A Pilot Study to Evaluate the Effect of Nebulized Budesonide and Oral Corticosteroids on Wheezing Episode Relapse in Pediatric Patients Following Discharge From the Emergency Department/Outpatient Care Facility
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Wheezing/Asthma/Bronchospasm Relapse Rate
研究概览
简要总结
Subjects aged 1-8 years who have been discharged from the emergency department/outpatient care facility with a diagnosis of asthma/bronchospasm/wheezing after usual standard care will be enrolled into this open-label, randomized, parallel-group study to compare the efficacy of nebulized budesonide and oral corticosteroids in preventing asthma exacerbation relapse rates during the 21-day follow-up period.
详细描述
Secondary outcomes include urinary cortisol-creatinine rations, symptom severity scores and peak flow rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children ages 1-8 years old
- •Discharge from emergency department/outpatient clinic with a diagnosis of asthma exacerbation after usual standard care
- •Subjects must be able to show efficient use with a jet nebulizer
排除标准
- •Subjects requiring hospitalization
- •Subjects receiving oral steroids 1 week prior to presentation to emergency department.
- •Subjects with FEV1 < 50% of predicted
- •Subjects with co-morbid medical conditions (renal or cardiovascular disease)
- •Subjects with reported history of HIV
- •Subjects unable to follow up for study visits
- •Subjects who are frequently enuretic
研究组 & 干预措施
Treatment with Budesonide
Subject is treated with nebulized budesonide 0.5 BID for 3 weeks
干预措施: Nebulized Budesonide (Drug)
Usual care
Subject is treated with usual care as provided by the doctor. Usual care normally consists of treatment with albuterol with or without an oral steroid.
干预措施: Usual care (albuterol with or without oral steroid) (Drug)
结局指标
主要结局
Wheezing/Asthma/Bronchospasm Relapse Rate
时间窗: 3 weeks
This was defined as the percentage of subjects in each group (treatment with budesonide versus usual care) having an unscheduled acute visit to primary care, urgent care or an emergency department during the study period.
次要结局
- Forced Expiratory Volume in 1 Second (FEV1)(3 weeks)
- Urinary Cortisol Levels(3 weeks)
研究者
Deborah Gentile
Co-Investigator
West Penn Allegheny Health System