Phase 4 Study of Single Dose of Oral Montelukast When Adding to Standard Treatment in Acute Moderate to Severe Wheezing in Preschool Children.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Difference of pulmonary index score from baseline to 120 minutes.
研究概览
简要总结
The purpose of this study is to determine if adding single dose of oral montelukast to the standard treatment of systemic glucocorticoids plus short acting beta-2 agonist for treatment of acute wheezing provide additional clinical benefit in the emergency room.
详细描述
Systemic corticosteroids and short acting beta-2 agonists are the mainstay treatment of acute asthma, however, little data exists regarding use of leukotriene antagonists in acute asthma. A few studies in adults have shown that oral montelukast also improved pulmonary function when being added to the standard treatment. But in school-age children this clinical benefit could not be demonstrated by adding montelukast to the standard treatment of acute asthma in emergency room. Moreover in preschool children there are no studies on this topic.
The investigators hypothesized that addition of single dose of oral montelukast to standard therapy in acute moderate to severe wheezing may provide additional benefit in the meaning of improvement of pulmonary score and/or proportion of discharge from emergency department in preschool-age children.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •6 months to 6 years of age
- •With at least three episodes of wheezing in the previous 12 months
- •Who presented to the ED with a moderate to severe wheezing episode (defined as a Pulmonary Index Score [PIS] of 7 to 13
排除标准
- •Patients who were receiving more than 400 mcg of inhaled budesonide or equivalent per day
- •Who had any change in their dose of ICSs in the past 2 months
- •Who had taken systemic corticosteroid within 1 months
- •Patients who have concurrent pneumonia, croup or suspected foreign body aspiration, a history of cystic fibrosis, bronchopulmonary dysplasia, bronchiolitis obliterans, congenital heart disease, liver or renal disease,sickle cell anemia or immune deficiency were excluded.
研究组 & 干预措施
1-Montelukast
Children had received single dose of 4 mg oral montelukast after first dose of nebulized salbutamol and systemic glucocorticoids.
干预措施: montelukast 4 mg granule (Drug)
2- Placebo
Children had received single dose of oral placebo montelukast granule after first dose of nebulized salbutamol and systemic glucocorticoids.
干预措施: Montelukast placebo granüle (Drug)
结局指标
主要结局
Difference of pulmonary index score from baseline to 120 minutes.
时间窗: 0 to 120 minutes
İmprovment of pulmonary index score from 0 to 120 minutes was compared bwtween the montelukast and placebo groups.
次要结局
- Proportion of discharge from emergency department.(120, 180 and 240. minutes)
研究者
Cem Hasan Razi
MD
Kecioren Education and Training Hospital