BIOlogics in Severe Nasal POlyposis SurvEy

Chronic Rhinosinusitis With Nasal Polyps Clinical Trial

— BIOPOSE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05228041
• Other study ID #: DRI_2021/0030
• Status: Recruiting
• Start date: February 10, 2022
• Est. completion date: July 2027

Study information

• Verified date: February 2022
• Source: University Hospital, Lille
• Contact: Goeffrey Mortuaire, MD
• Phone: 0320445962
• Email: geoffrey.mortuaire[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2027
• Est. primary completion date: July 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Rhinosinusitis With Nasal Polyps
• Nasal Polyps
• Polyps
• Sinusitis

Intervention

Drug:
• Biologic treatments available in CRSwNP (dupilumab, mepolizumab and benralizumab according to their marketing approval)
Drug prescription according to their marketing approval (subcutaneously, every month or every two weeks)

Locations

Country	Name	City	State
France	Hop Claude Huriez Chu Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Visual analogical scale (VAS) for rhinorrhea	from 0 to 10, 10 = worst outcome	Day 0, Month 3, Month 6, Month 12 and Month 18
Secondary	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
Secondary	Number of systemic corticosteroid treatment courses between each visit		Day 0, Month 3, Month 6, Month 12 and Month 18
Secondary	Delay to first surgical procedure		Day 0, Month 3, Month 6, Month 12 and Month 18
Secondary	Blood eosinophil count	number of cells per mm3	Day 0, Month 3, Month 6, Month 12 and Month 18
Secondary	Blood total IgE concentrations	concentration expressed by KUI/L	Day 0, Month 3, Month 6, Month 12 and Month 18