Phase 4 Cost-effectiveness Study of Beclomethasone Versus Ciclesonide as Controller Medications in Pediatric Asthma in a Hospital in Bogotá
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Effectiveness measured as number of patients free of asthmatic crisis with each molecule during the study period
研究概览
简要总结
The Objective was to Develop a Cost-Effectiveness study that compares Ciclesonide and Beclomethasone in pediatric asthma control.
详细描述
Cost-effectiveness study, of cohorts, observational, analytic, prospective, from health institution perspective. Based on published data related to percentage of patients free of crisis for both molecules, it was estimated that the sample size to detect significant differences between the two alternatives was 20 patients per alternative. Medical records of 94 patients with diagnosis of uncontrolled asthma were included, aged between 6 and 15 years, 47 received Beclomethasone randomly, and 47 received Ciclesonide randomly, treatment physician was blind related to this assignation, both cohorts were followed for 6 months, and primary effectiveness variable was defined as number of patients free of crisis with each alternative. Cost generating variables were defined as medication use, and hospital stay. Decision analysis was based on a decision tree.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 15 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with uncontrolled asthma diagnosis
- •Patients with only one controller medication
排除标准
- •Patients without lung infection
- •Patients without antibiotic use
研究组 & 干预措施
Ciclesonide
干预措施: Ciclesonide (Drug)
Beclomethasone
干预措施: Beclomethasone (Drug)
结局指标
主要结局
Effectiveness measured as number of patients free of asthmatic crisis with each molecule during the study period
时间窗: 6 months
Effectiveness was assesed counting number of patients that were free of asthmatic crisis for each steroid ciclesonide and beclomethasone during 6 months of treatment
次要结局
未报告次要终点
