Actively Recruiting

Age: 18Years +
All Genders
ID06683261

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

Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-11-12

300

Participants Needed

8

Research Sites

47 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This observational study focuses on patients with chronic rhinosinusitis with nasal polyps (CRSwNP), a condition affecting 5-10% of adults and often linked to asthma and aspirin exacerbated respiratory disease. Researchers aim to learn about the real-world effectiveness of biologic treatments in managing CRSwNP, especially since these treatments target specific inflammatory processes and their results in everyday settings may differ from controlled clinical trials. The study includes patients aged 18 and older who have CRSwNP and are eligible for reimbursement of biologic treatments such as omalizumab, mepolizumab, or dupilumab. These biologics are prescribed as add-on treatments to standard care. The study tracks patients over time to assess the impact of these biologics on nasal congestion, nasal polyps, symptom severity, quality of life, asthma control, sense of smell, and treatment adherence. Participants will be followed from enrollment through up to three years of treatment. Researchers will collect patient-reported outcomes using various questionnaires and nasal endoscopy to score nasal polyps. They will monitor nasal congestion scores and other clinical measures regularly to compare real-world treatment effects with those seen in clinical trials. This helps understand how well biologics work in typical clinical practice and for which patients they are most effective.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 chronic rhinosinusitis with nasal polyps (CRSwNP).
  • Participants should fulfil the reimbursement criteria for their prescribed biological (omalizumab, mepolizumab and/or dupilumab).
Not Eligible

You will not qualify if you...

  • 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).

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 3 years

Participants receive biological add-on treatments (omalizumab, mepolizumab, or dupilumab) as part of their standard care for chronic rhinosinusitis with nasal polyps (CRSwNP).

Regular visits during treatment as part of routine care

Trial Site Locations

Total: 8 locations

1

Onze Lieve Vrouw hospital Aalst

Aalst, Belgium, 9300

Actively Recruiting

2

General hospital Sint-Jan Bruges

Bruges, Belgium, 8000

Actively Recruiting

3

University hospital Saint-Luc

Brussels, Belgium, 1200

Actively Recruiting

4

University hospital of Antwerp

Edegem, Belgium, 2650

Actively Recruiting

5

Hospital Zuid-Oost Limburg

Genk, Belgium, 3600

Actively Recruiting

6

University Hospital Brussels

Jette, Belgium, 1090

Actively Recruiting

7

University hospitals Leuven

Leuven, Belgium, 3000

Actively Recruiting

8

CHU de Liège

Liège, Belgium, 4000

Actively Recruiting

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Research Team

E

Elien Borgers, MSc

A

An-Sofie Viskens, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

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.

Claus Bachert, Jonathan Corren, Stella E Lee...

https://pubmed.ncbi.nlm.nih.gov/34970860

Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): a randomised, double-blind, placebo-controlled, phase 3 trial.

Joseph K Han, Claus Bachert, Wytske Fokkens...

https://pubmed.ncbi.nlm.nih.gov/33872587

EPOS 2012: European position paper on rhinosinusitis and nasal polyps 2012. A summary for otorhinolaryngologists.

Wytske J Fokkens, Valerie J Lund, Joachim Mullol...

https://pubmed.ncbi.nlm.nih.gov/22469599

Clinical Characteristics of Patients with Chronic Rhinosinusitis with Nasal Polyps, Asthma, and Aspirin-Exacerbated Respiratory Disease.

Whitney W Stevens, Anju T Peters, Annemarie G Hirsch...

https://pubmed.ncbi.nlm.nih.gov/28286156