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

Sanofi

Status: Active, not recruiting

Conditions: Chronic Rhinosinusitis With Nasal Polyposis

Treatments: Drug: Dupilumab

Study type: Observational

Funder types: Industry

Identifiers

NCT06393946

OBS17269

U1111-1264-3068 (Registry Identifier)

Details and patient eligibility

About

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

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

150 participants in 1 patient group

Dupilumab

Description:

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

Treatment:

Drug: Dupilumab