Ignite Creation Date:
2024-05-06 @ 6:03 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05529784
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-02-21
First Post:
2022-09-02
Brief Title:
Dupilumab in the Treatment of Severe Uncontrolled CRSwNP a Multicentre Observational Real-life Study DUPIREAL
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Effectiveness of Dupilumab in the Treatment of Severe Uncontrolled CRSwNP a Multicentre Observational Real-life Study DUPIREAL
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DUPIREAL
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None