NCT01653756已完成2 期
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multi-Dose, Cross-Over, Efficacy and Safety Study of Duvelisib in Mild Asthmatic Subjects Undergoing Allergen Challenge
SecuraBio1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2012年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Forced Expiratory Volume in one second (FEV1)
研究概览
简要总结
The purpose of this study is to examine the effects of multi-dose regimens of IPI-145 on lung function in mild asthmatic subjects following allergen challenge.
详细描述
This is a phase 2a, randomized, double-blind, placebo-controlled, multi-dose, 2-way cross-over study designed to examine the effect of IPI-145 on lung function and inflammatory indices in mild, allergen-reactive asthmatic subjects undergoing allergen 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female adults between 18 and 60 years of age
- •Diagnosis of asthma (mild) for at least 6 months prior to Screening
- •Forced expiratory volume in one second (FEV1) ≥70% of predicted value at Screening
- •A positive skin prick test to test allergen
排除标准
- •Any prior treatment with a phosphoinositide-3-kinase (PI3K) inhibitor other than IPI-145 in a previous clinical study
- •Acute asthma exacerbations within 6 weeks prior to Screening
- •Use of any medication for the treatment of asthma other than a short-acting β2 agonist (as needed) within the 4 weeks prior to Screening
- •Participation in another clinical study within minimum of 30 days prior to study Screening
- •A positive screen result for active or latent tuberculosis
- •A history of cardiovascular disease
- •The concomitant use of acid-reducing agents and cholinesterase inhibiting medication
- •Inadequate hepatic function defined by Aspartate Aminotransferase (AST) and/or Alanine Aminotransferase (ALT) greater than 1.5 times greater limit of normal (ULN)
- •Inadequate renal function defined by serum creatinine greater than 2.0 milligrams/dL
研究组 & 干预措施
Placebo
Placebo Comparator
Capsules
干预措施: Placebo to match IPI-145 (Drug)
IPI-145
Active Comparator
Capsules
干预措施: Placebo to match IPI-145 (Drug)
Placebo
Placebo Comparator
Capsules
干预措施: IPI-145, a PI3K Inhibitor (Drug)
IPI-145
Active Comparator
Capsules
干预措施: IPI-145, a PI3K Inhibitor (Drug)
结局指标
主要结局
Forced Expiratory Volume in one second (FEV1)
时间窗: Day 14
次要结局
- Maximum concentration (Cmax), Area Under the Curve, and terminal elimination half-life (T1/2) pre-dose and up to 12 hours post dose(Day 14)
- Number of Participants with Adverse Events as a Measure of Safety(From signing of informed consent through 21 days following study drug administration)
- Change in C-reactive Protein (CRP) levels(Screening and/or Day 1 of each treatment period)
研究者
研究点 (1)
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