Mepolizumab in the Treatment of Patients With Severe Uncontrolled CRSwNP: a Multicentric Real Life Observational Study
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Interventions
- Registration Number
- NCT06258772
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 199
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Severe, uncontrolled CRSwNP patients in therapy with Mepolizumab Mepolizumab Auto-Injector -
- Primary Outcome Measures
Name Time Method Nasal Polyp Score 24 months Evaluation of polyps volume from 0 (minimum) to 4 (maximum) points for each nasal cavity. Reduced score indicates improvement
Sinonasal Outcome Test - 22 24 months Questionnaire measuring health-related quality of life. The score is from 0 (minimum) to 110 (maximum). Reduced score indicates improvement
- Secondary Outcome Measures
Name Time Method Adherence to drug therapy with Mepolizumab 24 months Number of missing injection in a year
Need for rescue oral corticosteroids 24 months Number of oral corticosteroids cycles during therapy
Need for surgery 24 months Number of surgeries performed during therapy
Change in blood eosinophil count 24 months Change in blood eosinophil count in a complete blood count (CBC)
Visual Analogue Scale for nasal obstruction 24 moths Evaluation of nasal obstruction from 0 (minimum) to 10 (maximum) ;reduced score indicates improvement
Nasal Congestion Score (NCS); score (range 0-3); 24 months Evaluation of nasal congestion educed score indicates improvement
Visual Analogue Scale for smell 24 months Evaluation of olfaction impairment from 0 (minimum) to 10 (maximum); reduced score indicates improvement
Sniffing sticks identification test 24 months Test of nasal chemosensory performance based on pen-like odor dispensing devices. From 0 (minimum ) to 16 (maximum); increased score indicates improvement.
Trial Locations
- Locations (27)
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
IRCCS Ospedale San Raffaele
🇮🇹Milano, Italy
Azienda Ospedaliera Universitaria San Luigi Gonzaga,
🇮🇹Orbassano (TO), Italy
ASST Santi Paolo e Carlo
🇮🇹Milano, Italy
IRCCS Ca' Granda Ospedale Maggiore Policlinico
🇮🇹Milano, Italy
Azienda ospedaliera policlinico Federico II di Napoli
🇮🇹Napoli, Italy
Ospedale Maggiore della Carità di Novara,
🇮🇹Novara, Italy
Fondazione I.R.C.C.S. Policlinico San Matteo
🇮🇹Pavia, Italy
Azienda USL - IRCCS di Reggio Emilia
🇮🇹Reggio Emilia, Italy
Azienda Ospedaliera Università di Padova
🇮🇹Padova, Italy
Azienda Ospedaliero-Universitaria Pisana - Pisa
🇮🇹Pisa, Italy
Fondazione Policlinico Universitario A.Gemelli IRCCS
🇮🇹Roma, Italy
Azienda Ospedaliera San Camillo-Forlanini
🇮🇹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
Azienda Ospedaliero-Universitaria di Modena - Modena
🇮🇹Modena, Italy
ASST sette laghi Varese,
🇮🇹Varese, Italy