NCT00163332已完成3 期
Comparison of Inhaled Ciclesonide (160 mcg b.i.d. or 320 mcg b.i.d.) and Fluticasone Propionate (250 mcg b.i.d. or 500 mcg b.i.d.) in Pretreated Patients With Mild to Moderate 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
- 30
- 试验地点
- 5
- 主要终点
- 24 h urinary cortisol excretion adjusted for creatinine.
研究概览
简要总结
The aim of the study is to investigate the effect of ciclesonide versus fluticasone propionate versus placebo on airway hyperresponsiveness and on the hypothalamic-pituitary-adrenal axis (HPA axis). Treatment medication will be administered as follows: ciclesonide or fluticasone propionate will be inhaled twice daily, using one of the two dose levels. The study duration consists of a baseline period (4 to 6 weeks), five treatment periods (9 days each), and a washout period between treatments (4 to 12 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
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
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
- •Main Inclusion Criteria:
- •Patients who have had a history of bronchial asthma for at least 6 months
- •FEV1 >60% of predicted for at least 24 h
- •Patients who are hyperresponsive to methacholine and to AMP
- •Patients who are in good health with the exception of asthma
排除标准
- •Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
- •Patients suffering from COPD and/or other relevant lung diseases except asthma
- •Current smokers and ex-smokers both with ≥10 pack years
结局指标
主要结局
24 h urinary cortisol excretion adjusted for creatinine.
AUC(0-24h)/24 h of serum cortisol level
次要结局
- pharmacokinetics
- safety and tolerability.
- lung function (FEV1, FVC)
- 8 am measurement of bone formation markers
- PC20FEV1 to methacholine
- PC20FEV1 to AMP
研究者
研究点 (5)
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