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NCT Number: NCT06393946

Study in Adults With Severe Chronic Rhinosinusitis With Nasal Polyposis 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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Chronic Rhinosinusitis With Nasal Polyposis Otorhinolaryngologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Investigational Site Number: 250.0001

Nantes, 44093, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dupilumab

Drug

This study will not administer any treatment, only observe the treatment as prescribed in real world-clinical practice.

Primary outcomes

  1. Patient characteristics: Age

    Time frame: At baseline (Day 1)

  2. Patient characteristics: Sex

    Time frame: At baseline (Day 1)

  3. Patient characteristics: Weight

    Time frame: At baseline (Day 1)

  4. Patient characteristics: Height

    Time frame: At baseline (Day 1)

  5. Patient characteristics: Type 2 comorbidities

    Time frame: 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)

  6. Patient characteristics: Medical history

    Time frame: At baseline (Day 1)

    Including CRSwNP history and CRSwNP family history.

  7. Patient characteristics: Lifestyle habits

    Time frame: At baseline (Day 1)

    Including smoking habits

  8. Disease characteristics: CRSwNP duration

    Time frame: At baseline (Day 1)

  9. Disease characteristics: Age at diagnosis of CRSwNP

    Time frame: At baseline (Day 1)

  10. Disease characteristics: Blood Eosinophils

    Time frame: 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.

  11. Disease characteristics: Total serum IgE

    Time frame: 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.

  12. Disease characteristics: Anatomopathology

    Time frame: 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.

  13. Disease characteristics: Nasal polyps score (NPS) at baseline

    Time frame: 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).

  14. Disease characteristics: Nasal congestion score (NCS) at baseline

    Time frame: 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.

  15. Disease characteristics: Rhinorrhea score (anterior/posterior) at baseline

    Time frame: 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.

  16. Disease characteristics: VAS for CRSwNP symptoms at baseline

    Time frame: 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.

  17. Disease characteristics: smell test score Visual Analog Scale (VAS) at baseline

    Time frame: 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.

  18. Concomitant and prior medications for CRSwNP or other disease: Number of patients with at least one prior or concomitant SCS

    Time frame: From baseline up to 24 months.

    Number of patients with at least one prior or concomitant Systemic Corticosteroids (SCS)

  19. Concomitant and prior medications for CRSwNP or other disease:Type of prior Systemic Corticosteroids (SCS) per patient

    Time frame: From baseline up to 24 months.

    Prior (resp. concomitant) SCS taken (Prednisone/Prednisolone/Betamethasone/Methylprednisolone)

  20. Concomitant and prior medications for CRSwNP or other disease: Cumulative dose of SCS

    Time frame: From baseline up to 24 months.

    Cumulative dose over the past year

  21. Concomitant and prior medications for CRSwNP or other disease: Total number of SCS bursts per patient

    Time frame: From baseline up to 24 months.

  22. Concomitant and prior medications for CRSwNP or other disease: Recovery of sense of smell after SCS

    Time frame: From baseline up to 24 months.

    Recovery of sense of smell after SCS will be described.

  23. Concomitant and prior medications for CRSwNP or other disease:Time since the most recent SCS burst before initiation of Dupixent®

    Time frame: From baseline up to 24 months.

  24. Concomitant and prior medications for CRSwNP or other disease: Number of prior or respiratory concomitant biotherapies per patient

    Time frame: From baseline up to 24 months.

    Number of prior, resp. concomitant biotherapies per patient

  25. Concomitant and prior medications for CRSwNP or other diseases: Indication

    Time frame: From baseline up to 24 months.

    Indication (CRSwNP/Asthma/Atopic dermatitis/Prurigo nodularis/Eosinophilic esophagitis)

  26. Concomitant and prior medications for CRSwNP or other diseases: Reason for stop

    Time frame: From baseline up to 24 months.

    Reason for stop will be describe.

  27. Dupilumab (Dupixent®) modalities: Dosage

    Time frame: From baseline up to 24 months.

  28. Dupilumab (Dupixent®) modalities: Injection modalities

    Time frame: From baseline up to 24 months.

    Injection modalities (Nurse/Caregiver/Self-injection)

  29. Dupilumab (Dupixent®) modalities: Treatment duration

    Time frame: From baseline up to 24 months.

  30. Dupilumab (Dupixent®) modalities: Compliance with treatment

    Time frame: From baseline up to 24 months.

Secondary outcomes

  1. Change from baseline of Nasal polyps score (NPS)

    Time frame: 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).

  2. Change from baseline of Nasal congestion score (NCS)

    Time frame: 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.

  3. Change from baseline of Smell test scores UPSIT

    Time frame: 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.

  4. Change from baseline of smell test score Visual Analog Scale (VAS)

    Time frame: 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.

  5. Change from baseline of Quality of life questionnaire for patients with sino nasal symptoms (SNOT22)

    Time frame: 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.

  6. Change from baseline of VAS for CRSwNP symptoms

    Time frame: 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.

  7. Change from baseline of Rhinorrhea score (anterior/posterior)

    Time frame: 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.

  8. Change from baseline of number of SCS bursts/ surgery for CRSwNP

    Time frame: From baseline up to 24 months

    Rescue therapy: The number of SCS bursts/ surgery for CRSwNP will be reported.

  9. Health care resource utilization (HCRU) for CRSwNP

    Time frame: 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.

  10. Sense of smell impairment other than related to CRSwNP (Covid19)

    Time frame: 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.

  11. Number of Adverse Events (AE) / Serious Adverse Events (SAE)

    Time frame: 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.

  12. Site characteristics

    Time frame: At baseline (Day 1)

    Site characteristics (University/general Hospital/private clinic) will be described.

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study title

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

Acronym: OPALE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 1, 2024
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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