Chronic Rhinosinusitis With Nasal PolyposisOPALENCT06393946
Study in Adults With Severe Chronic Rhinosinusitis With Nasal Polyposis Treated With Dupilumab in France
An observational study of Chronic Rhinosinusitis With Nasal Polyposis, run by Sanofi at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyposis
- What is being tested?
- Dupilumab
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 20 Oct 2023to 31 Jul 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with asthma initiating Dupilumab for their Severe chronic rhinosinusitis with nasal polyposis (CRSwNP) according to the prescribing information in France.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Being tested
- Dupilumab
- Keywords
- Real World Evidence (RWE), ENT disease, CRSwNP, Nasal Polyp Syndrome, Dupixent, Surgery
- Medical subject headings
- Otorhinolaryngologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
This study will not administer any treatment, only observe the treatment as prescribed in real world-clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Dupilumab | The information will be collected during consultation as part of the patient's usual follow-up. Receives: Drug: Dupilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient characteristics: Age
Measured: At baseline (Day 1)
Patient characteristics: Sex
Measured: At baseline (Day 1)
Patient characteristics: Weight
Measured: At baseline (Day 1)
Patient characteristics: Height
Measured: 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)
Measured: At baseline (Day 1)
Patient characteristics: Medical history
Including CRSwNP history and CRSwNP family history.
Measured: At baseline (Day 1)
Patient characteristics: Lifestyle habits
Including smoking habits
Measured: At baseline (Day 1)
Disease characteristics: CRSwNP duration
Measured: At baseline (Day 1)
Disease characteristics: Age at diagnosis of CRSwNP
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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
Measured: From baseline up to 24 months.
Concomitant and prior medications for CRSwNP or other disease: Total number of SCS bursts per patient
Measured: 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.
Measured: 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®
Measured: 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
Measured: 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)
Measured: From baseline up to 24 months.
Concomitant and prior medications for CRSwNP or other diseases: Reason for stop
Reason for stop will be describe.
Measured: From baseline up to 24 months.
Dupilumab (Dupixent®) modalities: Dosage
Measured: From baseline up to 24 months.
Dupilumab (Dupixent®) modalities: Injection modalities
Injection modalities (Nurse/Caregiver/Self-injection)
Measured: From baseline up to 24 months.
Dupilumab (Dupixent®) modalities: Treatment duration
Measured: From baseline up to 24 months.
Dupilumab (Dupixent®) modalities: Compliance with treatment
Measured: From baseline up to 24 months.
Secondary outcomes (12)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start20 Oct 2023
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis With Nasal PolyposisStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393946
- Sponsor's protocol ID
- OBS17269
- Other IDs
- U1111-1264-3068
- Acronym
- OPALE
- Status last verified
- Jun 2026
- First submitted
- 10 Apr 2024
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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