Multicenter Study

. 2024 May 15;14(5):e083112.

doi: 10.1136/bmjopen-2023-083112.

Study protocol: the biologics in severe chronic rhinosinusitis with nasal polyps survey

Valentin Favier¹, Clémentine Daveau², Florent Carsuzaa³, Maxime Fieux⁴, Clair Vandersteen⁵, Laurent Castillo⁵, Jean Francois Papon⁶, Ludovic de Gabory⁷, Nicolas Saroul⁸, Benjamin Verillaud⁹, Cécile Rumeau^{10

11}, Roger Jankowski¹⁰, Justin Michel¹², Guillaume de Bonnecaze¹³, Jean-Baptiste Lecanu¹⁴, Andre Coste^{15

16}, Emilie Béquignon¹⁷, Olivier Malard¹⁸, Geoffrey Mortuaire¹⁹

Affiliations

¹ Otorhinolaryngology, Head and Neck Surgery and Maxillofacial Surgery department, CHU Montpellier, Montpellier, France.
² Otorhinolaryngology - Head and Neck department, Hospices civils de Lyon, F-69004 Lyon, France.
³ Otorhinolaryngology and Audiophonology department, CHU Poitiers, F-86000 Poitiers, France.
⁴ Otorhinolaryngology department, Centre Hospitalier Lyon-Sud, Pierre-Benite, France.
⁵ Otorhinolaryngology department, CHU Nice - Université Côte d'Azur, Nice, France.
⁶ Otorhinolaryngology - Head and neck department - Université Paris-Saclay, Assistance Publique - Hopitaux de Paris - Bicêtre Hospital, Paris, Île-de-France, France.
⁷ Otorhinolaryngology-Head and Neck Surgery department, CHU Bordeaux, Bordeaux, France.
⁸ Otolaryngology Head and Neck Surgery department, CHU Clermont-Ferrand, Clermont-Ferrand, France.
⁹ Otorhinolaryngology department, Assistance Publique - Hopitaux de Paris - Lariboisière Hospital, Paris, Île-de-France, France.
¹⁰ Otorhinolaryngology - Head and Neck department, Université de Lorraine, CHU Nancy, F-54000 Vandoeuvre les Nancy, France.
¹¹ EA 3450 DevAH - Développement, Adaptation et Handicap. Regulations cardio-respiratoires et de la motricité, Université de Lorraine, Vandoeuvre les Nancy, France.
¹² Otorhinolaryngology- Head and Neck department, Aix-Marseille-University, Marseille, France.
¹³ Otorhinolaryngology - Head and Neck department, Larrey Hospital, Toulouse, France.
¹⁴ Otorhinolaryngology - Head and Neck department, Arthur Vernes Institute, F-75006 Paris, France.
¹⁵ Otorhinolaryngology - Head and Neck department, AP-HP Henri Mondor Hospital, F-94010 Créteil, Île-de-France, France.
¹⁶ National Institute of Health and Medical Research, Paris-Est Creteil Val de Marne University, F-94010 Creteil, Île-de-France, France.
¹⁷ Otorhinolaryngology - Head and Neck department, Centre Hospitalier Intercommunal Créteil, F-94010 Créteil, France.
¹⁸ Otorhinolaryngology department, CHU Nantes, Nantes, France.
¹⁹ Otorhinolaryngology - Head and neck department - U1286 - INFINITE - Institute for Translational Research in Inflammation, Huriez Hospital, F-59000 Lille, France geoffrey.mortuaire@chu-lille.fr.

PMID: 38749694
PMCID: PMC11097834
DOI: 10.1136/bmjopen-2023-083112

Multicenter Study

Study protocol: the biologics in severe chronic rhinosinusitis with nasal polyps survey

Valentin Favier et al. BMJ Open. 2024.

. 2024 May 15;14(5):e083112.

doi: 10.1136/bmjopen-2023-083112.

Authors

Affiliations

¹ Otorhinolaryngology, Head and Neck Surgery and Maxillofacial Surgery department, CHU Montpellier, Montpellier, France.
² Otorhinolaryngology - Head and Neck department, Hospices civils de Lyon, F-69004 Lyon, France.
³ Otorhinolaryngology and Audiophonology department, CHU Poitiers, F-86000 Poitiers, France.
⁴ Otorhinolaryngology department, Centre Hospitalier Lyon-Sud, Pierre-Benite, France.
⁵ Otorhinolaryngology department, CHU Nice - Université Côte d'Azur, Nice, France.
⁶ Otorhinolaryngology - Head and neck department - Université Paris-Saclay, Assistance Publique - Hopitaux de Paris - Bicêtre Hospital, Paris, Île-de-France, France.
⁷ Otorhinolaryngology-Head and Neck Surgery department, CHU Bordeaux, Bordeaux, France.
⁸ Otolaryngology Head and Neck Surgery department, CHU Clermont-Ferrand, Clermont-Ferrand, France.
⁹ Otorhinolaryngology department, Assistance Publique - Hopitaux de Paris - Lariboisière Hospital, Paris, Île-de-France, France.
¹⁰ Otorhinolaryngology - Head and Neck department, Université de Lorraine, CHU Nancy, F-54000 Vandoeuvre les Nancy, France.
¹¹ EA 3450 DevAH - Développement, Adaptation et Handicap. Regulations cardio-respiratoires et de la motricité, Université de Lorraine, Vandoeuvre les Nancy, France.
¹² Otorhinolaryngology- Head and Neck department, Aix-Marseille-University, Marseille, France.
¹³ Otorhinolaryngology - Head and Neck department, Larrey Hospital, Toulouse, France.
¹⁴ Otorhinolaryngology - Head and Neck department, Arthur Vernes Institute, F-75006 Paris, France.
¹⁵ Otorhinolaryngology - Head and Neck department, AP-HP Henri Mondor Hospital, F-94010 Créteil, Île-de-France, France.
¹⁶ National Institute of Health and Medical Research, Paris-Est Creteil Val de Marne University, F-94010 Creteil, Île-de-France, France.
¹⁷ Otorhinolaryngology - Head and Neck department, Centre Hospitalier Intercommunal Créteil, F-94010 Créteil, France.
¹⁸ Otorhinolaryngology department, CHU Nantes, Nantes, France.
¹⁹ Otorhinolaryngology - Head and neck department - U1286 - INFINITE - Institute for Translational Research in Inflammation, Huriez Hospital, F-59000 Lille, France geoffrey.mortuaire@chu-lille.fr.

PMID: 38749694
PMCID: PMC11097834
DOI: 10.1136/bmjopen-2023-083112

Abstract

Introduction: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a frequent condition affecting approximately 2% of the population. Medical treatment consists long-term use of intranasal corticosteroids and short-term use of oral corticosteroids, in adjunct with saline solution rinses. Surgical management is proposed in patients who failed after medical treatment. In France, two biologics are reimbursed in case of severe uncontrolled CRSwNP despite medical treatment and endoscopic sinus surgery. Waiting for head-to-head biologics comparison, studies should report the efficacy and safety of biologics in large real-life cohorts. This study protocol describes the aims and methods of a prospective, observational, national, multicentric cohort of patients with CRSwNP treated with biologics.

Methods and analysis: The BIOlogics in severe nasal POlyposis SurvEy is a French multicentre prospective observational cohort study. The main aim is to assess the efficacy and tolerance of biologics in patients with CRSwNP, with or without association with other type 2 diseases, and to determine the strategies in case of uncontrolled disease under biologics. Patients over 18 years old requiring biologics for CRSwNP in accordance with its marketing approval in France (ie, severe nasal polyposis, with lack of control under nasal corticosteroid, systemic corticosteroids and surgery) are invited to participate. Collected data include topical history of surgical procedures and biologics, medication and use of systemic corticosteroids, visual analogical scales for specific symptoms, Sino-Nasal Outcome Test-22 questionnaire, nasal polyp score, asthma control test, Lund-Mackay score on CT scan and IgE concentration and eosinophilic count on blood sample.

Trial registration: NCT05228041/DRI_2021/0030.

Keywords: Adult otolaryngology; Asthma; Endoscopic surgery; IMMUNOLOGY.

PubMed Disclaimer

Conflict of interest statement

Competing interests: All authors report personal fees as expert consultant for Sanofi and GlaxoSmithKline.

Figures

**Figure 1**
Overview of BIOlogics in severe nasal POlyposis SurvEy study protocol. MCID, minimal clinically important difference; M, month; SCS, systemic corticosteroids; SNOT, Sino-Nasal Outcome Test-22; .

**Figure 2**
Overview of the information collected during the BIOlogics in severe nasal POlyposis SurvEy study.

See this image and copyright information in PMC

References

1. Fokkens WJ, Lund VJ, Hopkins C, et al. . European position paper on rhinosinusitis and nasal polyps 2020. Rhinology 2020;58:1–464. 10.4193/Rhin20.600 - DOI - PubMed
1. Johansson L, Akerlund A, Holmberg K, et al. . Prevalence of nasal polyps in adults: the Skövde population-based study. Ann Otol Rhinol Laryngol 2003;112:625–9. 10.1177/000348940311200709 - DOI - PubMed
1. Ahn JC, Kim JW, Lee CH, et al. . Prevalence and risk factors of chronic rhinosinusitus, allergic rhinitis, and nasal septal deviation: results of the Korean national health and nutrition survey 2008-2012. JAMA Otolaryngol Neck Surg 2016;142:162–7. 10.1001/jamaoto.2015.3142 - DOI - PubMed
1. Orlandi RR, Kingdom TT, Hwang PH, et al. . International consensus statement on allergy and rhinology: rhinosinusitis. Int Forum Allergy Rhinol 2016;6:S22–209. 10.1002/alr.21695 - DOI - PubMed
1. Klossek JM, Neukirch F, Pribil C, et al. . Prevalence of nasal Polyposis in France: a cross-sectional, case-control study. Allergy 2005;60:233–7. 10.1111/j.1398-9995.2005.00688.x - DOI - PubMed

Publication types

Actions
Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

Associated data

Actions
- Search in PubMed
- Search in ClinicalTrials.gov

LinkOut - more resources

Full Text Sources
Medical
- ClinicalTrials.gov
- MedlinePlus Health Information

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

Study protocol: the biologics in severe chronic rhinosinusitis with nasal polyps survey

Affiliations

Study protocol: the biologics in severe chronic rhinosinusitis with nasal polyps survey

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Associated data

LinkOut - more resources

Full Text Sources

Medical