A Randomized, Double-Blind, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,876
- 试验地点
- 1
- 主要终点
- Morning Pre-dose Trough FEV1
研究概览
简要总结
This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study with PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID.
详细描述
This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study. Subjects will undergo a 1- to 4-week Screening Period. Subjects who successfully complete the Screening Period will be randomized to one of the following three treatment groups: PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID. Following randomization, subjects will enter the Treatment Period and undergo additional treatment visits over 52 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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Give their signed written informed consent to participate
- •At least 40 years of age and no older than 80 years of age
- •COPD patients who are symptomatic
- •Must be receiving one or more inhaled bronchodilators as maintenance therapy
- •Must have a documented history of COPD exacerbations
排除标准
- •Current diagnosis of asthma
- •COPD due to α1-Antitrypsin Deficiency
- •Known active tuberculosis, lung cancer, cystic fibrosis, and significant bronchiectasis, Pulmonary resection or Lung Volume Reduction Surgery during the past 6 months.
- •Long-term-oxygen therapy (≥ 15 hours a day).
研究组 & 干预措施
BFF MDI (PT009) 320/9.6 μg
Budesonide and Formoterol Fumarate Inhalation Aerosol - 160/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
干预措施: BFF MDI (PT009) 320/9.6 μg (Drug)
BFF MDI (PT009) 160/9.6 μg
Budesonide and Formoterol Fumarate Inhalation Aerosol - 80/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
干预措施: BFF MDI (PT009) 160/9.6 μg (Drug)
FF MDI (PT005) 9.6 μg
Formoterol Fumarate Inhalation Aerosol - 4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
干预措施: FF MDI (PT005) 9.6 μg (Drug)
结局指标
主要结局
Morning Pre-dose Trough FEV1
时间窗: at Week 12
Morning pre-dose trough FEV1 (Forced Expiratory Volume in one second) at week 12
次要结局
- Time to First Moderate or Severe COPD Exacerbation(over 52 weeks)
- Change From Baseline in Average Daily Rescue Ventolin HFA Use(over 12 weeks)
- Percentage of Subjects Achieving an MCID (Minimal Clinically Important Difference) of 4 Units or More in Saint George's Respiratory Questionnaire (SGRQ) Total Score(at Week 12)