Long-term Effect of Dupilumab in N-ERD

Официальное название

Long-term Effect of Dupilumab on Acetylsalicylic Acid (ASA) Intolerance and Its Mechanisms in Patients With Non-steroidal Anti-inflammatory Drug-exacerbated Respiratory Disease (N-ERD)

Обзор

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Change in ASA tolerance [Срок оценки: Historical (pre-treatment and 6 months) vs. current data (after ≥3 years of treatment)]

Вторичные конечные точки (5)

• Change in Sino-Nasal Outcome Test 22 (SNOT-22) score compared to early response [Срок оценки: 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 [Срок оценки: Historical baseline and 6-month vs. current score (≥3 years post-treatment)]
• Change in Asthma Control Questionnaire (ACQ-5) score [Срок оценки: Historical baseline and 6-month vs. current score (≥3 years post-treatment)]
• Change in peripheral eosinophil count [Срок оценки: Historical baseline and 6-month vs. current score (≥3 years post-treatment)]
• Nasal microbiome composition at long-term follow-up [Срок оценки: Historical baseline and 6-month vs. current score (≥3 years post-treatment)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Австрия · 1 центр

• Medical University of Vienna — Vienna

Публикации

• 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. PMID 36549708

Идентификаторы

NCT: NCT07049978 · DUPI-NERD-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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