NCT00314509已完成2 期
ADVICE: A Dose Range Finding Study of Formoterol Administered Once Daily in the Evening in Combination With Ciclesonide Using the Ultrahaler™ Versus Monotherapy of Each Drug in Asthmatic Patients
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 240
- 试验地点
- 26
- 主要终点
- Time to the first experience of lack of efficacy
研究概览
简要总结
The aim of the study is to compare the efficacy of two doses of a fixed combination of ciclesonide/formoterol fumarate versus ciclesonide alone versus formoterol fumarate alone in patients with asthma. The study duration consists of a baseline period (2 to 3 weeks) and a treatment period (8 weeks). The study will provide further data on safety and tolerability of ciclesonide/formoterol fumarate.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Good health with the exception of bronchial asthma (for at least 6 months)
- •FEV1 > 60% to < 80% of predicted (if pretreated with inhaled steroids only)
- •FEV1 > 60% to ≤ 85% of predicted (if pretreated with inhaled steroids in combination with other asthma controller)
排除标准
- •Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids or long-acting beta2-agonists
- •Chronic obstructive pulmonary disease (COPD), i.e. chronic bronchitis or emphysema, and/or other relevant lung diseases causing alternating impairment in pulmonary function
- •Current smoking or cessation of smoking within the last 6 months or previous smoking with a smoking history ≥ 10 cigarette pack-years
- •Use of other drugs not allowed
- •Pregnancy or intention to become pregnant during the course of the study, breast feeding, or lack of safe contraception in women of childbearing potential
结局指标
主要结局
Time to the first experience of lack of efficacy
AUC (FEV1) over a 24 h dosing interval.
次要结局
- FEV1
- proportion of patients with a clinical asthma exacerbation.
- morning and evening PEF, asthma symptoms and use of rescue medication
研究者
研究点 (26)
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