A Double-Blind,Randomized, Placebo-controlled, 3-Way Cross Over Study to Evaluate the Efficacy and Safety of 14 Days TPI ASM8 in Subjects With Asthma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- Compare the AUC of the late asthmatic response (LAR) between treatments and placebo
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, 3-way crossover trial to evaluate the efficacy and safety of two different doses of inhaled TPI ASM8 administered daily for 14 days for the treatment of allergic asthma and allergen-induced asthma.
详细描述
Two doses of TPI ASM8 will be compared to placebo and look at the effect on asthmatic responses after an allergen challenge during a 3-way cross over design. Sputum inflammation , mRNA gene expression on target receptors, ECP , biomarkers of mast cells activation et PK profile will be studied.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild asthma, male and female aged 18-55 y.old
- •Steroid-naive, non-smoker
- •Dual responders
排除标准
- •Any chronic disease(unstable)
- •Immunosuppressed, recent or ongoing steroid intake
- •Methacholine PC 20 > 16 mg/mL
研究组 & 干预措施
TPI ASM8 low dose
干预措施: TPI ASM8 (Drug)
TPI ASM8 high dose
干预措施: TPI ASM8 (Drug)
Placebo
干预措施: TPI ASM8 (Drug)
结局指标
主要结局
Compare the AUC of the late asthmatic response (LAR) between treatments and placebo
时间窗: Day 14 (Between 3-7 hr post-AIC)
The area under the curve fo the late asthmatic response(% fall in FEV1)(between 3-7 hrs post allergen challenge) will be compared between the 2 doses of TPI ASM8 and the placebo
次要结局
- Compare the early and late asthmatic responses between active treatments and placebo after 14 days treatment(Day 14)
- Compare the Methacholine Hyperresponsiveness (PC20) between treatment pre and post allergen challenge(Day 13 and Day 15 (Pre & post AIC))
- Effect of ASM8 on mast cells (as measured by specific biomarkers)(Day 14 (pre, post and and peri-AIC))
- Sputum inflammation indicators (Eos, neutrophils, etc.)(Day 14 and Day 15)