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

Sponsor
Universitaire Ziekenhuizen KU Leuven
Study ID
NCT06683261
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Sep 23, 2022
Status verified
Nov 2024
Primary completion
Jan 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
300 participants (estimated)

Primary Outcome Measure

To evaluate the effect of biologicals (omalizumab, mepolizumab and dupilumab) on the nasal congestion score (NCS). [ Time Frame: From enrollment until 3 years of treatment ]

Central Contacts

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