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临床试验/NCT00163332
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

AstraZeneca5 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2003年3月1日最近更新:
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

发起方
AstraZeneca
申办方类型
Industry
责任方
Sponsor

研究点 (5)

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