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

NCT ID: NCT06683261

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-23
• Study Completion Date: 2026-12-31

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.

Detailed Description

Chronic rhinosinusitis with nasal polyps (CRSwNP) has a prevalence of 5-10% in adults. It is often associated with other comorbidities, such as asthma (30-70% of CRSwNP patients) and aspirin exacerbated respiratory disease (AERD) (16% of CRSwNP patients) leading to a significant reduced quality of life (QoL). CRSwNP is diagnosed in patients with nasal polyps who have 2 or more of the following symptoms for more than 12 weeks:

• Nasal blockage or nasal congestion
• Runny nose or postnasal drip
• Impaired sense of smell
• Facial pain/pressure. Nasal rinses, intranasal or systemic corticosteroids, long-term antibiotics, and sinus surgery are the current standard of care. However, many patients fail to achieve complete therapeutic benefit and relapse after time, even after surgery. Moreover, oral corticosteroids are associated with significant side effects, and repeated sino-nasal surgery becomes progressively more complex with higher risk of complications. Patients with CRSwNP and most patients with asthma share a common type 2 inflammatory response, characterised by elevated levels of interleukin (IL)-4, IL-5, IL-13, eosinophils, T helper 2 (Th2)cells, and type 2 innate lymphoid cells. In addition, locally produced immunoglobulin E (IgE) is able to activate mast cells and induce local inflammation in CRSwNP.

Biologicals are a specific kind of treatment with recombinant DNA-derived humanized monoclonal antibody that selectively binds specific targets in the inflammatory cascade which contributes to the pathophysiology of CRSwNP. Different biologicals have already been reimbursement for the treatment of Asthma for years, slowly these biologicals start to get their approval and reimbursement for CRSwNP. In Belgium (omalizumab (Xolair®), mepolizumab (Nucala®) and dupilumab (Dupixent ®) are reimbursed for patients with CRSwNP. Their efficacy has been demonstrated through large double-blind placebo-controlled clinical studies. However, until now only very limited reports on real-world data regarding this therapy have been published. This real-world data is important because it enables us to go beyond data gathered throughout a traditional randomised controlled trial (RCT). Traditional RCTs gather data from a controlled sample population with limited comorbidities and concomitant medications, who are likely to be compliant with the study requirements, whereas in real life patients might have poorer performance status and compliance and consist of a higher proportion of elderly patients.

Therefore, this real-world data study aims to investigate how clinical outcomes of biologic therapy in real-world application (real-world efficacy) corresponds to outcomes in clinical trials (efficacy) and to look into factors that might explain an efficacy gap.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Omalizumab

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

Intervention Type: BIOLOGICAL

Dupilumab

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

Intervention Type: BIOLOGICAL

Mepolizumab 100 mg

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Participant must be at least 18 years of age at the time of signing the informed consent.

2. Capable of giving signed informed consent.

3. Participants should have CRSwNP.

4. Participants should fulfil the reimbursement criteria for their prescribed biological (omalizumab, mepolizumab and/or dupilumab).

Exclusion Criteria

1. 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Peter Hellings

Coordinating investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter Hellings, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

Onze Lieve Vrouw hospital Aalst

Aalst, , Belgium

Site Status: RECRUITING

General hospital Sint-Jan Bruges

Bruges, , Belgium

Site Status: RECRUITING

University hospital Saint-Luc

Brussels, , Belgium

Site Status: RECRUITING

University hospital of Antwerp

Edegem, , Belgium

Site Status: RECRUITING

Hospital Zuid-Oost Limburg

Genk, , Belgium

Site Status: RECRUITING

University Hospital Brussels

Jette, , Belgium

Site Status: RECRUITING

University hospitals Leuven

Leuven, , Belgium

Site Status: RECRUITING

CHU de Liège

Liège, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Elien Borgers, MSc

Role: CONTACT

elien.borgers@uzleuven.be

003216342037

An-Sofie Viskens, MD

Role: CONTACT

an-sofie.viskens@kuleuven.be

003216348187

Facility Contacts

Principal investigator Dr. Benedicte Verhaeghe, MD

Role: primary

b.verhaeghe@yahoo.com

+3253728524

Principal Investigator Dr. K. Speleman, MD

Role: primary

kato.speleman@azsintjan.be

+3250 45 22 80

Principal investigator Prof. Valérie Hox, MD-PhD

Role: primary

valerie.hox@saintluc.uclouvain.be

+322 764 19 42

Principal investigator prof. Olivier Vanderveken, MD-PhD

Role: primary

olivier.vanderveken@uza.be

+32 3 821 30 00

Principal Investigator Dr. W. Lemmens, MD

Role: primary

winde.lemmens@zol.be

+3289/32.50.50

Principal investigator Dr. Stijn Halewyck, MD

Role: primary

stijn.halewyck@uzbrussel.be

+322 477 60 02

Elien Borgers, MSc

Role: primary

elien.borgers@uzleuven.be

+3216/34.20.37

Séverine Camby

Role: primary

s.camby@chuliege.be

+32474415961

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Other Identifiers

S66646

Identifier Type: -

Identifier Source: org_study_id