A Description of Inflammatory Cell Types in Moderate to Severe Pediatric Asthma: Eosinophilic and Non Eosinophilic Sputum Markers While on Anti-IgE Therapy (Xolair)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 13
- 主要终点
- Number of Participants With Change in Sputum Markers by End of Study
研究概览
简要总结
The researcher proposes to assess levels of sputum inflammatory markers (eosinophils, eosinophil cationic protein (ECP), neutrophils IL-8) before and while on anti-IgE therapy in a pediatric population of moderate to severe asthmatics who have ongoing persistent asthma symptoms despite on moderate to high doses of inhaled corticosteroids (ICS).
Associations will be assessed between the types of sputum inflammatory markers and the patient's atopic status and level of asthma control as indicated by the following measures:
- pulmonary function test (PFT)
- asthma symptoms based on the Asthma Control Test (ACT)
详细描述
Objectives:
Primary: Describe inflammatory cell types in study patients and compare changes in inflammatory cell patterns before and during anti-IgE therapy.
Secondary:Describe patterns of sputum eosinophilia and neutrophilia in relation to asthma symptom improvement based on ACT and PFT
Hypotheses:
Differences in inflammatory response after the addition of anti-IgE therapy can be described in neutrophilic, eosinophilic and neutrophilic/eosinophilic asthmatics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Moderate to severe allergic asthma, uncontrolled on conventional therapy
排除标准
- •History of systemic illness, currently on other immune modulators like immunotherapy, IVIg
- •Pregnancy
- •IgE level >1300
研究组 & 干预措施
all patients received Xolair/active drug
One arm:active drug
干预措施: ANTI-IGE THERAPY (XOLAIR) (Drug)
结局指标
主要结局
Number of Participants With Change in Sputum Markers by End of Study
时间窗: 32 weeks
sputum markers were classified as eosinophilic or non eosinophilic
次要结局
- Number Participants for Whom Sputum Induction Was Safe(every 4 weeks up to 32 weeks)
- Number of Participants With Response to Therapy Based on Clinical Parameters Such as ED Visits, Hospitalizations, Systemic Steroid Use and Symptom Control(32 weeks)
研究者
MARIPAZ B. MORALES MD
MD
Children's Hospital of The King's Daughters