A Multicentre, Randomised, Double-blind, Parallel Group Study to Compare the Efficacy and Safety of Salmeterol/Fluticasone Propionate Combination Product (Seretide®) 50/100 mcg With Fluticasone Propionate (Flixotide® ) 200 mcg, Both Delivered Twice Daily Via the DISKUS Inhaler, in the Treatment of Children Aged 6-12 Years With Symptomatic Asthma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Percentage of Symptom-free Days During the Last 10 Weeks of the Treatment Period
研究概览
简要总结
This study is being conducted to investigate whether in childhood salmeterol/ fluticasone propionate 50/100 bd delivered via the Diskus® inhaler and fluticasone propionate 200 mcg bd delivered via the Diskus® inhaler are non- inferior in terms of symptom control. Additionally we aim to show that salmeterol/ fluticasone propionate 50/100 bd is at least as good in terms of lung function improvement and bronchial hyperreactivity and enables a steroid-sparing management of asthma in children.
详细描述
A multicentre, randomised, double blind, parallel group study to compare the efficacy and safety of Salmeterol/Fluticasone propionate combination product (Seretide®) 50/100mcg with Fluticasone propionate (Flixotide®) 200mcg, both delivered twice daily via the DISKUS inhaler, in the treatment of children aged 6-12 years with symptomatic asthma.
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
- 6 Years 至 12 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
Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg
Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg
干预措施: Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg (Drug)
fluticasone propionate 2 x 100 mcg
fluticasone propionate 2 x 100 mcg
干预措施: fluticasone propionate 2 x 100 mcg (Drug)
结局指标
主要结局
Percentage of Symptom-free Days During the Last 10 Weeks of the Treatment Period
时间窗: Last 10 weeks of the treatment period (Weeks 16-26)
Asthma symptom-free days are defined as days (24 hour period) with no symptoms, as recorded in the participant's diary.
次要结局
- Percentage of Symptom-free Days During the Entire Treatment Period(Baseline to Week 26)
- Daily FEV1 and PEF Via the Electronic Peak Flow/FEV1 Meter (PIKO-1)(26 weeks)
- Cumulative Number of Symptom-free Weeks Until the End of Treatment(26 weeks)
- Geometric Means of Nitric Oxide (NO) at Week 26(Baseline and Week 26)
- Number of Asthma Exacerbations Per Treatment Group at Week 26(Week 26)
- Mean Change From Baseline in Provocation Dose (PD20) Causing a 20% Fall in FEV1 at Week 26(Baseline and Week 26)
- Bronchial Hyperresponsiveness With PD20 AMP in Selected Centres(26 weeks)
- Mean Change From Baseline in Percentage Predicted Forced Expiratory Volume in One Second (FEV1) at Week 26(Baseline and Week 26)
- Mean Change From Baseline in Forced Vital Capacity (FVC) at Week 26(Baseline and Week 26)
- Mean Change From Baseline in Midexpiratory Flow (MEF 50) at Week 26(Baseline and Week 26)
- Percent Change From Baseline in RINT Measurements at Week 26(Baseline and Week 26)
- Weekly Percentage of Participants With 'Good Controlled Weeks' and 'Maximal Controlled Weeks'(26 weeks)
- Frequency of Asthma Exacerbations (Discriminated on Severity)(26 weeks)
- Time to Asthma Control, Defined as the Time to First 'Good Controlled Week' or 'Maximum Controlled Week'(26 weeks)