A 6-week, Phase III, Double-blind, Randomized, Multi-centre, Parallel-group Study Evaluating the Efficacy and Safety of 2 Actuations Symbicort®pMDI® 40/2.25 μg Twice Daily Compared With 1 Inhalation Symbicort Turbuhaler® 80/4.5 μg Twice Daily and 1 Inhalation Pulmicort®Turbuhaler® 100 μg Twice Daily
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
- Morning Peak Expiratory Flow (PEF)
研究概览
简要总结
The purpose of the this study is to evaluate the efficacy and safety of 2 actuations Symbicort®pMDI® 40/2.25 μg twice daily compared with1 inhalation Symbicort Turbuhaler® 80/4.5 μg twice daily and 1 inhalation Pulmicort®Turbuhaler® 100 μg twice daily for 6 weeks.
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
- •Asthma clinically diagnosed since at least 6 months.
- •Lung function values measured ≥ 50% and ≤ 90% of predicted normal.
- •Patients with reversible airway obstruction Daily use of inhaled steroids (any brand) for >3 months.
排除标准
- •Use of oral, rectal or parenteral steroids within 30 days prior to start of study.
- •Respiratory infection affecting the asthma, as judged by the investigator, within 30 days prior to start of randomised treatment.
- •Any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study or the patient's ability to participate in the study.
研究组 & 干预措施
Symbicort pMDI
Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
干预措施: Symbicort pMDI (Drug)
Symbicort Turbuhaler
Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
干预措施: Symbicort Turbuhaler (Drug)
Pulmicort Turbuhaler
Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
干预措施: Pulmicort Turbuhaler (Drug)
结局指标
主要结局
Morning Peak Expiratory Flow (PEF)
时间窗: Baseline to 6 weeks
Change in the Morning PEF from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomisation). No imputation of missing data was performed
次要结局
- Evening Peak Expiratory Flow (PEF)(Baseline to 6 weeks)
- Asthma Symptom Score, Night(Baseline to 6 weeks)
- Asthma Symptom Score, Day(Baseline to 6 weeks)
- Asthma Symptom Score, Total(Baseline to 6 weeks)
- Percentage of Nights With Awakenings Due to Asthma(Baseline and 6 weeks)
- Use of Rescue Medication, Night(Baseline to 6 weeks)
- Use of Rescue Medication, Day(Baseline to 6 weeks)
- Use of Rescue Medication, Total(Baseline to 6 weeks)
- Percentage of Symptom-free Days(Baseline to 6 weeks)
- Percentage of Asthma Control Days(Baseline to 6 weeks)
- Percentage of Rescue Free Days(Baseline to 6 weeks)
- Forced Expiratory Volume in 1 Second (FEV1)(Baseline to 6 weeks)