Dupilumab in the Treatment of Severe Uncontrolled CRSwNP: a Multicentre Observational Real-life Study (DUPIREAL)

NCT ID: NCT05529784

Last Updated: 2023-02-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-06
• Study Completion Date: 2023-10-01

Brief Summary

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) is a sino-nasal chronic inflammatory disease that strongly affects patients' quality of life, especially in difficult-to-treat cases. In severe uncontrolled CRSwNP, the inflammation is mostly driven by a type 2 inflammatory pathway and its management has been rapidly changing during the last 2 years due to Dupilumab approval. It is a fully human monoclonal antibody that binds the alpha subunit of IL-4 receptors (IL-4Rα type 1 and type 2) to inhibit IL-4 and IL-13 signaling.

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

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

The primary objective is to evaluate the volumetric reduction of polyps by measuring the variation of total Nasal Polyp Endoscopic Score (NPS).

The secondary objectives are:

• the evaluation of changes in nasal symptoms, olfactory function and nasal obstruction
• the assessment of the patients' quality of life
• the recording of major and minor complications
• the evaluation of the response to the therapy, according to EPOS2020 criteria and EUFOREA2021
• the assessment of efficacy based on concomitant disease (Asthma and ASA triad)
• the evaluation of potential predictors of clinical response to the therapy

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Study Design

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

Study Groups

Severe, uncontrolled CRSwNP patients in therapy with Dupilumab

Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]

Intervention Type: DRUG

Dupilumab 300mg in pre-filled injector Q2W

Interventions

Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]

Dupilumab 300mg in pre-filled injector Q2W

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• confirmed diagnosis of diffuse CRSwNP by endoscopy and CT scan performed at least 6 months prior of the therapy;
• severe disease stage defined by NPS ≥5 or SNOT-22 ≥50;
• inadequate symptom control with INCS therapy;
• failure or intolerance of previous medical treatments (at least 2 cycles of systemic corticosteroid in the last year), and/or failure of previous surgical treatment through nasal endoscopic surgery (ESS), with postoperative complications or no clinical benefit

Exclusion Criteria

• pregnant women;
• immunosuppressive therapy;
• patients undergoing radio-chemotherapy treatments for cancer in the 12 months before the starting of therapy;
• 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

Principal Investigators

Eugenio De Corso, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Locations

AUSL Bologna

Bologna, , Italy

Azienda Ospedaliero-Universitaria Policlinico S. Marco

Catania, , Italy

AUSL Latina

Latina, , Italy

ASST Santi Paolo e Carlo - Presidio San Paolo

Milan, , Italy

IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, , Italy

IRCCS San Raffaele

Milan, , Italy

Azienda Ospedaliero-Universitaria di Modena

Modena, , Italy

A.O.R.N. Ospedali dei Colli

Napoli, , Italy

Azienda Ospedaliera Policlinico Federico II

Napoli, , Italy

Ospedale maggiore di Novara

Novara, , Italy

Ospedale S.Luigi Gonzaga, Università di Torino

Orbassano, , Italy

Azienda Ospedaliero-Universitaria di Padova

Padua, , Italy

Policlinico San Matteo-Università di Pavia

Pavia, , Italy

Azienda Ospedaliero-Universitaria Pisana

Pisa, , Italy

Azienda USL - IRCCS di Reggio Emilia

Reggio Emilia, , Italy

ASL Roma 5

Roma, , Italy

Fondazione Policlinico Universitario A.Gemelli IRCCS

Roma, , Italy

Università La Sapienza

Roma, , Italy

Azienda Ospedaliero-Universitaria di Sassari

Sassari, , Italy

Countries

Italy

Other Identifiers

0034704/21

Identifier Type: -

Identifier Source: org_study_id