Clinical trial NCT05228041: BIOlogics in Severe Nasal POlyposis SurvEy
Official title: Real Life Assessment of Biologics Efficacy in Severe Chronic Rhinosinusitis With Nasal Polyps
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Rhinosinusitis With Nasal Polyps
Keywords: Biologic
nasal polyp
chronic rhinosinusitis
eosinophil
endotype
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of over 18-year old requiring a biologic treatment for CRswNP in accordance with its marketing approval

Brief summary: 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 we 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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 apart from ongoing biotherapies for severe asthma;
* Hypersensitivity to humanized antibodies ;
* Documented SARS-Cov2 infection in the last 3 months with persistent olfactory disorders related to COVID;
* Pregnant or breast-feeding women;
* Patient without social coverage

Primary outcomes:
measure: 6-month rate of patients with a SNOT-22 (Sinonasal Outcome test -22) score change over the minimal clinically important difference of 8.9 by comparison of SNOT-22 scores measured at Month 0 and Month 6
timeFrame: Day0, Month 6
Secondary outcomes:
measure: SNOT 22 (Sinonasal Outcome Test-22) scores
timeFrame: Day 0, Month 3, Month 6, Month 12 and Month 18
measure: Visual analogical scale (VAS) for nasal obstruction
timeFrame: Day 0, Month 3, Month 6, Month 12 and Month 18
measure: Visual analogical scale (VAS) for smell lost
timeFrame: Day 0, Month 3, Month 6, Month 12 and Month 18
measure: Visual analogical scale (VAS) for rhinorrhea
timeFrame: Day 0, Month 3, Month 6, Month 12 and Month 18
measure: Visual analogical scale (VAS) for craniofacial pain
timeFrame: Day 0, Month 3, Month 6, Month 12 and Month 18
measure: Number of systemic corticosteroid treatment courses between each visit
timeFrame: Day 0, Month 3, Month 6, Month 12 and Month 18
measure: Delay to first surgical procedure
timeFrame: Day 0, Month 3, Month 6, Month 12 and Month 18
measure: Blood eosinophil count
timeFrame: Day 0, Month 3, Month 6, Month 12 and Month 18
measure: Blood total IgE concentrations
timeFrame: Day 0, Month 3, Month 6, Month 12 and Month 18
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Claude Huriez Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Geoffrey Mortuaire, MD
role: PRINCIPAL_INVESTIGATOR
References: