Use of DNAse in Neutrophilic Asthma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Lung Function
研究概览
简要总结
In this pilot protocol, the researchers look to determine benefits from use of nebulized rh-DNase for 4 weeks in patients with neutrophilic asthma.
详细描述
Patients with asthma of a non-Th2 phenotype have few advanced therapeutic options if their asthma remains poorly controlled despite adherence to guideline-based therapy. Currently, no targeted biologic therapies are available for neutrophilic asthma. The role of Recombinant human deoxyriboneuclease (rhDNase) has not been investigated in refractory asthma. rhDNase cleaves extracellular DNA released by neutrophils and other granulocytes, thereby reducing the viscosity of mucus. It is known that patients with asthma have higher levels of extracellular DNA than normals; however, these levels are lower than DNA levels found in the sputum of patients with cystic fibrosis. The benefits of rhDNase in cystic fibrosis have been well described. In these patients, use of daily nebulized rhDNase has shown improvement in lung function and reduction in exacerbations. Very little is known about DNAse use in asthmatics. Case reports have shown benefit when used in acute asthma exacerbations, but there are no data on its use as a therapy for neutrophilic asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •i. Able to read and sign an Informed Consent Form (ICF)
- •ii. At least Age 18
- •iii. Diagnosis of Asthma with previous source documentation of PC 20 ≤ 16 mg/dl measured by FEV1 and/or reversibility with albuterol of ≥12% in FEV1
- •iv. pre-bronchodilator Forced Vital Capacity (FVC) less than 85% predicted AND Serum total MMP9 ≥ 1800 (cut off determined by previous clinical investigation- Medimmune) OR serum IL-8> 20 pg/ml OR Sputum extracellular DNA ≥ 3.8 µg/mL OR Sputum Neutrophils > 40%
排除标准
- •i. Pregnancy
- •ii. Current smoker, smoking within the past year or pack/year history ≥ 10
- •iii. Respiratory infection within past 6 weeks
- •iv. Antibiotics within the past 4 weeks
- •v. Active lung disease other than asthma
- •vi. Cancer within the past 5 years (excluding basal cell skin cancer)
- •vii. Chronic infection due to HIV, HBV, or HCV
- •viii. Hematologic or autoimmune disease
- •ix. Unable to safely undergo bronchoscopy as determined by primary or study doctor.
研究组 & 干预措施
Intervention
rhDNAse 2.5 mg nebulizer daily for 4 weeks
干预措施: RhDNAse Inhalation Solution (Drug)
结局指标
主要结局
Lung Function
时间窗: 4 weeks
FEV1
Symptom Control
时间窗: 4 weeks
Asthma Control Test
次要结局
未报告次要终点