Clinical trial
Observational Study in Adults With Severe Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP) Treated With Dupilumab in France
Name
OBS17269
Description
This is a multicentre, non-interventional, single arm study that aims to describe the treatment patterns in France: patients' characteristics, disease characteristics, prior treatments for Severe chronic rhinosinusitis with nasal polyposis and treatment prescription modalities. As well as to assess the clinical outcome after initiation of dupilumab (Dupixent®) and safety of the product during the two years of treatment
Trial arms
Trial start
2023-10-20
Estimated PCD
2026-04-28
Trial end
2026-09-18
Status
Recruiting
Treatment
Dupilumab
This study will not administer any treatment, only observe the treatment as prescribed in real world-clinical practice.
Arms:
Dupilumab
Size
150
Primary endpoint
Patient characteristics: Age
At baseline (Day 1)
Patient characteristics: Sex
At baseline (Day 1)
Patient characteristics: Weight
At baseline (Day 1)
Patient characteristics: Height
At baseline (Day 1)
Patient characteristics: Type 2 comorbidities
At baseline (Day 1)
Patient characteristics: Medical history
At baseline (Day 1)
Patient characteristics: Lifestyle habits
At baseline (Day 1)
Disease characteristics: CRSwNP duration
At baseline (Day 1)
Disease characteristics: Age at diagnosis of CRSwNP
At baseline (Day 1)
Disease characteristics: Blood Eosinophils
At baseline (Day 1)
Disease characteristics: Total serum IgE
At baseline (Day 1)
Disease characteristics: Anatomopathology
At baseline (Day 1)
Disease characteristics: Nasal polyps score (NPS) at baseline
At baseline (Day 1)
Disease characteristics: Nasal congestion score (NCS) at baseline
At baseline (Day 1)
Disease characteristics: Rhinorrhea score (anterior/posterior) at baseline
At baseline (Day 1)
Disease characteristics: VAS for CRSwNP symptoms at baseline
At baseline (Day 1)
Disease characteristics: smell test score Visual Analog Scale (VAS) at baseline
At baseline (Day 1)
Concomitant and prior medications for CRSwNP or other disease: Number of patients with at least one prior or concomitant SCS
From baseline up to 24 months.
Concomitant and prior medications for CRSwNP or other disease:Type of prior Systemic Corticosteroids (SCS) per patient
From baseline up to 24 months.
Concomitant and prior medications for CRSwNP or other disease: Cumulative dose of SCS
From baseline up to 24 months.
Concomitant and prior medications for CRSwNP or other disease: Total number of SCS bursts per patient
From baseline up to 24 months.
Concomitant and prior medications for CRSwNP or other disease: Recovery of sense of smell after SCS
From baseline up to 24 months.
Concomitant and prior medications for CRSwNP or other disease:Time since the most recent SCS burst before initiation of Dupixent®
From baseline up to 24 months.
Concomitant and prior medications for CRSwNP or other disease: Number of prior or respiratory concomitant biotherapies per patient
From baseline up to 24 months.
Concomitant and prior medications for CRSwNP or other diseases: Indication
From baseline up to 24 months.
Concomitant and prior medications for CRSwNP or other diseases: Reason for stop
From baseline up to 24 months.
Dupilumab (Dupixent®) modalities: Dosage
From baseline up to 24 months.
Dupilumab (Dupixent®) modalities: Injection modalities
From baseline up to 24 months.
Dupilumab (Dupixent®) modalities: Treatment duration
From baseline up to 24 months.
Dupilumab (Dupixent®) modalities: Compliance with treatment
From baseline up to 24 months.
Eligibility criteria
Inclusion Criteria:
* Patient aged \>= 18 years old at the time of the initiation of the treatment with dupilumab (Dupixent®).
* Decision to initiate Dupixent® prior to inclusion in the study, initiation of Dupixent® for severe Chronic rhinosinusitis with nasal polyposis (CRSwNP) maximum 3 months before inclusion.
* Informed consent and willingness to participate.
Exclusion Criteria:
* Conditions or legal situations resulting in impossibility to consent or impacting the interpretation of the results.
* Patient participating in an interventional clinical trial with experimental product at inclusion.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}
Updated at
2024-05-01
1 organization
1 product
1 indication
Organization
SanofiProduct
Dupilumab