MedTrace Logo

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

NCT05529784 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2023-02-21

No results posted yet for this study

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

Interventions

DRUG

Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]

Dupilumab 300mg in pre-filled injector Q2W

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Eugenio De Corso, MD, PhD · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-06
Primary Completion
2022-10-01
Completion
2023-10-01
FDA Drug
Yes

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05529784 on ClinicalTrials.gov