Chronic Rhinosinusitis With Nasal PolypsMEPOREALNCT06258772
Mepolizumab in the Treatment of Patients With Severe Uncontrolled CRSwNP: a Multicentric Real Life Observational Study
An observational study of Chronic Rhinosinusitis With Nasal Polyps, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 27 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps
- What is being tested?
- Mepolizumab Auto-Injector
- How many people
- 199 participants
- Where
- 27 sitesItaly
- Study dates
- 5 Feb 2024to 1 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: We included all patients that were referred to Mepolizumab therapy, prescribed accordingly to the plan provided by AIFA
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
Italy27 sites
Ospedali PO di Venere e San Paolo
Bari
Policlinico Universitario di Bari, Ospedale Giovanni XXIII,
Bari
AUSL Bologna
Bologna
ASST degli spedali civili di Brescia,
Brescia
Azienda Ospedaliero Universitaria Policlinico - S. Marco,
Catania
Azienda Ospedaliero Universitaria Careggi
Florence
Ospedale Policlinico San Martino,
Genova
Ospedale Vito Fazzi, ASL Lecce
Lecce
ASST Santi Paolo e Carlo
Milan
Carlotta Pipolo
IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan
IRCCS Ospedale San Raffaele
Milan
Azienda Ospedaliero-Universitaria di Modena - Modena
Modena
Daniela Lucidi
Azienda ospedaliera policlinico Federico II di Napoli
Naples
Ospedale Maggiore della Carità di Novara,
Novara
Azienda Ospedaliera Universitaria San Luigi Gonzaga,
Orbassano (TO)
Azienda Ospedaliera Università di Padova
Padova
Fondazione I.R.C.C.S. Policlinico San Matteo
Pavia
Fabio Pagella
Azienda Ospedaliero-Universitaria Pisana - Pisa
Pisa
Azienda USL - IRCCS di Reggio Emilia
Reggio Emilia
Azienda Ospedaliera San Camillo-Forlanini
Roma
Fondazione Policlinico Universitario A.Gemelli IRCCS
Roma
Eugenio De Corso, 0630154439, eugenio.decorso@policlinicogemelli.it
Ospedaliero- Universitaria Policlinico Umberto I
Roma
Policlinico Tor Vergata: Fondazione PTV
Roma
Presidio Ospedaliero San Filippo Neri,
Roma
Azienda Ospedaliero- Universitaria Senese
Siena
i ASL ROMA 5 - Distretto Sanitario di Tivoli
Tivoli
ASST sette laghi Varese,
Varese
About this study
Official title: Effectiveness of Mepolizumab in the Treatment of Patients With Severe Uncontrolled CRSwNP: a Multicentric Real Life Observational Study
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.
Read more
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
- Being tested
- Mepolizumab Auto-Injector
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mepolizumab Auto-InjectorDrug
Also called Mepolizumab 100 mg
Mepolizumab 100 mg in pre-filled injector
| Study group | Role | What they receive |
|---|---|---|
| Severe, uncontrolled CRSwNP patients in therapy with Mepolizumab | Not described Receives: Drug: Mepolizumab Auto-Injector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal Polyp Score
Evaluation of polyps volume from 0 (minimum) to 4 (maximum) points for each nasal cavity. Reduced score indicates improvement
Measured: 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
Measured: 24 months
Secondary outcomes (8)
Visual Analogue Scale for nasal obstruction
Evaluation of nasal obstruction from 0 (minimum) to 10 (maximum) ;reduced score indicates improvement
Measured: 24 moths
Nasal Congestion Score (NCS); score (range 0-3);
Evaluation of nasal congestion educed score indicates improvement
Measured: 24 months
Visual Analogue Scale for smell
Evaluation of olfaction impairment from 0 (minimum) to 10 (maximum); reduced score indicates improvement
Measured: 24 months
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.
Measured: 24 months
Change in blood eosinophil count
Change in blood eosinophil count in a complete blood count (CBC)
Measured: 24 months
Adherence to drug therapy with Mepolizumab
Number of missing injection in a year
Measured: 24 months
Need for rescue oral corticosteroids
Number of oral corticosteroids cycles during therapy
Measured: 24 months
Need for surgery
Number of surgeries performed during therapy
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start5 Feb 2024 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Rhinosinusitis With Nasal PolypsStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 199 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DE CORSO EUGENIO, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06258772
- Sponsor's protocol ID
- 6231
- Acronym
- MEPOREAL
- Status last verified
- Feb 2024
- First submitted
- 2 Feb 2024
- Last updated
- 14 Feb 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
De Corso E, Ottaviano G, Seccia V, Pipolo C, Canevari FRM, Maggiore G, Cantone E, Pagella F, Anastasi F, Pasquini E, Torretta S, Garzaro M, Gallo S, Loperfido A, D'Ascanio L, Moffa A, Cavaliere C, Caruso M, Anzivino R, Fadda G, Passali FM, Iannuzzi L, Urbanelli A, Tomacelli GL, Poma S, Corbo M, Montuori C, D'Auria LM, Galli J, La Mantia I; ENT Biologic Italian study group (PolyData Forum). Mepolizumab effectiveness for patients with severe, uncontrolled chronic rhinosinusitis with nasal polyps in Italy (MEPOREAL): a real-life, multicentre, phase 4 trial. Lancet Respir Med. 2026 Aug 18:S2213-2600(26)00197-9. doi: 10.1016/S2213-2600(26)00197-9. Online ahead of print.
PubMed 42612655
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mepolizumab in the Treatment of Patients With Severe Uncontrolled CRSwNP: a Multicentric Real Life Observational Study
- ClinicalTrials.gov ID
- NCT06258772
- Acronym / sponsor ID
- MEPOREAL / 6231
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 199 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 5 Feb 2024 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe, uncontrolled CRSwNP patients in therapy with Mepolizumab | – | Drug: Mepolizumab Auto-Injector |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- We included all patients that were referred to Mepolizumab therapy, prescribed accordingly to the plan provided by AIFA
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mepolizumab Auto-InjectorAlso: Mepolizumab 100 mgMepolizumab 100 mg in pre-filled injector | Drug | Severe, uncontrolled CRSwNP patients in therapy with Mepolizumab |
Primary outcome
Nasal Polyp Score
Time frame: 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
Time frame: 24 months
Questionnaire measuring health-related quality of life. The score is from 0 (minimum) to 110 (maximum). Reduced score indicates improvement
8 secondary outcomes
Visual Analogue Scale for nasal obstruction
Time frame: 24 moths
Nasal Congestion Score (NCS); score (range 0-3);
Time frame: 24 months
Visual Analogue Scale for smell
Time frame: 24 months
Sniffing sticks identification test
Time frame: 24 months
Change in blood eosinophil count
Time frame: 24 months
Adherence to drug therapy with Mepolizumab
Time frame: 24 months
Need for rescue oral corticosteroids
Time frame: 24 months
Need for surgery
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Derived from this study: PubMed 42612655De Corso E, Ottaviano G, Seccia V, Pipolo C, Canevari FRM, Maggiore G, Cantone E, Pagella F, Anastasi F, Pasquini E, Torretta S, Garzaro M, Gallo S, Loperfido A, D'Ascanio L, Moffa A, Cavaliere C, Caruso M, Anzivino R, Fadda G, Passali FM, Iannuzzi L, Urbanelli A, Tomacelli GL, Poma S, Corbo M, Montuori C, D'Auria LM, Galli J, La Mantia I; ENT Biologic Italian study group (PolyData Forum). Mepolizumab effectiveness for patients with severe, uncontrolled chronic rhinosinusitis with nasal polyps in Italy (MEPOREAL): a real-life, multicentre, phase 4 trial. Lancet Respir Med. 2026 Aug 18:S2213-2600(26)00197-9. doi: 10.1016/S2213-2600(26)00197-9. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fondazione Policlinico Universitario A.Gemelli IRCCS
Roma, Italy
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Rhinosinusitis With Nasal Polyps, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 27 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal Polyp Score (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06258772, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.