Reduction of IgE Antibody in Human Allergic Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- CBER ID50 skin test result
研究概览
简要总结
The purpose of this study is to determine whether a neuropeptide, substance P, when injected along with an allergen, such as ragweed, can reduce allergic reactivity.
详细描述
Allergic Rhinitis (Hay fever) affects many children and adults and is a risk factor for development of asthma. This study utilizes the neurotransmitter, substance P, a small molecule which is present in nerve endings, the brain, skin, lungs and the gastrointestinal tract. Subjects will receive substance P and a low dosage of an allergen, such as ragweed in an attempt to reduce allergic reactivity.
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
- Single (Participant)
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
- •positive immediate type skin test to ragweed or grass pollen or a third (standardized) allergen if both ragweed and grass pollen allergen are not positive
- •volunteers should be available for allergen injections and then cutaneous titrations for approximately 1 year from the start of the enrollment period
排除标准
- •volunteer is pregnant or lactating
- •abnormal electrocardiogram for subjects over 50 years of age
- •use of beta adrenergic antagonists or tricyclic antidepressants
研究组 & 干预措施
substance P-low/moderate dose allergen
substance P with 16 sequential increasing doses of allergen
干预措施: substance P (Biological)
placebo-placebo
substance P placebo and allergen placebo (weekly)
干预措施: substance P (Biological)
substance P-low dose allergen
Substance P injections with 8 sequential, increasing doses of allergen
干预措施: substance P (Biological)
substance P-moderate dose allergen
Substance P with sequential, increasing doses of allergen
干预措施: substance P (Biological)
substance P-low dose allergen
Substance P injections with 8 sequential, increasing doses of allergen
干预措施: substance P injections (Biological)
substance P-moderate dose allergen
Substance P with sequential, increasing doses of allergen
干预措施: substance P injections (Biological)
substance P-low/moderate dose allergen
substance P with 16 sequential increasing doses of allergen
干预措施: substance P injections (Biological)
substance P-placebo
Placebo injections of substance P and placebo
干预措施: substance P injections (Biological)
substance P-placebo
Placebo injections of substance P and placebo
干预措施: substance P (Biological)
placebo-low dose allergen
Placebo injections with 8 sequential increasing low dose allergen injections
干预措施: substance P injections (Biological)
placebo-placebo
substance P placebo and allergen placebo (weekly)
干预措施: substance P injections (Biological)
placebo-low dose allergen
Placebo injections with 8 sequential increasing low dose allergen injections
干预措施: substance P (Biological)
结局指标
主要结局
CBER ID50 skin test result
时间窗: 1 to 6 months after completing injections
The ID50 skin test result utilizes FDA CBER methodology to determine the change in allergic skin reactivity to ragweed and grass pollen allergens.
次要结局
未报告次要终点
研究者
Paul Greenberger
Professor of Medicine
Northwestern University