Clinical trial NCT06393946: Study in Adults With Severe Chronic Rhinosinusitis With Nasal Polyposis Treated With Dupilumab in France
Official title: Observational Study in Adults With Severe Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP) Treated With Dupilumab in France
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Rhinosinusitis With Nasal Polyposis
Keywords: Real World Evidence (RWE)
ENT disease
CRSwNP
Nasal Polyp Syndrome
Dupixent
Surgery
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2024-05-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with asthma initiating Dupilumab for their Severe chronic rhinosinusitis with nasal polyposis (CRSwNP) according to the prescribing information in France.

Brief summary: 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


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.

Primary outcomes:
measure: Patient characteristics: Age
timeFrame: At baseline (Day 1)
measure: Patient characteristics: Sex
timeFrame: At baseline (Day 1)
measure: Patient characteristics: Weight
timeFrame: At baseline (Day 1)
measure: Patient characteristics: Height
timeFrame: At baseline (Day 1)
measure: Patient characteristics: Type 2 comorbidities
timeFrame: At baseline (Day 1)
measure: Patient characteristics: Medical history
timeFrame: At baseline (Day 1)
measure: Patient characteristics: Lifestyle habits
timeFrame: At baseline (Day 1)
measure: Disease characteristics: CRSwNP duration
timeFrame: At baseline (Day 1)
measure: Disease characteristics: Age at diagnosis of CRSwNP
timeFrame: At baseline (Day 1)
measure: Disease characteristics: Blood Eosinophils
timeFrame: At baseline (Day 1)
measure: Disease characteristics: Total serum IgE
timeFrame: At baseline (Day 1)
measure: Disease characteristics: Anatomopathology
timeFrame: At baseline (Day 1)
measure: Disease characteristics: Nasal polyps score (NPS) at baseline
timeFrame: At baseline (Day 1)
measure: Disease characteristics: Nasal congestion score (NCS) at baseline
timeFrame: At baseline (Day 1)
measure: Disease characteristics: Rhinorrhea score (anterior/posterior) at baseline
timeFrame: At baseline (Day 1)
measure: Disease characteristics: VAS for CRSwNP symptoms at baseline
timeFrame: At baseline (Day 1)
measure: Disease characteristics: smell test score Visual Analog Scale (VAS) at baseline
timeFrame: At baseline (Day 1)
measure: Concomitant and prior medications for CRSwNP or other disease: Number of patients with at least one prior or concomitant SCS
timeFrame: From baseline up to 24 months.
measure: Concomitant and prior medications for CRSwNP or other disease:Type of prior Systemic Corticosteroids (SCS) per patient
timeFrame: From baseline up to 24 months.
measure: Concomitant and prior medications for CRSwNP or other disease: Cumulative dose of SCS
timeFrame: From baseline up to 24 months.
measure: Concomitant and prior medications for CRSwNP or other disease: Total number of SCS bursts per patient
timeFrame: From baseline up to 24 months.
measure: Concomitant and prior medications for CRSwNP or other disease: Recovery of sense of smell after SCS
timeFrame: From baseline up to 24 months.
measure: Concomitant and prior medications for CRSwNP or other disease:Time since the most recent SCS burst before initiation of Dupixent®
timeFrame: From baseline up to 24 months.
measure: Concomitant and prior medications for CRSwNP or other disease: Number of prior or respiratory concomitant biotherapies per patient
timeFrame: From baseline up to 24 months.
measure: Concomitant and prior medications for CRSwNP or other diseases: Indication
timeFrame: From baseline up to 24 months.
measure: Concomitant and prior medications for CRSwNP or other diseases: Reason for stop
timeFrame: From baseline up to 24 months.
measure: Dupilumab (Dupixent®) modalities: Dosage
timeFrame: From baseline up to 24 months.
measure: Dupilumab (Dupixent®) modalities: Injection modalities
timeFrame: From baseline up to 24 months.
measure: Dupilumab (Dupixent®) modalities: Treatment duration
timeFrame: From baseline up to 24 months.
measure: Dupilumab (Dupixent®) modalities: Compliance with treatment
timeFrame: From baseline up to 24 months.
Secondary outcomes:
measure: Change from baseline of Nasal polyps score (NPS)
timeFrame: From baseline up to 24 months
measure: Change from baseline of Nasal congestion score (NCS)
timeFrame: From baseline up to 24 months
measure: Change from baseline of Smell test scores UPSIT
timeFrame: From baseline up to 24 months
measure: Change from baseline of smell test score Visual Analog Scale (VAS)
timeFrame: From baseline up to 24 months
measure: Change from baseline of Quality of life questionnaire for patients with sino nasal symptoms (SNOT22)
timeFrame: From baseline up to 24 months
measure: Change from baseline of VAS for CRSwNP symptoms
timeFrame: From baseline up to 24 months
measure: Change from baseline of Rhinorrhea score (anterior/posterior)
timeFrame: From baseline up to 24 months
measure: Change from baseline of number of SCS bursts/ surgery for CRSwNP
timeFrame: From baseline up to 24 months
measure: Health care resource utilization (HCRU) for CRSwNP
timeFrame: From baseline up to 24 months.
measure: Sense of smell impairment other than related to CRSwNP (Covid19)
timeFrame: From baseline up to 24 months.
measure: Number of Adverse Events (AE) / Serious Adverse Events (SAE)
timeFrame: From date of signed ICF or from date of Day 1 whichever comes first, up to 24 months
measure: Site characteristics
timeFrame: At baseline (Day 1)
Other outcomes:
Locations:
city: Nantes
country: France
facility: Investigational Site Number: 250.0001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: