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临床试验/NCT01333800
NCT01333800已完成4 期

Phase 4 Cost-effectiveness Study of Beclomethasone Versus Ciclesonide as Controller Medications in Pediatric Asthma in a Hospital in Bogotá

Grünenthal Colombiana S.A.1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2010年7月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

干预措施: Ciclesonide (Drug)

Beclomethasone

Placebo Comparator

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

研究者

发起方
Grünenthal Colombiana S.A.
申办方类型
Industry

研究点 (1)

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