Observational follow-up of standard Dupilumab treatment
Observational follow-up of standard Dupilumab treatment: Patients undergoing Dupilumab treatment for N-ERD will be observed after three to four years of treatment to assess long term 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.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Change in ASA tolerance — Historical (pre-treatment and 6 months) vs. current data (after ≥3 years of treatment) Change in aspirin tolerance assessed via oral provocation test with standardized protocol
Trial sites (1)
Facility
City
Region
Status
Medical University of Vienna
Vienna
State of Vienna
More Medical University of Vienna trials in Austria
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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