NCT00163319已完成3 期
Comparison of Inhaled Ciclesonide (640 mcg/Day) and Fluticasone Propionate (1000 mcg/Day) in Patients With Moderate and Severe Persistent 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
- 500
- 试验地点
- 90
- 主要终点
- number of patients with candidiasis of the oropharynx or hoarseness.
研究概览
简要总结
The aim of the study is to compare the safety and efficacy of ciclesonide versus fluticasone propionate on the lung function, symptoms, use of rescue medication, and occurrence of side effects (such as candidiasis, hoarseness) in adults with persistent asthma. Ciclesonide will be inhaled twice daily at one dose level; fluticasone propionate will be inhaled twice daily at one dose level. The study duration consists of a baseline period (2 weeks) and a treatment period (24 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •History of bronchial asthma for at least 6 months
- •Pre-treatment with CFC-beclomethasone dipropionate (CFC-BDP) ≥ 1000 mcg/day or equivalent and a long-acting beta agonist (LABA) either in free or fixed combination
- •FEV1 ≥ 80% of predicted
排除标准
- •Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids or contraindications for the use of LABAs
- •Smoking with ≥10 pack-years
- •Pregnancy
- •Intention to become pregnant during the course of the study
- •Breast feeding
- •Lack of safe contraception
结局指标
主要结局
number of patients with candidiasis of the oropharynx or hoarseness.
次要结局
- proportion of cases of candidiasis of the oropharynx or
- percent of rescue medication free days
- asthma symptom score
- use of rescue medication
- AQLQ
- percent of nocturnal awakening-free days
- inhaled Corticosteroids Questionnaire (ICQ)
- percent days on which patient perceived asthma control
- percent symptom free days
- hoarseness at each visit Secondary variables
- diurnal PEF fluctuation
- number of patients with an asthma exacerbation
- physical examination, ECG
- skin bruising.
- FEV1, FVC, PEF from spirometry
- number of patients with candidiasis of the oropharynx or hoarseness by severity
- standard laboratory work-up
- morning serum cortisol
- morning and evening PEF from diaries
- onset of treatment effect
- time to first asthma exacerbation
- adverse events
- vital sings
研究者
研究点 (90)
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