Phase 4 Study of Budesonide for Emergency Treatment of Acute Wheezing in Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pulmonary index score at 2 to 4 hours
研究概览
简要总结
The purpose of this study is to determine if adding nebulized budesonide to the systemic steroid for treatment of acute wheezing has any additive benefit in the emergency room.
详细描述
Context: Inhaled steroids reduced admission rates in patients with acute asthma, but it is unclear if there is a benefit of inhaled corticosteroids when used in addition to systemic corticosteroids. There is insufficient evidence that inhaled corticosteroids result in clinically important changes in pulmonary function or clinical scores when used in acute asthma. Similarly, it was mentioned in the Cochrane Database of Systematic Reviews that further research is needed to clarify if there is a benefit of inhaled corticosteroids when used in addition to systemic steroids.
Objective
To determine if adding nebulized budesonide to the systemic steroid for treatment of acute wheezing in the emergency room has any benefit on, symptom score, hospitalization rate and time to discharge from emergency room.
Study Design/Setting/Participants: A double-blind, randomized, controlled trial of nebulized budesonide versus placebo for children 6 months to 6 years of age who have admitted to the emergency room for acute wheezing.
Intervention: Participants will receive standard therapy including SCS, albuterol, and ipratropium bromide and will be randomly assigned to also receive either nebulized BIS or saline.
Study Measures: Differences in asthma scores, vital signs, and the need for hospitalization will be compared between treatment groups.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children who have recurrent wheezing attacks and admitted to the emergency room for acute wheezing
- •Pulmonary index score of 7-13
- •Parental/guardian permission (informed consent) and if appropriate, child assent
排除标准
- •Systemic corticosteroid use in the last 30 days
- •Chronic lung diseases including cystic fibrosis
- •Immunodeficiency
- •Cardiac disease requiring surgery or medications
- •Adverse drug reaction or allergy to budesonide, albuterol, ipratropium bromide, prednisone, prednisolone, or methylprednisolone
- •Known renal or hepatic dysfunction
- •Impending respiratory failure requiring positive pressure ventilation
- •Immune deficiency
- •Gastroesophageal reflux disease
- •Suspected foreign body aspiration or croup
- •Anatomic abnormalities of the respiratory tract
研究组 & 干预措施
1-Budesonide nebulized suspension
Children will receive 0.5 mg/ml budesonide nebules every 20 minutes for 3 times and will not give after 3 doses
干预措施: 0.5 mg/ml budesonide nebules (Drug)
2- 0.9% saline
Children will receive 2 ml of saline every 20 minutes for 3 times and will not give after 3 doses
干预措施: Saline (Drug)
结局指标
主要结局
Pulmonary index score at 2 to 4 hours
时间窗: 2 to 4 hours
次要结局
- Hospital admission rates(4 hours)
- Proportion of subjects improving from severe to moderate, severe to mild, and moderate to mild.(4 hours)
- Respiratory rate(2 hours)
- Oxygen saturation(2 hours)
- Time to discharge from the Emergency Department to home(2 to 4 hours)
- Adverse reactions.(2-5 days)
研究者
Cem Hasan Razi
MD
Kecioren Education and Training Hospital