients in therapy with Mepolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We included all patients that were referred to Mepolizumab therapy, prescribed accordingly to the plan provided by AIFA

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (27)

Ospedali PO di Venere e San Paolo

Bari, Italy

Location

Policlinico Universitario di Bari, Ospedale Giovanni XXIII,

Bari, Italy

Location

AUSL Bologna

Bologna, Italy

Location

ASST degli spedali civili di Brescia,

Brescia, Italy

Location

Azienda Ospedaliero Universitaria Policlinico - S. Marco,

Catania, Italy

Location

Azienda Ospedaliero Universitaria Careggi

Florence, Italy

Location

Ospedale Policlinico San Martino,

Genova, Italy

Location

Ospedale Vito Fazzi, ASL Lecce

Lecce, Italy

Location

ASST Santi Paolo e Carlo

Milan, Italy

Location

IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

Location

IRCCS Ospedale San Raffaele

Milan, Italy

Location

Azienda Ospedaliero-Universitaria di Modena - Modena

Modena, Italy

Location

Azienda ospedaliera policlinico Federico II di Napoli

Napoli, Italy

Location

Ospedale Maggiore della Carità di Novara,

Novara, Italy

Location

Azienda Ospedaliera Universitaria San Luigi Gonzaga,

Orbassano (TO), Italy

Location

Azienda Ospedaliera Università di Padova

Padua, Italy

Location

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

Pavia, Italy

Location

Azienda Ospedaliero-Universitaria Pisana - Pisa

Pisa, Italy

Location

Azienda USL - IRCCS di Reggio Emilia

Reggio Emilia, Italy

Location

Azienda Ospedaliera San Camillo-Forlanini

Roma, Italy

Location

Fondazione Policlinico Universitario A.Gemelli IRCCS

Roma, Italy

Location

Ospedaliero- Universitaria Policlinico Umberto I

Roma, Italy

Location

Policlinico Tor Vergata: Fondazione PTV

Roma, Italy

Location

Presidio Ospedaliero San Filippo Neri,

Roma, Italy

Location

Azienda Ospedaliero- Universitaria Senese

Siena, Italy

Location

i ASL ROMA 5 - Distretto Sanitario di Tivoli

Tivoli, Italy

Location

ASST sette laghi Varese,

Varese, Italy

Location

MeSH Terms

Interventions

mepolizumab

Study Design

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

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 14, 2024
• Study Start: February 5, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2026
• Last Updated: February 14, 2024

Record last verified: 2024-02

Locations

IT (27)