A Double Blind, Double Dummy, Randomised, Multicentre, Four Arm Parallel Group Study to Assess the Efficacy and Safety of FlutiForm® pMDI 250/10µg (2 Puffs Bid) vs Fluticasone pMDI 250µg (2 Puffs Bid) Plus Formoterol pMDI 12µg (2 Puffs Bid) Administered Concurrently in Adult Subjects With Severe Persistent, Reversible Asthma.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,667
- 主要终点
- Comparison of FEV1 (Forced expiratory volume in the first second) values.
研究概览
简要总结
The study compares the efficacy and safety of FlutiForm® vs Flixotide® plus Foradil® in the treatment of severe persisent asthma in adult subjects.
详细描述
This is a study involving a 2 week run-in phase followed by an 8 week double blind treatment phase. During the run-in phase, subjects receive Flixotide®. In the treatment phase subjects will be randomised to one of the four treatment groups and will receive either high dose FlutiForm® and Foradil® plus Flixotide® placebo or low dose FlutiForm® plus Foradil® and Flixotide® placebo or Foradil® plus Flixotide® and FlutiForm® placebo or Flixotide® and FlutiForm® plus Foradil® placebo. Efficacy will be assessed by lung function tests, asthma symptoms, sleep disturbance due to asthma and rescue medication use. Safety will be assessed by adverse events, lab tests, ECGs and vital signs.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —(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 250/10 micrograms
Flutiform 250/10 micrograms (2 puffs bd)
干预措施: Flutiform 250/10 micrograms (Drug)
Flutiform 50/5 micrograms
Flutiform 50/5 micrograms (2 puffs bd)
干预措施: Flutiform 50/5 micrograms (Drug)
Flixotide pMDI 250 mcg + foradil pMDI 24 micrograms
Flixotide pMDI 250 mcg (2 puffs bd) + foradil pMDI 24 50/5 mcg (bd)
干预措施: Flixotide pMDI 250 mcg + foradil pMDI 24 micrograms (Drug)
Flixotide pMDI 250 micrograms
Flixatide pMDI 250 micrograms (2 puffs bd)
干预措施: Flixotide pMDI 250 micrograms (Drug)
结局指标
主要结局
Comparison of FEV1 (Forced expiratory volume in the first second) values.
时间窗: 8 weeks
8 weeks on treatment
次要结局
- Other lung function parameters, asthma symptom scores, sleep disturbance due to asthma, rescue medication use, AQLQ, safety assessments.(8 weeks)
