NCT00463866已完成4 期
Local Phase 4 Pan-European SMART Study
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 8,424
- 试验地点
- 817
- 主要终点
- Number of Severe Asthma Exacerbations Per Participant.
研究概览
简要总结
The purpose of this study is to evaluate the effect of two different maintenance doses of Symbicort Maintenance And Reliever Therapy (SMART) in adult asthmatic patients. A 6 month treatment period
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
- •Patients at out-patient clinics
- •>18 years with a minimum of 6 months documented history of persistent asthma who have used inhaled glucocorticosteroids for at least one month and have a history of use in rapid-acting B2 agonists for symptom relief
排除标准
- •Asthma exacerbation within the last 14 days prior to study start
- •subject aged >40 years with a smoking history of >10pack-years
- •subjects with chronic obstructive lung disease or other significant respiratory disease
结局指标
主要结局
Number of Severe Asthma Exacerbations Per Participant.
时间窗: 6 months
Time to first severe asthma exacerbation, translated to mean number of severe asthma exacerbations per participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.
次要结局
- Fraction of Participants With Severe Asthma Exacerbation(6 months.)
- Total Number of Days Per Participant With Oral/Systemic Glucocorticosteroids During Severe Asthma Exacerbation(6 months.)
- Mean Daily Number of Inhalations of As-needed Medication.(4 weeks)
- Total Number of Severe Asthma Exacerbations That Led to Hospitalisation and/or Emergency Room Treatment.(6 months.)
- Percent of Participants With a Well Controlled Asthma Week.(6 months.)
- Mean Overall Asthma Control Questionnaire (ACQ) Score(6 months.)
- The Mean Total Daily Dose of Steroids From Symbicort.(4 weeks)
- Mean Cost Per Participant Per Country(6 months)
研究者
研究点 (817)
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