Characterization of the Role of Histamine in Children With Asthma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 211
- 试验地点
- 1
- 主要终点
- Characterize Contribution of Histamine in Children With Asthma
研究概览
简要总结
Asthma, a chronic disease which produces significant morbidity and mortality in children, is a significant health problem to a large segment of society. Despite considerable advances in the diagnosis and treatment of asthma over the past several years, a sizeable portion of patients do not respond to the "core" treatments. The investigators are now learning that the underlying pathophysiology of disease is different among patients with asthma therefore; treatments which are beneficial in some patient groups may be not achieve affect in other groups.
Antihistamines have been studied in the past for the treatment of asthma. These studies have shown that there may be a beneficial effect of antihistamines in patients with allergic asthma where histamine likely plays a large role in disease and treatment response. However, there is not enough evidence to include these drugs in the standard treatment of asthma.
The investigators hypothesize that histamine plays a definable, significant role in disease pathogenesis and treatment response in children with allergic asthma. The investigators plan to test this overall hypothesis through two specific aims. The first aim will characterize the relative contribution of histamine in allergic vs. non-allergic asthma. This aim will be accomplished by comparison of the microvasculature response to histamine in children with allergic asthma and children with non-allergic asthma, measured by histamine iontophoresis with laser Doppler (HILD) monitoring, to determine potential phenotype-associated differences in the pharmacodynamic response to histamine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children age 7-17 years old
- •with the diagnosis of allergic asthma or non-allergic asthma (n=102
排除标准
- •history of immunodeficiency, mastocytosis
- •chronic abnormal conditions of the skin, liver or kidney
- •neoplastic disease
- •movement or neurologic disorders
- •active eczema on the forearms at the time of study
- •history of a previous anaphylactic episode
- •evidence of pregnancy (by urinary hCG) or lactation at the time of the study
研究组 & 干预措施
Initial Treatment: Levocetirizine(LCT)
Group 1 will begin with active Levocetirizine(LCT) 0.5 mg/ml oral solution for 5-8 days. This arm will then undergo a 3-7 day washout period at which point crossover will occur and placebo will be provided for 5-8 days.
干预措施: Levocetirizine 0.5 Mg/mL Oral Solution (Drug)
Initial Treatment: Placebo
Group 2 will begin with placebo oral solution for 5-8 days. This arm will then undergo a 3-7 day washout period at which point crossover will occur and active Levocetirizine(LCT) 0.5 mg/ml will be provided for 5-8 days.
干预措施: Levocetirizine 0.5 Mg/mL Oral Solution (Drug)
结局指标
主要结局
Characterize Contribution of Histamine in Children With Asthma
时间窗: one year
The investigators will compare the response to histamine via histamine iontophoresis with laser doppler monitoring (measured in flux units on a continuous scale)between subjects with allergic asthma compared to subjects with non-allergic asthma.
次要结局
未报告次要终点