A Study to Compare GW815SF HFA MDI With Concomitant Treatment With Salmeterol Xinafoate DPI Plus Fluticasone Propionate DPI and to Assess Long-term Safety of GW815SF HFA MDI
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Adjusted Mean Change From Baseline in Morning PEF (Peak Expiratory Flow) During the 4-week Treatment Periods
研究概览
简要总结
To evaluate the efficacy and safety of GW815SF HFA MDI 25/50µg 1 inhalation bid in comparison with concomitant treatment with salmeterol xinafoate DPI 25µg 1 inhalation bid plus fluticasone propionate DPI 50µg 1 inhalation bid in paediatric patients with asthma.
To evaluate the safety of long-term treatment of GW815SF HFA MDI 25/50µg 1 inhalation bid in paediatric patients with asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 14 Years（Child）
- 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
SLM+FP First
SLM(salmeterol) 25mcg + FP(fluticasone propionate) 50mcg twice daily in first intervention period and SFC(salmeterol/fluticasone propionate) 25/50mcg twice daily in second intervention period and (after washout period).
干预措施: GW815SF HFA MDI (Drug)
SLM+FP First
SLM(salmeterol) 25mcg + FP(fluticasone propionate) 50mcg twice daily in first intervention period and SFC(salmeterol/fluticasone propionate) 25/50mcg twice daily in second intervention period and (after washout period).
干预措施: salmeterol and fluticasone propionate (Drug)
SFC First
SFC (Salmeterol/Fluticasone propionate combination) 25/50mcg twice daily in first intervention period and SLM (Salmeterol) 25mcg + FP (Fluticasone Propionate) 50mcg twice daily in second intervention period (after washout period).
干预措施: GW815SF HFA MDI (Drug)
SFC First
SFC (Salmeterol/Fluticasone propionate combination) 25/50mcg twice daily in first intervention period and SLM (Salmeterol) 25mcg + FP (Fluticasone Propionate) 50mcg twice daily in second intervention period (after washout period).
干预措施: salmeterol and fluticasone propionate (Drug)
SFC
SFC (salmeterol/fluticasone propionate combination) 25/50mcg twice daily in Extension period (after cross-over period).
干预措施: GW815SF HFA MDI (Drug)
结局指标
主要结局
Adjusted Mean Change From Baseline in Morning PEF (Peak Expiratory Flow) During the 4-week Treatment Periods
时间窗: Crossover Period Weeks 1-4, and 7-10
Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period \[Weeks 1-4/Weeks 7-10\]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out (i.e., the last 7 days prior to the day of starting treatment period \[Weeks 1-4/Weeks 7-10\]).
次要结局
- Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 4-week Treatment Periods(Crossover Period Weeks 1-4, 7-10)
- Percentage of Subjects With Rescue Medication-Free Nights and Days(Crossover Period Weeks 1-4, 7-10)
- Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 4-week Treatment Periods(Crossover Period weeks 1-4, 7-10)
- Percentage of Subjects With Symptom-Free Nights & Days(Crossover Period Week 1-4, 7-10)
- Adjusted Mean Change From Baseline in Evening PEF During the 4-week Treatment Periods(Crossover Period weeks 1-4, 7-10)
- Adjusted Mean Change From Baseline of Circadian Variation in Morning PEF(%) During the 4-week Treatment Periods(Crossover Period Weeks 1-4, 7-10)
- Adjusted Mean Change From Baseline in Morning PEF During the 20-week Extension Treatment Period(Extension Period Weeks 11-30)
- Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 20-Week Extension Treatment Period(Extension Period weeks 11-30)
- Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 20-week Extension Treatment Period(Extension Period weeks 11-30)
- Adjusted Mean Change From Baseline in Evening PEF During the 20-week Extension Treatment Period(Extension Period weeks 11-30)
- Adjusted Mean Change From Baseline of Circadian Variation in PEF(%) During the 20-Week Extension Treatment Period(Extension Period weeks 11-30)
- Percentage of Subjects With Symptom-Free Nights & Days After 20 Weeks of Treatment(Extension Period Weeks 11-30)
- Percentage of Subjects With Rescue Medication-Free Nights & Days After 20 Weeks of Treatment(Extension Period Weeks 11-30)