NCT02474017已完成1 期
An Open Study to Assess the Robustness of the CRC749 Device by Pharmaceutical Performance Following Twice Daily Dosing of MGR001 Administered Via Oral Inhalation in Subjects With Asthma or Chronic Obstructive Pulmonary Disease (COPD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- In vitro Measurement of Emitted Dose
研究概览
简要总结
To confirm the robustness of the CRC749 inhaler.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females at least 12 years of age.
- •A clinical diagnosis for at least 12 weeks prior to screening of asthma or COPD and stable treatment.
- •Spirometry following salbutamol showing FEV1 ≥40% of predicted normal and FEV1/FVC ratio <0.7 for COPD subjects.
- •Spirometry without salbutamol showing FEV1 ≥50% of predicted normal for asthma subjects.
- •Ability to use the CRC749 inhaler.
排除标准
- •Other chronic or active respiratory disorder or symptoms of, or treatment for a COPD or asthma exacerbation during the 28 days preceding screening.
- •History of long QT syndrome or screening ECG with QTcF greater than 480 milliseconds.
- •Current evidence of, or history within the 6 months prior to screening of unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, or myocardial infarction.
- •Subjects in whom Advair(R) Diskus(R) / Seretide(R) Accuhaler(R) are contra-indicated.
研究组 & 干预措施
MGR001
Experimental
MGR001 (FP/Salmeterol) (250/50 µg) twice daily (BID)
干预措施: MGR001 (Drug)
MGR001
Experimental
MGR001 (FP/Salmeterol) (250/50 µg) twice daily (BID)
干预措施: CRC749 inhaler (Device)
结局指标
主要结局
In vitro Measurement of Emitted Dose
时间窗: 3 Weeks
CRC749 inhaler robustness will be assessed by in vitro testing of the CRC749 inhaler after 3 weeks of patient use of the MGR001 product.
次要结局
- Adverse Events(3 Weeks)
研究者
研究点 (1)
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