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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 22
- 主要终点
- Change in ICS dose
研究概览
简要总结
This is a double-blind, randomised, placebo-controlled, parallel group, Phase 2 trial evaluating CRD007 administered orally b.i.d for 14 weeks for the treatment of asthma. CRD007 will be given as add on to a background of commonly used controller medication, i.e. inhaled corticosteroid (ICS) with or without long-acting beta2-agonist (LABA). By gradually reducing the background controller medication, the efficacy and safety of CRD007 will be evaluated on top of several dose levels of this medication.
详细描述
The present trial will include subjects with diagnosed asthma. The trial involves a total of 11 visits (Visit 1-2 are screening visits, visit 3 randomisation visit, visits 4-10 treatment visits and visit 11 follow-up visit).
The subjects will be monitored by medically qualified staff every second week at clinic visits, where the reduction of their background controller medication will be reduced, if their asthma is controlled.
Between visits to the clinic the subjects have to complete a diary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Written informed consent
- •Age ≥18 years old
- •Diagnosis of asthma according to Global Initiative for Asthma (GINA) Guidelines
- •Atopic phenotype as assessed by the investigator
- •Treated with ICS and LABA for at least 12 weeks prior to Visit 1with protocol defined daily doses
- •Blood eosinophils ≥0.15*109/L at Visit 1
- •Demonstration of forced expiratory volume at one second (FEV1) >60% of the predicted value at Visit 1
- •Demonstration of ACQ6 ≥ 0.5 and ≤1.5 at Visit 1
- •Reversibility of at least 12% and 200 mL in FEV1
排除标准
- •Lower respiratory tract infection <6 weeks prior to Visit 1
- •Current smokers
- •Significant concurrent, uncontrolled medical condition as defined by the protocol
- •Others, as defined in the protocol
研究组 & 干预措施
CRD007
CRD007 (containing pemirolast sodium) tablets given twice daily for 14 weeks
干预措施: CRD007 (Drug)
Placebo
Matching placebo tablets given given twice daily for 14 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change in ICS dose
时间窗: Change of average dose of ICS, measured at visit 5 (week 8) and Visit 10 (week 18)
次要结局
未报告次要终点