A Double-Blind, Randomised, Placebo-controlled, Cross-over, Phase 2 Mannitol Challenge Trial, Investigating the 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
- 24
- 试验地点
- 2
- 主要终点
- PD15 for mannitol after treatment with CRD007 and placebo
研究概览
简要总结
This is a double-blind, randomised, placebo-controlled, cross-over, Phase 2 trial evaluating two doses (a low and a high) of CRD007 for the treatment of asthmatic trial subjects with a positive asthma test (mannitol challenge) prior to enrolment.
详细描述
The present trial will include subjects with diagnosed asthma in a provocation model which mimics assessments of asthma control. Mannitol challenge is an indirect asthma provocation test, which requires the presence of inflammatory cells, particularly mast cells, in the airways.
The trial involved in total 5 subject visits and will last for a maximum of 30 days for each subject from Visit 2 (Randomisation) to Visit 5 (Follow up).
Visit 2,3, and 4 will be treatment visits where Investigational Medicinal Product (IMP) is administrated 3 hours before the Mannitol challenge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Age ≥18 and <50 years
- •Diagnosis of asthma
排除标准
- •Clinical significant comorbidities
- •Lower respiratory tract infection <6 weeks prior to Visit 1
- •Others, as specified in the protocol
研究组 & 干预措施
Placebo
Matching placebo tables are given as a single dose
干预措施: Placebo (Other)
CRD007 Low dose
"Low dose" of CRD007 (pemirolast sodium) given as a single dose
干预措施: CRD007 (Drug)
CRD007 High dose
"High dose" CRD007 (pemirolast sodium) given as a single dose
干预措施: CRD007 (Drug)
结局指标
主要结局
PD15 for mannitol after treatment with CRD007 and placebo
时间窗: Forced expiratory volume at one second (FEV1) manoeuvres are performed 60 seconds after each dose
The FEV1 value taken after the 0 mg capsule is taken as pre-challenge FEV1 and used to calculate the percentage decrease in FEV1 in response to the mannitol challenge. The test ends when the FEV1 has fallen by 15% or more (PD15)
次要结局
未报告次要终点