NCT00252824已完成3 期
A Comparison of the Efficacy of Symbicort® Single Inhaler Therapy (Symbicort Turbuhaler® 160/4.5 mg 1 Inhalation b.i.d. Plus As-needed) and Conventional Best Practice for the Treatment of Persistent Asthma in Adolescents and Adults - a 26 Weeks, Randomised, Open-label, Parallel-group, Multicentre Study
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
- 1,000
- 试验地点
- 53
- 主要终点
- Time to first severe asthma exacerbation
研究概览
简要总结
The purpose of the study is to compare the efficacy of a flexible dose of Symbicort with conventional stepwise treatment according to asthma treatment guidelines in patients with persistent asthma
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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Diagnosis of asthma ³ 3 months
- •Prescribed daily use of glucocorticosteroids at a dose > 320 mcg/ day for at least 3 months prior to Visit 1
排除标准
- •Smoking history > 10 pack-years
- •Asthma exacerbation requiring change in asthma treatment during the last 14 days prior to inclusion
- •Any significant disease or disorder that my jeopardize the safety of the patient.
- •Additional inclusion and exclusion criteria will be evaluated by the investigator.
结局指标
主要结局
Time to first severe asthma exacerbation
次要结局
- Number of asthma exacerbations
- Mean use of as-needed medication
- Prescribed asthma medication
- Asthma Control Questionnaire
- Asthma related costs (direct asthma medication, direct non-medication costs and indirect costs)
- Safety: Serious Adverse Events and discontinuations due to adverse events
- All variables assessed over the 6 months treatment period
研究者
研究点 (53)
Loading locations...
相似试验
已完成
4 期
MONO: Symbicort® Single Inhaler Therapy and Conventional Best Standard Treatment for the Treatment of Persistent Asthma in Adolescents and AdultsAsthmaNCT00242411AstraZeneca1,900
已完成
3 期
SYMPHONIE - A Comparison of Symbicort Single Inhaler and Conventional Best Practice for the Treatment of Persistent Asthma in Adolescents and AdultsAsthmaNCT00259792AstraZeneca1,000
已完成
3 期
A Comparison of Symbicort® Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent AsthmaAsthmaNCT00628758AstraZeneca430
已完成
3 期
DESOLO - SiT Peri-Launch: A Comparison of Symbicort Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma in AdultsAsthmaNCT00252863AstraZeneca1,600
进行中（未招募）
不适用
A comparison of the efficacy of Symbicort Single inhaler Therapy (Symbicort Turbuhaler 160/4.5 microg, one inhalation twice a day plus as-needed) and conventional best standard treatment for the treatment of persistent asthma in adolescents and adults. A randomised, open, parallel-group, multicentre, 26 weeks study - MONOEUCTR2004-000679-32-FIAstraZeneca Oy1,900