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

Chronic Rhinosinusitis With Nasal Polyps Clinical Trial

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

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05529784
Study type Observational
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact
Status Active, not recruiting
Phase
Start date October 6, 2021
Completion date October 1, 2023
View Details
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