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Completed
NCT07049978
Long-term Effect of Dupilumab in N-ERD
Conditions: NSAID-Induced Asthma, NSAIDs Hypersensitivity, Chronic Rhinosinusitis (CRS), Asthma Bronchiale, Nasal Polyposis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 15
Sponsor: Medical University of Vienna
Location: Medical University of Vienna Vienna State of Vienna
Summary
This prospective observational study investigates the long-term effects of Dupilumab in patients with NSAID-exacerbated respiratory disease (N-ERD). The study assesses changes in ASA tolerance, clinical parameters, inflammatory biomarkers, quality of life, and nasal microbiome during ongoing treatment with Dupilumab. All participants are receiving Dupilumab as part of standard clinical care.
Eligibility Criteria
Inclusion Criteria:
* Participated previously in our preliminary study (EK 1044/2020) and continued Dupilumab treatment since then. Long-term use of Dupilumab since the preliminary study will be assessed based on patient self-report, as there is currently no clinical test or laboratory parameter available to objectively verify treatment duration.
* Signed and dated informed consent has been obtained
* Current therapy with Dupilumab
Exclusion Criteria:
* Pregnancy (as determined by urine ß-HCG test)
* Clinically significant abnormal laboratory values and active infection (Tbc, HIV, hepatitis A/B/C)
* History of malignancy or immunodeficiency
* Chronic obstructive lung disorders (COPD), other obstructive lung disorders (bronchiolitis)
* Need for systemic corticosteroid therapy 1 month prior to screening visit
* Eosinophilic pneumonia and Churg-Strauss Syndrome
* Previous anaphylaxis and contraindications against ASA as outlined in the official prescribing information.
Source: ClinicalTrials.gov (NCT07049978). StuddyBuddy aggregates publicly available trial information.