Asthma Bronchiale, Chronic Rhinosinusitis (CRS), Nasal Polyposis, NSAID-Induced Asthma, NSAIDs Hypersensitivity
Conditions
Brief 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.
Interventions
OTHERObservational 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.
Sponsors
Medical University of Vienna
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sino-Nasal Outcome Test 22 (SNOT-22) score compared to early response | Historical (pre-treatment and 6 months) vs. current data (after ≥3 years of treatment) | 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 | Historical baseline and 6-month vs. current score (≥3 years post-treatment) | General quality of life at long-term follow-up, higher score means good QoL. |
| Change in Asthma Control Questionnaire (ACQ-5) score | Historical baseline and 6-month vs. current score (≥3 years post-treatment) | Asthma control evaluated via ACQ-5, high score means high disease burden. |
| Change in peripheral eosinophil count | Historical baseline and 6-month vs. current score (≥3 years post-treatment) | Long-term effect of Dupilumab on peripheral eosinophils |
| Nasal microbiome composition at long-term follow-up | Historical baseline and 6-month vs. current score (≥3 years post-treatment) | Microbial composition from nasal swabs assessed via sequencing |
Countries
Austria
Contacts
Primary ContactKarina Bayer Dr. med. univ., MD
Outcome results
None listed