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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1264-3068 | Registry Identifier | ICTRP |
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dupilumab | The information will be collected during consultation as part of the patient's usual follow-up. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dupilumab | Drug | This study will not administer any treatment, only observe the treatment as prescribed in real world-clinical practice. |
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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with asthma initiating Dupilumab for their Severe chronic rhinosinusitis with nasal polyposis (CRSwNP) according to the prescribing information in France.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number: 250.0001 | Nantes | 44093 | France |
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
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| ID | Term |
|---|---|
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| C582203 | dupilumab |
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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:
| 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. |
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:
| 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) |