BIOlogics in Severe Nasal POlyposis SurvEy.: a French Registry

Sponsor
University Hospital, Lille
Study ID
NCT06501807
Status
Recruiting
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Conditions

  • Nasal Polyps
  • Rhinosinusitis Chronic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

With a prevalence of 2-4% in western countries, Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) is of major concern regarding its substantial impact on the social and physical quality of life. So far, endoscopic sinus surgery remains the treatment of choice when the first line of medical treatment with corticosteroid has failed. During the last 15 years, several studies have shown that CRSwNP is associated with a T helper 2 (T2) immune response leading to B cell release of IgE, mucosal recruitment of eosinophils from bone marrow via Interleukin (IL)-5, IL-4 and IL-13 mediated chemoattractant production. New biologic agents capable of blocking T2 cytokines have been developed in the field of eosinophil-associated diseases, shifting the paradigm of treatment for patients with CRSwNP. In the near future, endotype profiling with accurate biomarkers will be mandatory to tailor the treatment of nasal polyposis with specific biologic therapies. Herein the investigators propose a prospective study monitoring medical records of CRSwNP patients who undergo biologic treatments. The objectives are to assess treatment efficacy on quality of life, to report clinical and biological criteria for prescription and to measure tolerance and compliance.Patient-reported outcomes will be addressed according to their initial clinical profile (allergy, asthma, NSAID, gastroesophageal reflux disease, obstructive apnea, otologic disorder, smoke habit).

Key Dates

Start date
Jul 11, 2024
Status verified
May 2026
Primary completion
Sep 2, 2034
Completion
Jan 2, 2035

Study Design

Enrollment
900 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Biologic treatments available
    Biologic treatments available in CRSwNP (dupilumab, mepolizumab and benralizumab according to their marketing approval).

Primary Outcome Measure

Comparison of quality of life over 5 years according to the asthmatic status of the patients [ Time Frame: 5-year follow-up ]

Central Contacts

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