BIOlogics in Severe Nasal POlyposis SurvEy.: a French Registry

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Lille

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients of over 18-year old requiring a biologic treatment for CRswNP in accordance with its marketing approval.

The patients already treated according to this criteria since August 2021 will be followed and their previous clinical and biological data retrospectively collected

Disqualifiers

Oral corticotherapy in the previous month;

Biologic treatment with anti-IgE (omalizumab), anti-IL-5/IL-5R (mepolizumab, benralizumab) or anti-IL-4/IL-13R (dupilumab) or any other biotherapy for inflammatory diseases in the previous 6 months of initiation of treatment apart from ongoing biotherapies for severe asthma or CRSwNP;

Hypersensitivity to humanized antibodies ;

Documented SARS-Cov2 infection in the last 3 months with persistent olfactory disorders related to COVID;

Trial design

Design model

Single group

Treatments tested in this trial

  • Biologic treatments available in Chronic Rhinosinusitis with Nasal Polyps (dupilumab, mepolizumab and benralizumab according to their marketing approval).

    Drug

    Drug prescription according to their marketing approval (subcutaneously, every month or every two weeks).

Treatment groups

900 Participants
are divided into 1 treatment group
Group A: Biologic treatments availableOther 1 intervention

Trial outcomes

Primary outcomes

1

Comparison of quality of life over 5 years according to the asthmatic status of the patients

Assessment of disease control with the Sino-nasal outcome test-22. from 0 to 110, 110=worst outcome

Time frame
5-year follow-up

Secondary outcomes

1

Quality of life progression in patients with Chronic Rhinosinusitis with Nasal Polyps

Assessment of disease control with the Sino-nasal outcome test-22. from 0 to 110, 110=worst outcome

Time frame
Evaluation after 6 months of treatment with biologics
2

Patient reported symptoms measurement

Number of oral corticosteroid treatment courses between each visit (in grammes)

Time frame
Month 0, Month 3, Month 6, and every 6 months until 5 years
3

Time to first surgical procedure since the beginning of biologic treatment

Date and type of sinus surgery between each visit

Time frame
MMonth 0, Month 3, Month 6, and every 6 months until 5 years
4

Blood eosinophil count and total IgE blood concentrations evolution during the course of the 5-year follow-up

Number off cells per mm3

Time frame
Month 0, Month 3, Month 6, and every 6 months until 5 years

Other outcomes

Sponsors and contacts

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