BIOlogics in Severe Nasal POlyposis SurvEy (BIOPOSE)

Real Life Assessment of Biologics Efficacy in Severe Chronic Rhinosinusitis With Nasal Polyps

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Rhinosinusitis With Nasal Polyps
• Intervention / Treatment: Drug: Biologic treatments available in CRSwNP (dupilumab, mepolizumab and benralizumab according to their marketing approval)

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Goeffrey Mortuaire, MD; Phone Number: +33 0320445962; Email: geoffrey.mortuaire@chru-lille.fr

Study Locations

• France
  • Lille, France, 59037
    • Recruiting
    • Hop Claude Huriez Chu Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	from 0 to 110 , 110 = worst outcome	Day0, Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SNOT 22 (Sinonasal Outcome Test-22) scores	from 0 to 110 , 110 = worst outcome	Day 0, Month 3, Month 6, Month 12 and Month 18
Visual analogical scale (VAS) for nasal obstruction	from 0 to 10, 10 = worst outcome	Day 0, Month 3, Month 6, Month 12 and Month 18
Visual analogical scale (VAS) for smell lost	from 0 to 10, 10 = worst outcome	Day 0, Month 3, Month 6, Month 12 and Month 18
Visual analogical scale (VAS) for rhinorrhea	from 0 to 10, 10 = worst outcome	Day 0, Month 3, Month 6, Month 12 and Month 18
Visual analogical scale (VAS) for craniofacial pain	from 0 to 10, 10 = worst outcome	Day 0, Month 3, Month 6, Month 12 and Month 18
Number of systemic corticosteroid treatment courses between each visit		Day 0, Month 3, Month 6, Month 12 and Month 18
Delay to first surgical procedure		Day 0, Month 3, Month 6, Month 12 and Month 18
Blood eosinophil count	number of cells per mm3	Day 0, Month 3, Month 6, Month 12 and Month 18
Blood total IgE concentrations	concentration expressed by KUI/L	Day 0, Month 3, Month 6, Month 12 and Month 18

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Geoffrey Mortuaire, MD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2022
• Primary Completion (Anticipated): July 1, 2027
• Study Completion (Anticipated): July 1, 2027

Study Registration Dates

• First Submitted: December 17, 2021
• First Submitted That Met QC Criteria: February 7, 2022
• First Posted (Actual): February 8, 2022

Study Record Updates

• Last Update Posted (Actual): April 12, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Biologic; chronic rhinosinusitis; eosinophil; nasal polyp; endotype
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Pathological Conditions, Anatomical; Nose Diseases; Nasal Polyps; Polyps; Anti-Asthmatic Agents; Respiratory System Agents; Benralizumab
• Other Study ID Numbers: DRI_2021/0030

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No