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

Observational Study in Adults With Severe Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP) Treated With Dupilumab in France

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

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Rhinosinusitis With Nasal Polyposis
• Intervention / Treatment: Drug: Dupilumab

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44093
    • Investigational Site Number: 250.0001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Dupilumab; The information will be collected during consultation as part of the patient's usual follow-up.	Drug: Dupilumab; This study will not administer any treatment, only observe the treatment as prescribed in real world-clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline of Nasal polyps score (NPS)	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).	From baseline up to 24 months
Change from baseline of Nasal congestion score (NCS)	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.	From baseline up to 24 months
Change from baseline of Smell test scores UPSIT	The UPSIT (UPSIT 40-odorant test) quantifies human olfactory function. Being the scores: ≤ 18 (anosmia) / [19-25] (severe hyposmia) / [26-30] (moderate hyposmia) / [31-34] (mild hyposmia) / [35-40] (normosmia)). A higher score indicating a better function.	From baseline up to 24 months
Change from baseline of smell test score Visual Analog Scale (VAS)	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.	From baseline up to 24 months
Change from baseline of Quality of life questionnaire for patients with sino nasal symptoms (SNOT22)	SNOT-22 is a patient-reported outcome (PRO) questionnaire. Score ranges from 0 to 110 with higher score indicating greater rhinosinusitis related health burden.	From baseline up to 24 months
Change from baseline of VAS for CRSwNP symptoms	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.	From baseline up to 24 months
Change from baseline of Rhinorrhea score (anterior/posterior)	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.	From baseline up to 24 months
Change from baseline of number of SCS bursts/ surgery for CRSwNP	Rescue therapy: The number of SCS bursts/ surgery for CRSwNP will be reported.	From baseline up to 24 months
Health care resource utilization (HCRU) for CRSwNP	Health care resource utilization may include hospitalizations (including length of stay), outpatient visits, emergency room visits, specific transfusion visits.	From baseline up to 24 months.
Sense of smell impairment other than related to CRSwNP (Covid19)	Collection of: Sense of smell impairment other than related to CRSwNP (Covid19) will be reported. If present, an Adverse Event (AE) will be recorded.	From baseline up to 24 months.
Number of Adverse Events (AE) / Serious Adverse Events (SAE)	The number of events and the percentage of patients who had at least one event will be described.	From date of signed ICF or from date of Day 1 whichever comes first, up to 24 months
Site characteristics	Site characteristics (University/general Hospital/private clinic) will be described.	At baseline (Day 1)

Collaborators and Investigators

• Sponsor: Sanofi
• Collaborators: Regeneron Pharmaceuticals
• Investigators: Study Director: Clinical Sciences & Operations, Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: April 10, 2024
• First Submitted That Met QC Criteria: April 26, 2024
• First Posted (Actual): May 1, 2024

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Surgery; CRSwNP; Dupixent; Real World Evidence (RWE); ENT disease; Nasal Polyp Syndrome
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Intestinal Neoplasms; Rectal Diseases; Paranasal Sinus Diseases; Nose Diseases; Polyps; Rhinitis; Otorhinolaryngologic Diseases; dupilumab
• Other Study ID Numbers: OBS17269; U1111-1264-3068 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org