EUCTR2015-002656-26-DK进行中（未招募）1 期
A Double-Blind, Randomised, Placebo-controlled, Parallel Group, International, Multi-centre Phase 2 Trial Investigating the Safety and Efficacy of CRD007 in Adult Subjects with Asthma - RSPR-008
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Written informed consent must be obtained before any trial related procedures are performed
- •2. Age =18 years old
- •3. Diagnosis of asthma according to GINA Guidelines (1)
- •4. Atopic phenotype
- •5. Treated with ICS and LABA for at least 12 weeks prior to Visit 1
- •6. Blood eosinophils =0.05*109/L at Visit 1
- •7. Demonstration of FEV1 at Visit 1 = 60% of the predicted value
- •8. Demonstration of ACQ6 = 0.5 and =2.5 at Visit 1
- •9. Reversibility demonstrated at Visit 1 or 2
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 160
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Lower respiratory tract infection <6 weeks prior to Visit 1
- •2. Smokers
- •3. Treatment with disallowed medication
- •4. Pregnant and breast-feeding female subjects
- •5. Receipt of any experimental agents within 30 days prior to Visit 1
- •6. Participation in any other interventional clinical trial during the trial period
- •7. Significant Medical history
- •8. Abnormal blood levels
- •9. Subjects known or suspected of not being able to comply with the trial-related procedures
研究者
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