About this trial

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

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Observational follow-up of standard Dupilumab treatment

Treatment groups

30 Participants
are divided into 1 treatment group

Locations

1
Medical University of Vienna1090, ViennaState of Vienna, Austria

Sponsors and collaborators

Medical University of Vienna

Lead sponsor