A Comparison of Symbicort® SMART (160/4.5μg) and Symbicort® Turbuhaler 160/4.5 μg, Plus Terbutaline Turbuhaler 0.4 mg as Needed, for Treatment of Asthma - a 12-month, Randomized, Double-blind, Parallel Group, Active-controlled, Multinational Phase III Study in Asthmatic Patients From 16 Years
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 2,091
- 试验地点
- 1
- 主要终点
- The Percentage of Participants Who Had Experienced Asthma Exacerbation(s) at the End of the Study
研究概览
简要总结
The primary objective of this study is to compare the efficacy of Symbicort SMART (Symbicort Turbuhaler 160/4.5μg, one inhalation twice daily plus as needed) with Symbicort Turbuhaler 160/4.5μg, one inhalation twice daily plus terbutaline Turbuhaler 0.4 mg as needed, as asthma therapy
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of asthma according to the Global Initiative for Asthma guidelines (GINA) 2007 with a documented history of at least 6 months duration.
- •Reversible airway obstruction, defined as an increase in FEV1 ≥12% relative to baseline for all patients 15-30 minutes after inhalation of in total 2 x 0.4 mg terbutaline Turbuhaler
- •Prescribed use of inhaled glucocorticoid steroid (GCS) (any brand) for at least 12 weeks.
排除标准
- •Respiratory infection affecting the asthma, as judged by the investigator, within 4 weeks.
- •Intake of oral, rectal or parenteral GCS within 4 weeks and/or depot parenteral GCS within 12 weeks.
研究组 & 干预措施
1
Symbicort Turbuhaler 160/4.5 µg one inhalation bid (twice daily) + Symbicort Turbuhaler 160/4.5 µg as needed
干预措施: Symbicort Turbuhaler (Drug)
2
Symbicort Turbuhaler 160/4.5 µg one inhalation bid (twice daily) + terbutaline Turbuhaler 0.4 mg as needed
干预措施: Symbicort Turbuhaler (Drug)
2
Symbicort Turbuhaler 160/4.5 µg one inhalation bid (twice daily) + terbutaline Turbuhaler 0.4 mg as needed
干预措施: Terbutaline Turbuhaler (Drug)
结局指标
主要结局
The Percentage of Participants Who Had Experienced Asthma Exacerbation(s) at the End of the Study
时间窗: week 52
Asthma exacerbation was defined as deterioration in asthma leading to oral glucocorticosteroid \[GCS\] treatment, hospitalization, or emergency room \[ER\] treatment.
次要结局
- Morning Peak Expiratory Flow (PEF)(52-week treatment period)
- Forced Expiratory Volume in One Second (FEV1)(4, 12, 24, 36 and 52 weeks after randomization)
- Nights With Awakening(s) Due to Asthma Symptoms(52-week treatment period)
- Number of Asthma Exacerbations(up to 52 weeks)
- Symptom-free Days (no Symptoms and no Awakenings)(52-week treatment period)
- Percentage of Asthma-control Days (no Asthma Symptoms, no Awakenings, and no As-needed Use)(52-week treatment period)
- Asthma Control Questionnaire (ACQ)(4, 12, 24, 36 and 52 weeks after randomization)
- Evening PEF(2-week run-in period (14 - 18 days before randomization - week 0) and a 52-week treatment period)
- Use of As-needed Medication(52-week treatment period)
- The Percentage of Participants Who Had Experienced First Mild Asthma Exacerbations(up to 52 weeks)
- Percentage of As-needed-free Days(52-week treatment period)
- Asthma Symptom Score(52-week treatment period)