NCT00158834已完成3 期
Comparison of Stepwise Treatment of Asthmatic Children With Salmeterol/Fluticasone Propionate Combination Product (Seretide®) and/or Fluticasone Propionate (Flixotide®) Based on PD20 Methacholine and Symptoms or Based on Symptoms Only (Children Asthma Therapy Optimal)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 17
- 主要终点
- Asthma symptom free days during the last 12 weeks of the treatment period.
研究概览
简要总结
This study was designed to evaluate if, in children with asthma, a stepwise treatment (five levels varying from once daily fluticasone propionate 100mcg until twice daily a fixed combination of salmeterol and fluticasone propionate 50/500 mcg) based on symptom scores alone results in a sub-optimal treatment when compared to treatment based on cumulative symptom scores and bronchial hyperresponsiveness (PD20 methacholine).
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
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with a documented history of asthma.
- •Using inhaled steroids from 100 mcg up to 500 mcg twice daily for at least 1 month before study start.
- •Must be able to perform reproducible lung function tests.
- •Must have a positive RAST or skin prick test.
- •During the treatment period, the patient has to be hyperreactive (defined as PD20 methacholine < 150 mcg) and/or have a cumulative symptom score of 14 based on the daily record card filled in during the last 2 weeks of the run-in period.
排除标准
- •History of an acute upper or lower respiratory tract infection, middle ear, or sinus infection 4 weeks prior to visit
- •Admitted to hospital due to a respiratory disease 4 weeks prior to visit
- •Received oral corticosteroids within 4 weeks prior to visit
- •Existence of any disorder that affects growth.
- •Clinical or laboratory evidence of a serious systemic disease, or suspected hypersensitivity to corticosteroids, lactose or short/long acting B2-agonists.
结局指标
主要结局
Asthma symptom free days during the last 12 weeks of the treatment period.
次要结局
- Bronchial hyperresponsiveness, determined by PD20 methacholine at the end of the study.
研究者
研究点 (17)
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