NCT00252785已完成3 期
An 8-week, Randomised, Double Blind, Parallel-group, Multi-centre, Phase III Study Comparing the Efficacy and Safety of Symbicort® Turbuhaler® 160/4.5 µg Twice Daily and Pulmicort® Turbuhaler® 200 µg Twice Daily + Theolong® Tablet 200 mg Twice Daily in Japanese 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
- 340
- 试验地点
- 43
- 主要终点
- Morning peak expiratory flow (mPEF)
研究概览
简要总结
The primary objective of this study is to confirm the efficacy (superiority) of Symbicort® Turbuhaler® 160/4.5 µg twice daily for 8 weeks in comparison to Pulmicort® Turbuhaler® 200 µg twice daily + Theolong® tablet 200 mg twice daily.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of asthma with a documented history of at least 6 months duration prior to Visit 1
- •Prescribed daily use of an IGCS for >=12 weeks prior to Visit
- •The dose of IGCS must be 400 to 800 µg/day of Pulmicort® Turbuhaler® or corresponding dose of IGCS. The prescribed dose of IGCS should be constant for at least 4 weeks prior to Visit 1
- •Prescribed daily use of sustained release theophylline for at least 8 weeks prior to Visit 1, or confirmed steady-state blood theophylline concentrations within the effective range (5-15 µg/mL) during 8 weeks prior to Visit
- •The prescribed dose of theophylline should be constant (400 mg/day) for at least 4 weeks prior to Visit 1
排除标准
- •Any significant disease or disorder that may jeopardize the safety of the patient
- •Respiratory infection, judged by the investigator(s) as an infection affecting the asthma, within 4 weeks prior to Visit 1
- •Treatment with oral, parenteral or rectal GCS within 4 weeks prior to Visit 1
- •Additional inclusion and exclusion criteria will be evaluated by the Investigator
结局指标
主要结局
Morning peak expiratory flow (mPEF)
次要结局
- Patient reported outcomes regarding disease status (incl. evening PEF), collected via diaries
- Forced expiratory volume in one second (FEV1)
- Safety:
- Adverse events (nature, incidence and severity)
- Haematology, clinical chemistry and urinalysis
- 12-lead ECGs, blood pressure, pulse rate
- - all variables assessed over the 8 week treatment period
研究者
研究点 (43)
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