NCT00244608已完成3 期
A Comparison of the Inflammatory Control of Asthma Provided by One Inhalation of Symbicort® Turbuhaler® 160/4.5 µg/Inhalation b.i.d. Plus As-needed Versus One Inhalation of Symbicort® Turbuhaler® 320/9 µg/Inhalation b.i.d. + One Inhalation of Pulmicort® Turbuhaler® 400 µg/Dose b.i.d. Plus Terbutaline Turbuhaler® 0.4 mg/Inhalation As-needed. A 12-month, Randomised, Double-blind, Parallel-group, Active Controlled, Multinational, Phase IIIB Study in Adult Patients With Asthma, EOS
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
- 100
- 试验地点
- 22
- 主要终点
- Change in eosinophils in bronchial biopsies (first and last visit) and in sputum (5 times during the 12-month treatment period)
研究概览
简要总结
The purpose of this study is to determine if a flexible dose of Symbicort has a similar effect on the airways of patients with asthma as a higher fixed-dose of Symbicort with additional glucocorticosteroids added.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of asthma for at least 6 months
- •Prescribed daily use of glucocorticosteroids for at least 3 months prior to visit one
排除标准
- •Respiratory infection affecting asthma within 30 days prior to study
- •Intake of oral, rectal, or parenteral glucocorticosteroids within 30 days prior to study
- •Any significant disease or disorder that may jeopardize the safety of the patient
结局指标
主要结局
Change in eosinophils in bronchial biopsies (first and last visit) and in sputum (5 times during the 12-month treatment period)
次要结局
- Immunopathology and remodeling in biopsies
- Immunopathology and mediators in induced sputum
- Severe asthma exacerbations (number of and time to first)
- Forced expiratory volume in 1 second (FEV1)
- As-needed use
- Safety variables, including adverse events and vital signs
- All variables assessed over the 12-month treatment period
研究者
研究点 (22)
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