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)

Status Active, not recruiting

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

Related Conditions & MeSH terms

• Chronic Rhinosinusitis With Nasal Polyps
• Nasal Polyps

• NCT number: NCT05529784
• Study type: Observational
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Status: Active, not recruiting
• Start date: October 6, 2021
• Completion date: October 1, 2023