NCT00163436已完成3 期
Comparison of the Efficacy and Safety of 160 mcg Ciclesonide Administered Once Daily in the Evening With or Without Different Spacer Types 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
- 450
- 试验地点
- 66
- 主要终点
- FEV1.
研究概览
简要总结
The aim of the present study is to investigate the efficacy and safety of ciclesonide on lung function and safety. Ciclesonide will be inhaled at one dose level once daily, using an inhaler device with or without spacer. The study duration consists of a baseline period (1 to 3 weeks) and a treatment period (12 weeks).
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
- None
入排标准
- 年龄范围
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main Inclusion Criteria:
- •Written informed consent
- •History of persistent bronchial asthma for at least 6 months
- •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
- •Smoking history with ≥10 cigarette pack years
- •Pregnancy
- •Intention to become pregnant
- •Breast feeding
- •Lack of safe contraception
- •Previous enrolment into the current study
结局指标
主要结局
FEV1.
次要结局
- physical examination
- vital signs
- morning and evening PEF from diaries
- asthma symptom score
- use of rescue medication
- percentage of nocturnal awakening-free days
- percentage of rescue medication-free days
- adverse events
- time to the first asthma exacerbation
- FVC
- number of patients with an asthma exacerbation
- percentage of days on which patient perceived asthma control
- percentage of asthma symptom-free days
- standard laboratory work-up
- 8 am serum cortisol.
研究者
研究点 (66)
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