A Phase 3, 12-Week, Double-Blind, Randomized, Parallel-Group, Multicenter Study Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg, 2 Actuations Twice Daily, and Symbicort pMDI 80/4.5 μg, 2 Actuations Twice Daily, Compared With Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in Children Ages 6 to <12 Years With Asthma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 882
- 试验地点
- 1
- 主要终点
- Change From Baseline to Week 12 in 1h Post-dose FEV1
研究概览
简要总结
The purpose is to investigate the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and Symbicort pMDI 80/4.5 μg, Compared with Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in Children Ages 6 to <12 Years with Asthma during 12 weeks.
详细描述
A Phase 3, 12-Week, Double-Blind, Randomized, Parallel-Group, Multicenter Study Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg, 2 Actuations Twice Daily, and Symbicort pMDI 80/4.5 μg, 2 Actuations Twice Daily, Compared with Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in Children Ages 6 to <12 Years with Asthma
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
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has a documented clinical diagnosis of asthma defined by the ATS for at least 6 months prior to Visit 2
- •Have a morning pre-bronchodilator clinic FEV1 measured at least 6 hours after the last dose of inhaled SABA and at least 48 hours after last dose of inhaled LABA of 60% to 100% of predicted normal
- •Demonstrated reversibility of clinic FEV1 of ≥12% from pre -albuterol/salbutamol level within 15 to 30 minutes after administration of a standard dose of albuterol/salbutamol.
排除标准
- •Have been hospitalized at least once or required emergency treatment more than once for an asthma-related condition during the 6 months prior to Visit 1
- •Have required treatment with systemic corticosteroids (eg, oral, parenteral, or rectal) for any reason within the 6 weeks prior to Visit 1
研究组 & 干预措施
Symbicort pMDI 80/2.25 µg
Budesonide/formoterol pMDI 80/2.25 µg, 2 acuations twice daily
干预措施: Symbicort pMDI (Drug)
Symbicort pMDI 80/4.5µg
Budesonide/formoterol pMDI 80/4.5µg, 2 acuations twice daily
干预措施: Symbicort pMDI (Drug)
Budesonide pMDI
Budesonide pMDI 80µg, 2 acuations twice daily
干预措施: Budesonide pMDI (Other)
结局指标
主要结局
Change From Baseline to Week 12 in 1h Post-dose FEV1
时间窗: Week 0 (baseline), Week 12
1h post-dose FEV1 is defined as the 1-hour post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).
次要结局
- Change From Baseline to Week 12 in 1h Post-dose FVC(Week 0 (baseline), Week 12)
- Change From Baseline to Week 12 in Pre-dose PEF(Week 0 (baseline), Week 12)
- Change From Baseline to Week 12 in 1h Post-dose PEF(Week 0 (baseline), Week 12)
- Change From Baseline to Week 12 in 1h Post-dose FEF25-75(Week 0 (baseline), Week 12)
- Change From Baseline to Week 12 in Pre-dose FEV1(Week 0 (baseline), Week 12)
- Change From Baseline to Week 12 in Pre-dose FEF25-75(Week 0 (baseline), Week 12)
- Change From Baseline to Week 12 in Pre-dose FVC(Week 0 (baseline), Week 12)
- Change From Baseline to Week 12 in 15 Min Post-dose FEV1(Week 0 (baseline), Week 12)
- Change From Baseline to End of Study Average in Total Asthma Symptoms(Week 0 (baseline), Week 12)
- Change From Baseline to End of Study Average in % of Night Time Awakenings Due to Asthma Symptoms(Week 0 (baseline), Week 12)
- Change From Baseline to End of Study Average in Total Daily Reliever Medication(Week 0 (baseline), Week 12)
- Change From Baseline to Study Period Average in Overall PAQLQ Score(Week 0 (baseline), week 4, week 8, week 12)
- Number of Patients With an Asthma Exacerbation During Study(Week 0 (baseline) up to Week 12)