试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 30
- 试验地点
- 7
- 主要终点
- Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Day 35
研究概览
简要总结
Primary purpose of the protocol is to determine if IMA-638 prevents a mild asthma attack by a subject with mild asthma inhaling an allergen.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Inclusion Criteria:
- •generally healthy, men and women with mild allergic asthma, aged 18 to 60 years
- •only asthma med is short-acting bronchodilator used not more than twice weekly
- •FEV1 greater than 70% predicted and a demonstrated baseline late response to allergen induction
排除标准
- 未提供
结局指标
主要结局
Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Day 35
时间窗: Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Day 35
Allergen inhalation test was performed at Screening, Day 14 and 35 to elicit airway responses similar to those that follow natural allergen exposure. FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. LAR was characterized by a fall in FEV1 of more than or equal to (\>=) 15 percent (%) at 3 to 7 hours post-allergen inhalation. Maximum drop in FEV1 relative to the pre-allergen baseline FEV1 between 3 to 7 hours on Day 35 was reported. Pre-allergen baseline FEV1 was performed in triplicate using spirometry and the best of the 3 values was selected.
Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Screening
时间窗: Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Screening (Day -14)
Allergen inhalation test was performed at Screening, Day 14 and 35 to elicit airway responses similar to those that follow natural allergen exposure. FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. LAR was characterized by a fall in FEV1 of more than or equal to (\>=) 15 percent (%) at 3 to 7 hours post-allergen inhalation. Maximum drop in FEV1 relative to the pre-allergen baseline FEV1 between 3 to 7 hours at Screening was reported. Pre-allergen baseline FEV1 was performed in triplicate using spirometry and the best of the 3 values was selected.
Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Day 14
时间窗: Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Day 14
Allergen inhalation test was performed at Screening, Day 14 and 35 to elicit airway responses similar to those that follow natural allergen exposure. FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. LAR was characterized by a fall in FEV1 of more than or equal to (\>=) 15 percent (%) at 3 to 7 hours post-allergen inhalation. Maximum drop in FEV1 relative to the pre-allergen baseline FEV1 between 3 to 7 hours on Day 14 was reported. Pre-allergen baseline FEV1 was performed in triplicate using spirometry and the best of the 3 values was selected.
次要结局
- Change From Pre-allergen Challenge in Provocative Concentration of Methacholine Causing a 20% Fall in FEV1 (PC20) to Post-allergen Challenge For Screening, Day 14 and 35 Challenge(Day -15, -13 for Screening (Day -14) challenge; Day 13, 15 for Day 14 challenge; Day 34, 36 for Day 35 challenge)
- Change From Baseline in Total Blood Eosinophil Counts at Day 8, 13, 21, 34, 56, 84 and 168(Baseline, Day 8, 13, 21, 34, 56, 84, 168)
- Blood Levels of Interleukin-13 (IL-13)(Screening, baseline, Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168)
- Messenger Ribonucleic Acid (mRNA) Gene Expression in Sputum and Blood(Screening (Day-13, -14, -15), Day 1, 13, 14, 15, 34, 35, 36, 112)
- Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Early-Phase Asthma Response (EAR) at Screening, Day 14 and 35(Pre-allergen baseline, 10, 20, 30, 45, 60, 90, 120, 180 minutes post-allergen inhalation Screening, Day 14, 35)
- Change From Baseline in Total and Differential Sputum Cell Counts at Day 14 and 35(Baseline, Day 14, 35)
- Total Blood Eosinophil Counts at Baseline(Baseline)
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for IMA-638(Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168)
- Serum Decay Half-Life (t1/2) for IMA-638(Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168)
- Number of Participants With Antibodies to IMA-638(Baseline up to Day 168)
- Area Under the Percent Drop in Forced Expiratory Volume in 1 Second Curve (AUC FEV1) From Time 3 to 7 Hours for Late-Phase Asthma Response (LAR)(Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Screening (Day -14), Day 14, 35)
- Area Under the Percent Drop in Forced Expiratory Volume in 1 Second Curve (AUC FEV1) From Time 0 to 3 Hours for Early-Phase Asthma Response (EAR)(Pre-allergen baseline, 10, 20, 30, 45, 60, 90, 120, 180 minutes post-allergen inhalation Screening, Day 14, 35)
- Allergen Specific and Total Immunoglobulin E (IgE) Count at Baseline(Baseline)
- Change From Baseline in Allergen Specific and Total Immunoglobulin E (IgE) Count at Day 13, 34, 56, 112 and 168(Baseline, Day 13, 34, 56, 112, 168)
- Protein Expression in Sputum and Blood(Screening (Day-13, -14, -15), Day 1, 13, 14, 15, 34, 35, 36, 112)
- Maximum Observed Serum Concentration (Cmax) for IMA-638(Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168)
- Time to Reach Maximum Observed Serum Concentration (Tmax) for IMA-638(Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] for IMA-638(Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168)