A Randomized, Double-Blind, Parallel-Group, 24-Week, Chronic-Dosing, Multi-Center Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort® Turbuhaler® as an Active Control in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,902
- 试验地点
- 1
- 主要终点
- FEV1 AUC0-4
研究概览
简要总结
Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort® Turbuhaler® in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease.
详细描述
A Randomized, Double-Blind, Parallel-Group, 24-Week, Chronic-Dosing, Multi-Center Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort® Turbuhaler® as an Active Control in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease
This study includes the following 3 sub-studies: 12-hour Pulmonary Function Test (PFT), Pharmacokinetic (PK) Profile, and Hypothalamic-pituitary-adrenal Axis.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BGF MDI (PT010) 320/14.4/9.6 μg ex-actuator
BGF MDI 320/14.4/9.6 μg,Budesonide, Glycopyrronium, Formoterol Fumarate Inhalation Aerosol
干预措施: BGF MDI 320/14.4/9.6 μg (Drug)
GFF MDI (PT003) 14.4/9.6 μg ex-actuator
GFF MDI 14.4/9.6 μg ex-actuator Glycopyrronium, Formoterol Fumarate Inhalation Aerosol
干预措施: GFF MDI (PT003) 14.4/9.6 μg (Drug)
BFF MDI (PT009) 320/9.6 μg ex-actuator
BFF MDI 320/9.6 μg, Budesonide, Formoterol Fumarate Inhalation Aerosol
干预措施: BFF MDI (PT009) 320/9.6 μg (Drug)
Symbicort
Symbicort® Turbuhaler® (TBH) Inhalation Powder 200/6 μg
干预措施: Symbicort® Turbuhaler® (TBH) Inhalation Powder (Drug)
结局指标
主要结局
FEV1 AUC0-4
时间窗: at Week 24
FEV1 AUC0-4 (L) for The Efficacy Estimand (Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 4 hours (AUC0-4) AUC was normalized for length of follow up (e.g. typically 4 hours)).
Change From Baseline in Morning Pre-dose Trough FEV1
时间窗: at Week 24
Morning Pre-Dose Trough FEV1 (L) for The Efficacy Estimand
次要结局
- Rate of Moderate or Severe COPD Exacerbations(over 24 weeks)
- Time to Onset of Action on Day 1, 5 Minutes Post Dose(Day 1)
- Peak Change From Baseline in FEV1 Within 4 Hours Post-dosing(at Week 24)
- Time to Onset of Action on Day 1, 2 Hours Post Dose(Day 1)
- Time to Onset of Action on Day 1, 4 Hours Post Dose(Day 1)
- Change From Baseline in Morning Pre-dose Trough FEV1(over 24 Weeks)
- Percentage of Subjects Achieving a Minimal Clinically Important Difference (MCID) of 4 Units or More in SGRQ Total Score (SGRQ Responders)(at Week 24)
- Change From Baseline in Average Daily Rescue Ventolin HFA Use(over 24 Weeks)
- Time to Onset of Action on Day 1, 15 Minutes Post Dose(Day 1)
- Time to Onset of Action on Day 1, 30 Minutes Post Dose(Day 1)
- Time to Onset of Action on Day 1, 1 Hour Post Dose(Day 1)