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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N-ERD patients with long-term Dupilumab treatment | Patients diagnosed with N-ERD undergoing Dupilumab treatment between 3 and 4 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational follow-up of standard Dupilumab treatment | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ASA tolerance | Change in aspirin tolerance assessed via oral provocation test with standardized protocol | Historical (pre-treatment and 6 months) vs. current data (after ≥3 years of treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Historical (pre-treatment and 6 months) vs. current data (after ≥3 years of treatment) |
| Change in European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L) score compared to early response |
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Inclusion Criteria:
Exclusion Criteria:
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Adults with NSAID-exacerbated respiratory disease (NERD), previously included in a Dupilumab follow-up study, now being evaluated after ≥3 years of treatment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karina Bayer Dr. med. univ., MD | Contact | 014040033480 | karina.bayer@meduniwien.ac.at |
| Name | Affiliation | Role |
|---|---|---|
| Sven Schneider Dr. med. univ., MD | Senior doctor and Department of Otorhinolaryngology at Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Vienna | State of Vienna | 1090 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36549708 | Background | Schneider S, Poglitsch K, Morgenstern C, Quint T, Gangl K, Sinz C, Bartosik T, Campion NJ, Liu DT, Landegger LD, Tu A, Stanek V, Rocha-Hasler M, Bangert C, Eckl-Dorna J. Dupilumab increases aspirin tolerance in NSAID-exacerbated respiratory disease. Eur Respir J. 2023 Mar 16;61(3):2201335. doi: 10.1183/13993003.01335-2022. Print 2023 Mar. |
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| ID | Term |
|---|---|
| D055963 | Asthma, Aspirin-Induced |
| D009298 | Nasal Polyps |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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|
General quality of life at long-term follow-up, higher score means good QoL. |
| Historical baseline and 6-month vs. current score (≥3 years post-treatment) |
| Change in Asthma Control Questionnaire (ACQ-5) score | Asthma control evaluated via ACQ-5, high score means high disease burden. | Historical baseline and 6-month vs. current score (≥3 years post-treatment) |
| Change in peripheral eosinophil count | Long-term effect of Dupilumab on peripheral eosinophils | Historical baseline and 6-month vs. current score (≥3 years post-treatment) |
| Nasal microbiome composition at long-term follow-up | Microbial composition from nasal swabs assessed via sequencing | Historical baseline and 6-month vs. current score (≥3 years post-treatment) |
| D006969 |
| Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D004342 | Drug Hypersensitivity |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D009668 | Nose Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |