Study in Adults With Severe Chronic Rhinosinusitis With Nasal Polyposis Treated With Dupilumab in France
- Conditions
- Chronic Rhinosinusitis With Nasal Polyposis
- Interventions
- Registration Number
- NCT06393946
- Lead Sponsor
- Sanofi
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 150
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Dupilumab Dupilumab The information will be collected during consultation as part of the patient's usual follow-up.
- Primary Outcome Measures
Name Time Method Patient characteristics: Height At baseline (Day 1) Patient characteristics: Weight At baseline (Day 1) Disease characteristics: Nasal polyps score (NPS) at baseline At baseline (Day 1) 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).
Concomitant and prior medications for CRSwNP or other disease:Type of prior Systemic Corticosteroids (SCS) per patient From baseline up to 24 months. Prior (resp. concomitant) SCS taken (Prednisone/Prednisolone/Betamethasone/Methylprednisolone)
Disease characteristics: CRSwNP duration At baseline (Day 1) Disease characteristics: Rhinorrhea score (anterior/posterior) at baseline At baseline (Day 1) 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.
Disease characteristics: smell test score Visual Analog Scale (VAS) at baseline At baseline (Day 1) 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.
Patient characteristics: Sex At baseline (Day 1) Dupilumab (Dupixent®) modalities: Treatment duration From baseline up to 24 months. Patient characteristics: Age At baseline (Day 1) Patient characteristics: Type 2 comorbidities At baseline (Day 1) 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)
Patient characteristics: Medical history At baseline (Day 1) Including CRSwNP history and CRSwNP family history.
Disease characteristics: Blood Eosinophils At baseline (Day 1) The results of the last test carried out before Dupixent® initiation will be used as baseline, as per standard of care, if available.
Disease characteristics: Nasal congestion score (NCS) at baseline At baseline (Day 1) 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.
Disease characteristics: VAS for CRSwNP symptoms at baseline At baseline (Day 1) 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.Concomitant and prior medications for CRSwNP or other disease: Cumulative dose of SCS From baseline up to 24 months. Cumulative dose over the past year
Concomitant and prior medications for CRSwNP or other disease: Recovery of sense of smell after SCS From baseline up to 24 months. Recovery of sense of smell after SCS will be described.
Patient characteristics: Lifestyle habits At baseline (Day 1) Including smoking habits
Disease characteristics: Age at diagnosis of CRSwNP At baseline (Day 1) Dupilumab (Dupixent®) modalities: Dosage 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. Disease characteristics: Total serum IgE At baseline (Day 1) The results of the last test carried out before Dupixent® initiation will be used as baseline, as per standard of care, if available.
Disease characteristics: Anatomopathology At baseline (Day 1) The results of the last exam carried out before Dupixent® initiation will be used as baseline, as per standard of care, if available.
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: Number of prior or respiratory concomitant biotherapies per patient From baseline up to 24 months. Number of prior, resp. concomitant biotherapies per patient
Concomitant and prior medications for CRSwNP or other diseases: Reason for stop From baseline up to 24 months. Reason for stop will be describe.
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. Number of patients with at least one prior or concomitant Systemic Corticosteroids (SCS)
Concomitant and prior medications for CRSwNP or other diseases: Indication From baseline up to 24 months. Indication (CRSwNP/Asthma/Atopic dermatitis/Prurigo nodularis/Eosinophilic esophagitis)
Dupilumab (Dupixent®) modalities: Injection modalities From baseline up to 24 months. Injection modalities (Nurse/Caregiver/Self-injection)
Dupilumab (Dupixent®) modalities: Compliance with treatment From baseline up to 24 months.
- Secondary Outcome Measures
Name Time Method Change from baseline of Nasal polyps score (NPS) From baseline up to 24 months 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).
Change from baseline of number of SCS bursts/ surgery for CRSwNP From baseline up to 24 months Rescue therapy: The number of SCS bursts/ surgery for CRSwNP will be reported.
Site characteristics At baseline (Day 1) Site characteristics (University/general Hospital/private clinic) will be described.
Change from baseline of VAS for CRSwNP symptoms From baseline up to 24 months 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.Sense of smell impairment other than related to CRSwNP (Covid19) From baseline up to 24 months. Collection of: Sense of smell impairment other than related to CRSwNP (Covid19) will be reported. If present, an Adverse Event (AE) will be recorded.
Change from baseline of Nasal congestion score (NCS) From baseline up to 24 months 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.
Change from baseline of smell test score Visual Analog Scale (VAS) From baseline up to 24 months 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.
Change from baseline of Quality of life questionnaire for patients with sino nasal symptoms (SNOT22) From baseline up to 24 months SNOT-22 is a patient-reported outcome (PRO) questionnaire. Score ranges from 0 to 110 with higher score indicating greater rhinosinusitis related health burden.
Change from baseline of Smell test scores UPSIT From baseline up to 24 months 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.
Health care resource utilization (HCRU) for CRSwNP From baseline up to 24 months. Health care resource utilization may include hospitalizations (including length of stay), outpatient visits, emergency room visits, specific transfusion visits.
Change from baseline of Rhinorrhea score (anterior/posterior) From baseline up to 24 months 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.
Number of Adverse Events (AE) / Serious Adverse Events (SAE) From date of signed ICF or from date of Day 1 whichever comes first, up to 24 months The number of events and the percentage of patients who had at least one event will be described.
Trial Locations
- Locations (1)
Investigational Site Number: 250.0001
🇫🇷Nantes, France