NCT07049978尚未招募不适用
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)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in ASA tolerance
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Change in ASA tolerance
时间窗: 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
次要结局
- 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))
- 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))
- Change in Asthma Control Questionnaire (ACQ-5) score(Historical baseline and 6-month vs. current score (≥3 years post-treatment))
- Change in peripheral eosinophil count(Historical baseline and 6-month vs. current score (≥3 years post-treatment))
- Nasal microbiome composition at long-term follow-up(Historical baseline and 6-month vs. current score (≥3 years post-treatment))
研究者
Sven Schneider, MD
Priv.-Doz. DDr.
Medical University of Vienna
研究点 (1)
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