NCT00973687已完成不适用
Dexamethasone Tolerability in the Treatment of Acute Asthma in Children
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 430
- 试验地点
- 1
- 主要终点
- The primary objective of this study was to assess whether smaller volumes of oral dexamethasone resulted in better tolerability, specifically less vomiting, in pediatric patients with an acute exacerbation of asthma.
研究概览
简要总结
The purpose of this study is to assess whether smaller volumes of oral dexamethasone result in better tolerability, specifically less vomiting, in pediatric patients during an acute asthma exacerbation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute asthma exacerbation
- •requiring oral systemic corticosteroids for management
排除标准
- •preference for pills over liquid formulation
- •history of Nissen fundoplication surgery
- •needed immediate airway intervention
- •require oral medications to be given via a G or J tube
- •if patient care would be compromised
- •enrolled in the study on a previous visit.
研究组 & 干预措施
1 mg/mL Ora Sweet Formulation
Experimental
no prior vomiting
干预措施: Dexamethasone (Drug)
10 mg/mL Unsweetened Formulation
Placebo Comparator
no prior vomiting
干预措施: Dexamethasone (Drug)
1 mg/mL Ora Sweet Formulation
Experimental
no prior vomiting
干预措施: Ora Sweet (Drug)
10 mg/mL Unsweetened with prior vomiting
Active Comparator
with prior vomiting
干预措施: Dexamethasone (Drug)
1 mg/mL Ora Sweet with prior vomiting
Experimental
with prior vomiting
干预措施: Ora Sweet (Drug)
1 mg/mL Ora Sweet with prior vomiting
Experimental
with prior vomiting
干预措施: Dexamethasone (Drug)
结局指标
主要结局
The primary objective of this study was to assess whether smaller volumes of oral dexamethasone resulted in better tolerability, specifically less vomiting, in pediatric patients with an acute exacerbation of asthma.
时间窗: During Emergency Department visit
次要结局
- To evaluate asthma symptom control post emergency room visit for acute asthma exacerbation.(7-14 days following emergency dept visit)
研究者
研究点 (1)
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