NCT00920959已完成3 期
A Stratified, Randomized, Double-blind, Placebo-controlled, Parallel-group, 12 Week Trial Evaluating the Safety and Efficacy of Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50mcg Once Daily Versus Fluticasone Propionate DISKUS 100mcg Once Daily and Placebo in Symptomatic Pediatric Subjects (4-11 Years) With 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
- 908
- 试验地点
- 1
- 主要终点
- Change from baseline at endpoint in daily PM PEF
研究概览
简要总结
To demonstrate if once-daily dosing of ADVAIR 100/50 once-daily has superior efficacy and comparable safety compared with FP 100mcg once-daily in pediatric subjects 4 to 11 years of age with 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
- 4 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Out-patients
- •Asthma diagnosis
- •Reversibility
- •Short-acting beta-agonist or asthma controlled medication use
排除标准
- •Life-threatening asthma
- •Specified asthma medications
- •Chickenpox
- •Drug allergy
- •Respiratory infections
- •Tobacco use
- •Clinical laboratory abnormalities
- •Ophthalmologic conditions
- •Investigation medications
- •Affiliation with investigator site
研究组 & 干预措施
Fluticasone propionate/salmeterol combination
Experimental
study drug
干预措施: FSC 100/50mcg (Drug)
Fluticasone propionate
Experimental
study drug
干预措施: FP 100mcg (Drug)
Placebo
Experimental
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline at endpoint in daily PM PEF
时间窗: 12 weeks
次要结局
- Various pulmonary function endpoints(12 weeks)
研究者
研究点 (1)
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