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
- 4 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Tolerated aspirin dose levels as tested with different dosages (62.5mg, 125mg, 250mg and 500 mg) compared to tolerated dosages before and 6 months into Dupilumab treatment.
研究概览
简要总结
The main goal of this study is to assess the long-term effect of Dupilumab on patients with N-ERD with a special focus on the long-term effects of Dupilumab on salicylic acid tolerance. We hope to find higher rates of salicylic acid tolerant patients compared to before treatment and 6 months after treatment initiation.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Participated previously in a previous study (EK 1044/2020)
- •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
结局指标
主要结局
Tolerated aspirin dose levels as tested with different dosages (62.5mg, 125mg, 250mg and 500 mg) compared to tolerated dosages before and 6 months into Dupilumab treatment.
Tolerated aspirin dose levels as tested with different dosages (62.5mg, 125mg, 250mg and 500 mg) compared to tolerated dosages before and 6 months into Dupilumab treatment.
次要结局
- 1. Serum ECP, total IgE, allergen specific IgE, tryptase, peripheral blood eosinophils 2. Allergenic sensitization as assessed by skin prick and blood test 3. Olfactory performance 4. Prostaglandin levels in urine 5. Cytokine pattern in nasal secretions 6. Inflammatory cytokine patterns at mRNA levels 7. Nasal microbiome composition 8. TPS, VAS, SNOT-22 9. ACT, ACQ
研究者
Department of Ear, Nose and Throat Diseases, Division of General Otorhinolaryngology
Scientific
Medical University Of Vienna