NCT05529784

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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

Interventions

Type	Name	Description
DRUG	Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]	Dupilumab 300mg in pre-filled injector Q2W

Timeline

• Start date: 2021-10-06
• Primary completion: 2022-10-01
• Completion: 2023-10-01
• First posted: 2022-09-07
• Last updated: 2023-02-21

Locations

19 sites across 1 country: Italy

Regulatory

• FDA-regulated drug study