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

Chronic Rhinosinusitis With Nasal Polyps Clinical Trial

— DUPIREAL  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05529784
• Other study ID #: 0034704/21
• Status: Active, not recruiting
• Start date: October 6, 2021
• Est. completion date: October 1, 2023

Study information

• Verified date: February 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Rhinosinusitis With Nasal Polyps
• Nasal Polyps

Intervention

Drug:
• Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]
Dupilumab 300mg in pre-filled injector Q2W

Locations

Country	Name	City	State
Italy	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	Milano
Italy	IRCCS San Raffaele	Milano
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	Padova
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

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nasal Polyp Score (NPS)	Polyps volume. Range 0-4 for each nostril. Higher score describes a worse condition	12 months
Secondary	Nasal Polyp Score (NPS)	Polyps volume. Range 0-4 for each nostril. Higher score describes a worse condition	24 months
Secondary	Nasal congestion score (NCS)	Nasal congestion. Range 0-3. Higher score describes a worse condition	12 months and 24 months
Secondary	Sinonasal outcome test (SNOT-22)	Symptoms. Range 0-110. Higher score describes a worse condition	12 months and 24 months
Secondary	Sniffin' sticks identification test	Olfaction. Range 0-16. Higher score describes a better condition	12 months and 24 months
Secondary	Visual Analog Scale (VAS) for nasal congestion	Nasal congestion. Range 0-10. Higher score describes a more severe symptom	12 months and 24 months
Secondary	Visual Analog Scale (VAS) for olfaction loss	Olfaction loss. Range 0-10. Higher score describes a more severe symptom	12 months and 24 months
Secondary	Visual Analog Scale (VAS) for craniofacial pain	Craniofacial pain. Range 0-10. Higher score describes a more severe symptom	12 months and 24 months
Secondary	Visual Analog Scale (VAS) for sleeping disorders	Sleeping disorders. Range 0-10. Higher score describes a more severe symptom	12 months and 24 months
Secondary	Visual Analog Scale (VAS) for rhinorrhea	Rhinorrhea. Range 0-10. Higher score describes a more severe symptom	12 months and 24 months
Secondary	Visual Analog Scale (VAS) for quality of life	Quality of life. Range 0-10. Higher score describes a worse quality of life	12 months and 24 months
Secondary	Need for surgery	Number of surgeries performed during therapy	12 months and 24 months
Secondary	Intranasal corticosteroid adherence	Number of days of suspension of intranasal corticosteroids	12 months and 24 months
Secondary	Need for rescue oral corticosteroids	Number of short cycles of oral corticosteroids during therapy	12 months and 24 months