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.
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
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)
Adults with NSAID-exacerbated respiratory disease (NERD), previously included in a Dupilumab follow-up study, now being evaluated after ≥3 years of treatment.
Cohort
Prospective
Observational follow-up of standard Dupilumab treatment
Other interventionPatients 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.
Change in ASA tolerance
Change in aspirin tolerance assessed via oral provocation test with standardized protocol
Change in Sino-Nasal Outcome Test 22 (SNOT-22) score compared to early response
Sinonasal symptoms assessed with SNOT-22 questionnaire at long-term follow-up, higher score means higher limitation by disease.
Change in European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L) score compared to early response
General quality of life at long-term follow-up, higher score means good QoL.
Change in Asthma Control Questionnaire (ACQ-5) score
Asthma control evaluated via ACQ-5, high score means high disease burden.
Change in peripheral eosinophil count
Long-term effect of Dupilumab on peripheral eosinophils
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This trial is not recruiting at the moment. You can still explore other options:
