Real-life Evaluation of the Efficacy of Biologicals in Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)

NCT06683261 | Recruiting

• 1 other identifier: S66646
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 8

Brief Summary

The goal of this observational study is to learn more about the real-world efficacy of biologics in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP). All patients who are 18 years or older, who have CRSwNP and are eligible for reimbursement of a biological for the indication of CRSwNP can be included. The main question is the efficacy of biologics in real life after 24 weeks. The main focus are patient reported outcomes measured via several questionnaires and the nasal polyp score, scored with nasal endoscopy.

Conditions

Chronic Rhinosinusitis With Nasal Polyps (CRSwNP); Chronic Rhinosinusitis (CRS)

Keywords

biologicals; CRSwNP; real-world data study; mepolizumab; omalizumab; dupilumab

Outcome Measures

Primary Outcomes (1)

• To evaluate the effect of biologicals (omalizumab, mepolizumab and dupilumab) on the nasal congestion score (NCS).

  Nasal congestion is scored from 0 ("No symptoms") to 3 ("Severe symptoms"). Higher scores denote greater symptom severity. Changes from baseline in NCS will be measured at 1, 3 and 6 months and 1, 1.5, 2 and 3 years for every biological (mepolizumab, omalizumab and dupilumab).

  From enrollment until 3 years of treatment

Secondary Outcomes (7)

• To evaluate the effect of biologicals (omalizumab, mepolizumab and dupilumab) on the nasal polyp score (NPS).

  From enrollment until 3 years of treatment

• To evaluate the effect of biologicals (omalizumab, mepolizumab and dupilumab) on the Visual analogue scale (VAS).

  From enrollment until 3 years of treatment

• To evaluate the effect of biologicals (omalizumab, mepolizumab and dupilumab) on the Sino-Nasal Outcome Test-22 items (SNOT-22).

  From enrollment until 3 years of treatment

• To compare the effect of biologicals (omalizumab, mepolizumab and dupilumab) on the asthma control questionnaires 5-item version(ACQ-5).

  From enrollment until 3 years of treatment

• To compare the effect of biologicals (omalizumab, mepolizumab and dupilumab) on the asthma quality of life questionnaire (AQLQ).

  From enrollment until 3 years of treatment

Other Outcomes (1)

• To characterise non-responders to any biological treatment.

  from enrolment until 3 years of treatment

Interventions

Omalizumab BIOLOGICAL

biological prescribed as add-on treatment as part of the standard of care

Dupilumab BIOLOGICAL

biological prescribed as add-on treatment as part of the standard of care

Mepolizumab 100 mg BIOLOGICAL

biological prescribed as add-on treatment as part of the standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with CRSwNP that are prescribed a biological in the outpatient clinic of several ENT departments across Belgium

You may qualify if:

• Participant must be at least 18 years of age at the time of signing the informed consent.
• Capable of giving signed informed consent.
• Participants should have CRSwNP.
• Participants should fulfil the reimbursement criteria for their prescribed biological (omalizumab, mepolizumab and/or dupilumab).

You may not qualify if:

• \. Patients treated with other biological therapies in the 3 months prior to the current biological (this is not applicable to patients who are in the trial and switch biological).

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (8)

Onze Lieve Vrouw hospital Aalst

Aalst, 9300, Belgium

RECRUITING

General hospital Sint-Jan Bruges

Bruges, 8000, Belgium

RECRUITING

University hospital Saint-Luc

Brussels, 1200, Belgium

RECRUITING

University hospital of Antwerp

Edegem, 2650, Belgium

RECRUITING

Hospital Zuid-Oost Limburg

Genk, 3600, Belgium

RECRUITING

University Hospital Brussels

Jette, 1090, Belgium

RECRUITING

University hospitals Leuven

Leuven, 3000, Belgium

RECRUITING

CHU de Liège

Liège, 4000, Belgium

RECRUITING

Related Publications (12)

• Kilty SJ, Lasso A. Canadian real-world study of access and clinical results using dupilumab for chronic rhinosinusitis with polyps. J Otolaryngol Head Neck Surg. 2022 Apr 25;51(1):17. doi: 10.1186/s40463-022-00570-0.

  PMID: 35468866 BACKGROUND

• Bachert C, Corren J, Lee SE, Zhang H, Harel S, Cunoosamy D, Khan AH, Jacob-Nara JA, Siddiqui S, Nash S, Rowe PJ, Deniz Y. Dupilumab efficacy and biomarkers in chronic rhinosinusitis with nasal polyps: Association between dupilumab treatment effect on nasal polyp score and biomarkers of type 2 inflammation in patients with chronic rhinosinusitis with nasal polyps in the phase 3 SINUS-24 and SINUS-52 trials. Int Forum Allergy Rhinol. 2022 Sep;12(9):1191-1195. doi: 10.1002/alr.22964. Epub 2022 Jan 31. No abstract available.

  PMID: 34970860 BACKGROUND

• Han JK, Bachert C, Fokkens W, Desrosiers M, Wagenmann M, Lee SE, Smith SG, Martin N, Mayer B, Yancey SW, Sousa AR, Chan R, Hopkins C; SYNAPSE study investigators. Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med. 2021 Oct;9(10):1141-1153. doi: 10.1016/S2213-2600(21)00097-7. Epub 2021 Apr 16.

  PMID: 33872587 BACKGROUND

• Gevaert P, Omachi TA, Corren J, Mullol J, Han J, Lee SE, Kaufman D, Ligueros-Saylan M, Howard M, Zhu R, Owen R, Wong K, Islam L, Bachert C. Efficacy and safety of omalizumab in nasal polyposis: 2 randomized phase 3 trials. J Allergy Clin Immunol. 2020 Sep;146(3):595-605. doi: 10.1016/j.jaci.2020.05.032. Epub 2020 Jun 7.

  PMID: 32524991 BACKGROUND

• Zhang N, Holtappels G, Gevaert P, Patou J, Dhaliwal B, Gould H, Bachert C. Mucosal tissue polyclonal IgE is functional in response to allergen and SEB. Allergy. 2011 Jan;66(1):141-8. doi: 10.1111/j.1398-9995.2010.02448.x.

  PMID: 20659077 BACKGROUND

• Tomassen P, Vandeplas G, Van Zele T, Cardell LO, Arebro J, Olze H, Forster-Ruhrmann U, Kowalski ML, Olszewska-Ziaber A, Holtappels G, De Ruyck N, Wang X, Van Drunen C, Mullol J, Hellings P, Hox V, Toskala E, Scadding G, Lund V, Zhang L, Fokkens W, Bachert C. Inflammatory endotypes of chronic rhinosinusitis based on cluster analysis of biomarkers. J Allergy Clin Immunol. 2016 May;137(5):1449-1456.e4. doi: 10.1016/j.jaci.2015.12.1324. Epub 2016 Mar 4.

  PMID: 26949058 BACKGROUND

• Fokkens WJ, Lund VJ, Mullol J, Bachert C, Alobid I, Baroody F, Cohen N, Cervin A, Douglas R, Gevaert P, Georgalas C, Goossens H, Harvey R, Hellings P, Hopkins C, Jones N, Joos G, Kalogjera L, Kern B, Kowalski M, Price D, Riechelmann H, Schlosser R, Senior B, Thomas M, Toskala E, Voegels R, Wang de Y, Wormald PJ. EPOS 2012: European position paper on rhinosinusitis and nasal polyps 2012. A summary for otorhinolaryngologists. Rhinology. 2012 Mar;50(1):1-12. doi: 10.4193/Rhino12.000.

  PMID: 22469599 BACKGROUND

• Stevens WW, Peters AT, Hirsch AG, Nordberg CM, Schwartz BS, Mercer DG, Mahdavinia M, Grammer LC, Hulse KE, Kern RC, Avila P, Schleimer RP. Clinical Characteristics of Patients with Chronic Rhinosinusitis with Nasal Polyps, Asthma, and Aspirin-Exacerbated Respiratory Disease. J Allergy Clin Immunol Pract. 2017 Jul-Aug;5(4):1061-1070.e3. doi: 10.1016/j.jaip.2016.12.027. Epub 2017 Mar 9.

  PMID: 28286156 BACKGROUND

• Dudvarski Z, Djukic V, Janosevic L, Tomanovic N, Soldatovic I. Influence of asthma on quality of life and clinical characteristics of patients with nasal polyposis. Eur Arch Otorhinolaryngol. 2013 Mar;270(4):1379-83. doi: 10.1007/s00405-012-2242-x. Epub 2012 Nov 8.

  PMID: 23135235 BACKGROUND

• Kowalski ML, Agache I, Bavbek S, Bakirtas A, Blanca M, Bochenek G, Bonini M, Heffler E, Klimek L, Laidlaw TM, Mullol J, Nizankowska-Mogilnicka E, Park HS, Sanak M, Sanchez-Borges M, Sanchez-Garcia S, Scadding G, Taniguchi M, Torres MJ, White AA, Wardzynska A. Diagnosis and management of NSAID-Exacerbated Respiratory Disease (N-ERD)-a EAACI position paper. Allergy. 2019 Jan;74(1):28-39. doi: 10.1111/all.13599. Epub 2018 Oct 2.

  PMID: 30216468 BACKGROUND

• Khan A, Vandeplas G, Huynh TMT, Joish VN, Mannent L, Tomassen P, Van Zele T, Cardell LO, Arebro J, Olze H, Foerster-Ruhrmann U, Kowalski ML, Olszewska-Ziaber A, Holtappels G, De Ruyck N, van Drunen C, Mullol J, Hellings PW, Hox V, Toskala E, Scadding G, Lund VJ, Fokkens WJ, Bachert C. The Global Allergy and Asthma European Network (GALEN rhinosinusitis cohort: a large European cross-sectional study of chronic rhinosinusitis patients with and without nasal polyps. Rhinology. 2019 Feb 1;57(1):32-42. doi: 10.4193/Rhin17.255.

  PMID: 29911211 BACKGROUND

• Hastan D, Fokkens WJ, Bachert C, Newson RB, Bislimovska J, Bockelbrink A, Bousquet PJ, Brozek G, Bruno A, Dahlen SE, Forsberg B, Gunnbjornsdottir M, Kasper L, Kramer U, Kowalski ML, Lange B, Lundback B, Salagean E, Todo-Bom A, Tomassen P, Toskala E, van Drunen CM, Bousquet J, Zuberbier T, Jarvis D, Burney P. Chronic rhinosinusitis in Europe--an underestimated disease. A GA(2)LEN study. Allergy. 2011 Sep;66(9):1216-23. doi: 10.1111/j.1398-9995.2011.02646.x. Epub 2011 May 24.

  PMID: 21605125 BACKGROUND

MeSH Terms

Interventions

Omalizumab; dupilumab; mepolizumab

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• Peter Hellings, MD,PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elien Borgers, MSc

CONTACT

003216342037; elien.borgers@uzleuven.be

An-Sofie Viskens, MD

CONTACT

003216348187; an-sofie.viskens@kuleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating investigator

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: November 12, 2024
• Study Start: September 23, 2022
• Primary Completion: January 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 12, 2024

Record last verified: 2024-11

Locations

BE (8)