NCT00096616已完成2 期
A Single Dose, Randomized, Double-blind Crossover Comparison of Combivent CFC MDI and Albuterol HFA MDI in Patients With Moderate to Severe Persistent Asthma and Persistent Symptoms Despite Treatment With Inhaled Corticosteroids
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 27
- 主要终点
- FEV1 area under the curve (AUC) 0 to 6 hours Peak FEV1
研究概览
简要总结
The purpose of this study is to demonstrate the superior bronchodilator efficacy of inhaled Combivent® CFC MDI vs. Albuterol HFA MDI in moderate to severe asthma patients.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient greater than or equal to 18 years of age,
- •non-smokers,
- •diagnosed with asthma, with an FEV1 less than or equal to 70 percent of predicted normal,
- •stable use of Beta agonist
- •daily use of inhaled steroids for one year
排除标准
- •Patients with other significant diseases other than asthma, requiring oxygen,
- •intubated within 5 years,
- •asthma exacerbation within 6 weeks of trial,
- •use of unstable doses (greater than 10 mg/day of prednisone or equivalent) of steroids,
- •participating in another interventional trial
结局指标
主要结局
FEV1 area under the curve (AUC) 0 to 6 hours Peak FEV1
次要结局
- FEV1 at each timepoint Peak FVC FVC at each timepoint FVC AUC 0-6 Adverse events Vital signs
研究者
研究点 (27)
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