NCT00461812终止4 期
A Single-Blind, Randomized, Positive-controlled Study to Compare Monotherapy With an Inhaled Corticosteroid (Mometasone) to Combination Therapy With an Inhaled Corticosteroid + a Long-Acting Bronchodilator (Advair) in Patients With Milder Persistent Asthma
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Efficacy as Assessed my Pulmonary Function Tests
研究概览
简要总结
The research hypothesis for the proposed study asks the question, can Asmanex® demonstrate comparable anti-inflammatory therapeutic efficacy to the combination product, Advair® in control of mild persistent asthma?
The purpose is to demonstrate that the anti-inflammatory protection afforded by monotherapy with an inhaled steroid (Asmanex®) is comparable to combination therapy with Advair® 100/50, when measured by this standard methodology (methacholine bronchoprovocation) in subjects with mild persistent 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
- Single
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects 18 to 65 years of age
- •a >2 year history of asthma
- •FEV1 > 80% for subjects currently using Advair®.
排除标准
- •severe asthma
- •current smokers
- •pregnant or breast-feeding women
- •other chronic significant illnesses
研究组 & 干预措施
Mometasone
Experimental
干预措施: Mometasone (Drug)
Advair
Experimental
干预措施: Advair (Drug)
结局指标
主要结局
Efficacy as Assessed my Pulmonary Function Tests
时间窗: change from baseline to study completion
次要结局
未报告次要终点
研究者
研究点 (1)
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