NCT00419952已完成3 期
A 52-week, Randomised, Double-blind, Parallel-group, Multi-centre, Phase IIIB Study Comparing the Long Term Safety of SYMBICORT® pMDI 160/4.5 mg x 2 Actuations Twice Daily to Budesonide HFA pMDI 160 mg x 2 Actuations Twice Daily in Adult/Adolescent (≥12 Years) African American Subjects With Asthma
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
- 742
- 试验地点
- 1
- 主要终点
- Total Number of Asthma Exacerbations
研究概览
简要总结
The purpose of this study is to determine the effectiveness and safety of SYMBICORT® pMDI (a medication approved by the Food and Drug Administration, FDA) in the African American population.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or Female, African American (self-reported), ≥12 years of age
- •Moderate to severe asthma requiring treatment with an inhaled corticosteroid
- •Diagnosis of asthma for at least 6 months
排除标准
- •Subjects requiring treatment with systemic corticosteroids (e.g., oral, parenteral, ocular)
- •Any significant disease or disorder that may jeopardize a subject's safety
研究组 & 干预措施
Symbicort
Experimental
Symbicort pMDI 160/4.5 ug x 2 actuations twice daily (BID)
干预措施: Budesonide/formoterol (SYMBICORT) pMDI (Drug)
Budesonide
Experimental
Budesonide HFA pMDI 160 ug x 2 actuations BID
干预措施: Budesonide HFA pMDI (Drug)
结局指标
主要结局
Total Number of Asthma Exacerbations
时间窗: 52 Weeks
An exacerbation was defined as symptomatic worsening requiring oral/systemic glucocorticoid therapy and/or emergency room visit and/or urgent care center visit and/or hospitalization.
次要结局
- Asthma Exacerbations(52 Weeks)
- QT Interval Corrected Using the Fridericia Formula Measured Via Electrocardiogram (ECG)(Baseline and 52 weeks)
- Number of Patients With Shift From Normal to High Rate of Total Ectopic Ventricular Beats as Measured by 24-hour Holter Monitor Assessment(Baseline and 2 weeks (visit 4))
- Number of Patients With Shift From Normal to High Rate of Total Ectopic Supraventricular Beats as Measured by 24-hour Holter Monitor Assessment(Baseline and 2 weeks (visit 4))
- Total Number of Ventricular Runs as Measured by 24-hour Holter Monitor Assessment(Baseline and 2 weeks (visit 4))
- Diary Assessments - Rescue-free Day(baseline and 52 weeks)
- Diary Assessments - Symptom-free Day(baseline and 52 weeks)
- Diary Assessments - Asthma-control Day(baseline and 52 weeks)
- Onset of Effect Questionnaire (OEQ)(1 week)
- Peak Expiratory Flow (PEF) in Morning(baseline and 52 weeks)
- Forced Expiratory Volume in One Second (FEV1)(baseline and 52 weeks)
- Asthma Treatment Satisfaction Measure (ATSM)(Baseline and 52 weeks)
研究者
研究点 (1)
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