Phase 4 Study of Nebulized Budesonide for Children Who Are Hospitalized for Acute Wheezing
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
- Time to discharge from the hospital to home
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 children who have hospitalized for acute wheezing.
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 hospitalized children has any benefit on, symptom score, duration of hospitalization and time to discharge from hospital.
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 hospital 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, duration of hospitalization and time to discharge from hospital 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
- •Children who admitted to the hospital for acute wheezing
- •Clinical asthma score of 3-9
- •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
This arm consist 50 children with recurrent wheezing who are hospitalized for wheezing epizode. They received 1 mg nebulized budesonide 2 times a day upto 5 days
干预措施: Budesonide 0.5 mg/ml nebules (Drug)
2 Placebo saline
This arm consist 50 children with recurrent wheezing who are hospitalized for wheezing epizode. They received 2ml of nebulized saline 2 times a day upto 5 days
干预措施: % 0.9 Saline solution (Drug)
结局指标
主要结局
Time to discharge from the hospital to home
时间窗: 1-5 days
次要结局
- Pulmonary index score(1 to 5 days)
- Oxygen saturation(1 to 5 days)
- Adverse reactions.(1 to 5 days)
- Respiratory rate(1 to 5 days)
研究者
Cem Hasan Razi
MD
Kecioren Education and Training Hospital