Diagnosis and management of NSAID-Exacerbated Respiratory Disease (N-ERD)-a EAACI position paper.
Marek L Kowalski, Ioana Agache, Sevim Bavbek...
https://pubmed.ncbi.nlm.nih.gov/30216468/Actively Recruiting
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-11-12
300
Participants Needed
8
Research Sites
47 weeks
Total Duration
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
Real-life Evaluation of the Efficacy of Biologicals in Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)
E
Elien Borgers, MSc
A
An-Sofie Viskens, MD
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Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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https://pubmed.ncbi.nlm.nih.gov/21605125/Universitaire Ziekenhuizen KU Leuven
Lead Sponsor