NCT00290264已完成3 期
A Comparison of Symbicort Single Inhaler Therapy (Symbicort Turbohaler 160/4.5 μg, 1 Inhalation b.i.d. Plus as Needed) and Conventional Best Practice for the Treatment of Persistent Asthma in Adolescents and Adults - a 26-week, Randomised, Open-label, Parallel-group, Multi-centre Study (SALTO)
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
- 209
- 主要终点
- Time to first severe asthma exacerbation
研究概览
简要总结
The primary objective is to compare the efficacy of Symbicort Single inhaler Therapy with treatment according to conventional best practice in adolescent and adult 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
- •Minimum of 3 months documented history of asthma, diagnosed according to the American Thoracic Society (ATS) definition.
- •Prescribed inhaled GCS at a dose of ≥320 µg/day and within the approved label for the relevant drug during the last 3 months prior to Visit 1.
排除标准
- •Use of any b-blocking agent, including eye-drops.
- •Use of oral GCS as maintenance treatment.
- •Known or suspected hypersensitivity to study therapy or excipients.
- •A history of smoking ≥ 10 pack years (1 pack year = 1 pack (20 cigarettes) per day for one year or equivalent).
结局指标
主要结局
Time to first severe asthma exacerbation
次要结局
- Number of severe asthma exacerbations
- Mean use of as-needed medication
- Prescribed asthma medication
- Peak Expiratory Flow (PEF)
研究者
研究点 (209)
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进行中（未招募）
不适用
A comparison 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-week, randomised, open-label, parallel-group, multicentre study - STYLEThis is a Phase IIIB trial to be conducted in patients with persistent asthmaMedDRA version: 7.0Level: LLTClassification code 10003553EUCTR2005-000532-25-LTAstraZeneca AB1,000