NCT00419757已完成3 期
A 12-week, Randomised, Double Blind, Active-controlled, Multi-centre, Phase IIIB Study Comparing the Efficacy and Safety of SYMBICORT® pMDI 160/4.5 mg x 2 Actuations Twice Daily Versus Budesonide HFA pMDI 160 mg x 2 Actuations Twice Daily, in Adult/Adolescent (> 12 Yrs) Hispanic 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
- 558
- 试验地点
- 1
- 主要终点
- Morning Peak Expiratory Flow (AM PEF)
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 Hispanic 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, Hispanic (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
Active Comparator
SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily
干预措施: Budesonide/formoterol (SYMBICORT) pMDI (Drug)
Budesonide
Active Comparator
budesonide HFA pMDI 160 μg x 2 actuations twice daily
干预措施: Budesonide HFA pMDI (Drug)
结局指标
主要结局
Morning Peak Expiratory Flow (AM PEF)
时间窗: Baseline (run-in) and throughout 12 weeks
Change from baseline (average of daily records over the 14 days of run-in) to the average of daily records over the treatment period of 12 weeks, with baseline value as covariate.
次要结局
- Percentage of Participants With Pre-defined Asthma Events(12 weeks)
- Percentage of Participants With "Withdrawals Due to Pre-defined Asthma Events"(12 weeks)
- Changes Pre-dose Forced Expiratory Volume in 1 Second (FEV1)(Baseline, 2, 6 and 12 weeks)
- Change From Baseline in a Evening Peak Expiratory Flow (PM PEF)(Baseline (run-in) and throughout 12 weeks)
- Change in Nighttime Asthma Symptom Score From Baseline Through 12 Weeks(Baseline (run-in) and throughout 12 weeks)
- Change in Daytime Asthma Symptom Score From Baseline Through 12 Weeks(Baseline (run-in) and throughout 12 weeks)
- Change in Asthma Related Awakenings Free Nights, From Baseline Through 12 Weeks(Baseline (run-in) and throughout 12 weeks)
- Change From Baseline in Rescue Medication Use Over 12 Weeks of Treatment(Baseline (run-in) and throughout 12 weeks)
- Change From Baseline in Rescue-free Days Over 12 Weeks of Treatment(Baseline (run-in) and throughout 12 weeks)
- Change From Baseline in Symptom-free Days Over 12 Weeks of Treatment(Baseline (run-in) and throughout 12 weeks)
- Subject Global Assessment(Baseline and week 12)
- Physician Global Assessment(Baseline and week 12)
- Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Control Relief Index(Week 12)
- Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Overall Perception of Medication(Week 12)
- Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Comparison With Other Medications(Week 12)
研究者
研究点 (1)
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