NCT00163358已完成3 期
Efficacy of Ciclesonide and of a Fixed Combination With Fluticasone Propionate and Salmeterol Versus Placebo on Long-term Asthma Control
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
- 630
- 试验地点
- 112
- 主要终点
- number of poorly controlled asthma days.
研究概览
简要总结
The aim of the study is to compare the efficacy of ciclesonide versus fixed combination of fluticasone propionate/salmeterol versus placebo, on long-term asthma control in patients with mild persistent asthma. The study duration consists of a baseline period (2 weeks) and a treatment period (12 months). 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
- 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:
- •Clinical diagnosis of mild persistent asthma
- •Pre-treatment with SABAs only
- •FEV1 ≥80% predicted
- •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
- •COPD (chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in pulmonary function
- •Pregnancy
- •Intention to become pregnant during the course of the study
- •Breast feeding
- •Lack of safe contraception
- •Current smokers ≥10 pack-years and ex-smokers with ≥10 pack-years
结局指标
主要结局
number of poorly controlled asthma days.
time until the first severe asthma exacerbation occurs
次要结局
- adverse events.
- percentage of days with asthma control
- percentage of days with asthma symptoms
- number of inhalations of rescue medication
- proportion of patients with severe asthma exacerbations
- blood eosinophils
- percentage of nocturnal awakenings due to asthma
- asthma symptom score
- differences in morning PEF from diary
- differences in FEV1 and FVC from spirometry
- AQLQ(S)
- health economic data
- vital signs
- laboratory work-up
研究者
研究点 (112)
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