A Randomized, Double-Blind, Multi-Center, Parallel-Group Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 on COPD Exacerbations Over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD (Ethos)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 8,588
- 试验地点
- 1
- 主要终点
- Adjusted Rate of Moderate or Severe Exacerbations
研究概览
简要总结
This is a randomized, double-blind, multi-center, parallel-group study to assess the efficacy and safety of PT010 relative to PT003 and PT009 on COPD exacerbations subjects with moderate to very severe COPD.
详细描述
A randomized, double-blind, multi-center, parallel-group study to assess the efficacy and safety of PT010 relative to PT003 and PT009 on COPD exacerbations over a 52-week treatment period in subjects with moderate to very severe COPD.
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 (PT010) MDI 320/14.4/9.6 μg
BGF MDI 320/14.4/9.6 μg, Budesonide, Glycopyrronium, Formoterol Fumarate Aerosol (PT010, BGF metered dose inhaler [MDI])
干预措施: BGF MDI 320/14.4/9.6 μg (Drug)
BGF (PT010) MDI 160/14.4/9.6 μg
BGF MDI 160/14.4/9.6 μg, Budesonide, Glycopyrronium, Formoterol Fumarate Aerosol (PT010, BGF metered dose inhaler [MDI])
干预措施: BGF MDI 160/14.4/9.6 μg (Drug)
BFF (PT009) MDI 320/9.6 μg
BFF MDI 320/9.6 μg Budesonide, Formoterol Fumarate Aerosol Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT009)
干预措施: BFF MDI 320/9.6 μg (Drug)
GFF (PT003) MDI 14.4/9.6 μg
GFF MDI 14.4/9.6 μg Glycopyrronium, Formoterol Fumarate Aerosol Budesonide and Formoterol Fumarate Inhalation Aerosol (PT003)
干预措施: GFF MDI 14.4/9.6 μg (Drug)
结局指标
主要结局
Adjusted Rate of Moderate or Severe Exacerbations
时间窗: 52-week treatment period
Adjusted Rate of Moderate or Severe Exacerbations
次要结局
- Time to First Moderate or Severe COPD Exacerbation(52 Weeks)
- Time to Death (All Cause)(52 Weeks)
- Change From Baseline in Average Daily Rescue Ventolin HFA Use Over 24 Weeks(24 Weeks)
- Percentage of Subjects Achieving a MCID of 4 Units or More in SGRQ Total Score(at Week 24)
- Rate of Severe COPD Exacerbations(52 Weeks)