NCT00628758已完成3 期
A Comparison of Symbicort® Single Inhaler Therapy (Symbicort Turbuhaler® 160/4.5mg, 1 Inhalation Two Times a Day (b.i.d.) Plus as Needed) and Conventional Best Practice for the Treatment of Persistent Asthma in Adults a -26-week, Randomized, Open-label, Parallel-group, Multicentre Study
适应症
干预措施
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
- 430
- 试验地点
- 1
- 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 adult patients with persistent asthma.
详细描述
A secondary objective is to collect safety data for treatment wtih Symbicort Single inhaler Therapy in 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent form. If the patient cannot read and write, verbal consent from the patient is required.
- •Ability to read and write in Turkish
- •Female or male outpatients aged 18 years
- •Minimum of 3 months history of asthma, diagnosed according to the American Thoracic Society (ATS) definition
- •Prescribed inhaled glucocorticosteroid (GCS) at a dose of 320mg/day and within the approved label for the relevant drug during the last 3 months prior to Visit 1
- •Either: daily maintenance treatment with both inhaled GCS and long-acting b2-agonist (LABA) or daily treatment with inhaled GCS alone (i.e. without LABA); and a history of suboptimal asthma control the month prior to enrollment as judged by the investigator; and use of 3 Peak Expiratory Flow inhalations ofas needed medication for symptom relief during the last 7 days before enrollment
排除标准
- •Previous treatment with Symbicort Single inhaler Therapy
- •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
- •Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator
- •Any significant disease or disorder, which, in the opinion of the investigator, may put the patient at risk because of participating in the study
研究组 & 干预措施
Symbicort
Experimental
Symbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed)
干预措施: Symbicort TBH - Turbuhaler (Drug)
Conventional BP
Experimental
Conventional Best Practice for Treatment of Asthma
干预措施: beta-II-agonist, inhale steroid (Drug)
结局指标
主要结局
Time to First Severe Asthma Exacerbation
时间窗: 26 weeks
Time to severe exacerbation among patients
次要结局
- Number of Severe Asthma Exacerbations(26 weeks)
- Change in Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) Score(Baseline and 26 weeks)
- Mean Use of As-needed Medication Per Day During Treatment Period(Daily recording during the treatment period of 26 weeks)
研究者
研究点 (1)
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