Study in Adults With Severe Chronic Rhinosinusitis With Nasal Polyposis Treated With Dupilumab in France

NCT06393946 | Active Not Recruiting

• 2 other identifiers: OBS17269U1111-1264-3068
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Rhinosinusitis With Nasal Polyposis

Keywords

Real World Evidence (RWE); ENT disease; CRSwNP; Nasal Polyp Syndrome; Dupixent; Surgery

Outcome Measures

Primary Outcomes (30)

• 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

  The following patient characteristics will be described: Documented comorbidities associated with type 2 inflammation (asthma + severity, atopic dermatitis, Aspirin Exacerbated Disease (AERD), chronic allergic rhinitis)

  At baseline (Day 1)

• Patient characteristics: Medical history

  Including CRSwNP history and CRSwNP family history.

  At baseline (Day 1)

• Patient characteristics: Lifestyle habits

  Including smoking 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

  The results of the last test carried out before Dupixent® initiation will be used as baseline, as per standard of care, if available.

  At baseline (Day 1)

• Disease characteristics: Total serum IgE

  The results of the last test carried out before Dupixent® initiation will be used as baseline, as per standard of care, if available.

  At baseline (Day 1)

• Disease characteristics: Anatomopathology

  The results of the last exam carried out before Dupixent® initiation will be used as baseline, as per standard of care, if available.

  At baseline (Day 1)

• Disease characteristics: Nasal polyps score (NPS) at baseline

  The nasal polyps endoscopic score (NPS) assesses length and distribution of polyps, with a score from 0 to 4 for each nostril, maximum bilateral score of 8 points. Meaning lower (0=no polyp) and higher (4=large polyps).

  At baseline (Day 1)

• Disease characteristics: Nasal congestion score (NCS) at baseline

  The Nasal congestion score (NCS) was assessed on a scale of 0 to 3, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms, with higher scores indicating more severity.

  At baseline (Day 1)

• Disease characteristics: Rhinorrhea score (anterior/posterior) at baseline

  The rhinorrhea scores are scored from 0 ('No symptoms') to 3 ('Severe symptoms'). Where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms, with higher scores indicating more severity.

  At baseline (Day 1)

• Disease characteristics: VAS for CRSwNP symptoms at baseline

  The Visual Analog Scale for CRSwNP assesses symptoms, ranging from 0 to 10: * mild if VAS between 0 and 3 * moderate if VAS between \> 3 and 7 * severe if VAS between \> 7 and 10.

  At baseline (Day 1)

• Disease characteristics: smell test score Visual Analog Scale (VAS) at baseline

  Participants value their olfactory function by using the Visual Analogue Scale (VAS), the range of the VAS was from 0 (not troublesome) to 10 (worse thinkable troublesome), where higher score indicated worse thinkable troublesome.

  At baseline (Day 1)

• Concomitant and prior medications for CRSwNP or other disease: Number of patients with at least one prior or concomitant SCS

  Number of patients with at least one prior or concomitant Systemic Corticosteroids (SCS)

  From baseline up to 24 months.

• Concomitant and prior medications for CRSwNP or other disease:Type of prior Systemic Corticosteroids (SCS) per patient

  Prior (resp. concomitant) SCS taken (Prednisone/Prednisolone/Betamethasone/Methylprednisolone)

  From baseline up to 24 months.

• Concomitant and prior medications for CRSwNP or other disease: Cumulative dose of SCS

  Cumulative dose over the past year

  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

  Recovery of sense of smell after SCS will be described.

  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

  Number of prior, resp. concomitant biotherapies per patient

  From baseline up to 24 months.

• Concomitant and prior medications for CRSwNP or other diseases: Indication

  Indication (CRSwNP/Asthma/Atopic dermatitis/Prurigo nodularis/Eosinophilic esophagitis)

  From baseline up to 24 months.

• Concomitant and prior medications for CRSwNP or other diseases: Reason for stop

  Reason for stop will be describe.

  From baseline up to 24 months.

• Dupilumab (Dupixent®) modalities: Dosage

  From baseline up to 24 months.

• Dupilumab (Dupixent®) modalities: Injection modalities

  Injection modalities (Nurse/Caregiver/Self-injection)

  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.

Secondary Outcomes (12)

• Change from baseline of Nasal polyps score (NPS)

  From baseline up to 24 months

• Change from baseline of Nasal congestion score (NCS)

  From baseline up to 24 months

• Change from baseline of Smell test scores UPSIT

  From baseline up to 24 months

• Change from baseline of smell test score Visual Analog Scale (VAS)

  From baseline up to 24 months

• Change from baseline of Quality of life questionnaire for patients with sino nasal symptoms (SNOT22)

  From baseline up to 24 months

Study Arms (1)

Dupilumab

The information will be collected during consultation as part of the patient's usual follow-up.

Drug: Dupilumab

Interventions

Dupilumab DRUG

This study will not administer any treatment, only observe the treatment as prescribed in real world-clinical practice.

Dupilumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patient aged \>= 18 years old at the time of the initiation of the treatment with dupilumab (Dupixent®).
• Informed consent and willingness to participate.

You may not qualify if:

• Conditions or legal situations resulting in impossibility to consent or impacting the interpretation of the results.

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

Investigational Site Number: 250.0001

Nantes, 44093, France

Location

MeSH Terms

Conditions

Otorhinolaryngologic Diseases

Interventions

dupilumab

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: May 1, 2024
• Study Start: October 20, 2023
• Primary Completion: April 28, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)