A Phase 1b, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate Safety and Efficacy of Oral Zavegepant in Subjects With Mild Allergic Asthma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 45
- 试验地点
- 8
- 主要终点
- Maximum Percentage Decrease From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Any Time Between 3 and 7 Hours Post-Allergen Challenge
研究概览
简要总结
This study is a double-blind, parallel-group, randomized study of active drug vs placebo in asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with Asthma
排除标准
- 未提供
研究组 & 干预措施
BHV3500
Zavegepant 150 mg BID
干预措施: Zavegepant (Drug)
Placebo
Matching placebo 150 mg BID
干预措施: Placebo (Drug)
结局指标
主要结局
Maximum Percentage Decrease From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Any Time Between 3 and 7 Hours Post-Allergen Challenge
时间窗: Baseline (pre-allergen challenge on Day 27) and anytime between 3 and 7 hours post-challenge on Day 27
Allergen inhalation challenge was performed on Day 27 and FEV1 was measured using spirometry prior to the challenge and between 3 to 7 hours post allergen challenge to assess late asthmatic response (LAR). FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. The maximum percentage decrease was the difference between the baseline (pre-allergen challenge) FEV1 on Day 27 and lowest FEV1 between hours 3 and 7 on Day 27 divided by the baseline value from Day 27. Analysis was performed using analysis of covariance (ANCOVA) model with treatment as main effect and baseline FEV1 as covariate.
次要结局
- Maximum Percentage Decrease From Baseline in FEV1 at Any Time Between 0 and 2 Hours Post-Allergen Challenge(Baseline (pre-allergen challenge on Day 27) and anytime between 0 and 2 hours post-challenge on Day 27)
- Change in Methacholine PC20 From Pre-Allergen Challenge to Post-Allergen Challenge(From Day -15 to Day 28)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)(From start of treatment on Day 1 up to Day 41)
- Number of Participants With Clinically Significant Laboratory Test Abnormalities on Treatment(From start of treatment on Day 1 to Day 28)