NCT00563056已完成3 期
Open, Randomised, Parallel Group Multicentre Study to Compare the Efficacy & Safety of Flutiform® pMDI vs Fluticasone pMDI Plus Formoterol DPI in Adolescent & Adult Subjects With Mild to Moderate-severe Persistent, Reversible Asthma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 227
- 试验地点
- 2
- 主要终点
- Comparison of mean Forced Expriatory Volume in the 1st second (FEV1) values.
研究概览
简要总结
Flutiform® compared with the individual components Flixotide® (Fluticasone) and Foradil® (Formoterol) in adolescent and adult patients.
详细描述
This is a study involving a 12 week treatment phase. During the treatment phase subjects receive Flutiform® or Flixotiole® and Foradil® as individual componements. Efficacy will be assessed by lung function tests and asthma symptoms, sleep disturbance. Safety will be assessed by adverse events, vital signs, lab tests and ECGs.
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
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Flutiform
Experimental
2 puffs 50/5 or 125/5 mcg
干预措施: Flutiform (Drug)
Flixotide plus Foradil
Active Comparator
Flixotide 2 puffs 50 or 125 mcg; Foradil 1 puff 12 mcg
干预措施: Flixotide plus Foradil (Drug)
结局指标
主要结局
Comparison of mean Forced Expriatory Volume in the 1st second (FEV1) values.
时间窗: 12 weeks
次要结局
- Discontinuation, PEFR, rescue medication use, asthma symptom scores, sleep disturbance, AQLQ, exacerbations, patient acceptance(12 weeks)
研究者
研究点 (2)
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