NCT00163345已完成3 期
Evaluation of Parameters of the Small Airways and Their Changes Under Treatment With Ciclesonide (320 mcg Once Daily) Versus Placebo in Patients With Asthma
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- bronchial and alveolar exhaled NO
研究概览
简要总结
The aim of this study is to evaluate the involvement of small airways in asthma, as determined by bronchial challenges, CT-scanning, and cellular markers of inflammation. Ciclesonide will be inhaled at one dose level once daily. The study duration consists of a baseline period (2 to 3 weeks) and a treatment period (5 to 6 weeks). The study will provide further data on safety and tolerability of ciclesonide.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •History of bronchial asthma
- •FEV1 more than or equal to 60% of predicted
- •Stable asthma
- •Patients who are in good health with the exception of asthma
排除标准
- •Concomitant severe diseases, diseases expected to interfere with the outcome of the study, or diseases which are contraindications for the use of ICS
- •COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
- •Use of ICS 4 weeks before entry into the baseline period
- •Pregnancy
- •Intention to become pregnant during the course of the study
- •Breast feeding
- •Lack of safe contraception
- •Use of other drugs not allowed
- •Current smokers and ex-smokers with more than or equal to 10 pack-years
结局指标
主要结局
bronchial and alveolar exhaled NO
non-cellular inflammatory markers.
FVC% at PC20 AMP, SVC% at PC20 AMP
regional air trapping
variables of primary interest are FVC% at PC20 MCh, SVC% at PC20 MCh
lung function variables
次要结局
- safety and tolerability.
研究者
研究点 (2)
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