A Randomized, Double-Blind, Parallel-Group, 52-Week, Chronic-Dosing, Multi-Center Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 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
- 627
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline in BMD of the Lumbar Spine
研究概览
简要总结
Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease
详细描述
A Randomized, Double-Blind, Parallel-Group, 52-Week, Chronic-Dosing, Multi-Center Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease
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
- Double (Participant, Investigator)
盲法说明
Double-Blind
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
- •Given their signed written informed consent to participate. Must have agreed to participate in and complete the lead-in Study PT010006.(NCT02497001)
排除标准
- •Severe osteoporosis Unable to achieve an acceptable DEXA scan Inability to achieve pupil dilation to at least 6 mm Subjects with an implanted artificial intraocular lens or are scheduled to undergo cataract surgery
研究组 & 干预措施
BGF MDI (PT010) 320/14.4/9.6 μg
Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) metered dose inhaler (MDI) (PT010, BGF MDI)
干预措施: BGF MDI 320/14.4/9.6 μg (Drug)
GFF MDI (PT003) 14.4/9.6 μg
Glycopyrronium and Formoterol Fumarate (GFF) metered dose inhaler (MDI) (PT003, GFF MDI)
干预措施: GFF MDI 14.4/9.6 μg (Drug)
BFF MDI (PT009) 320/9.6 μg
Budesonide and Formoterol Fumarate (BFF) metered dose inhaler (MDI) (PT009, BFF MDI)
干预措施: BFF MDI 320/9.6 μg (Drug)
结局指标
主要结局
Percent Change From Baseline in BMD of the Lumbar Spine
时间窗: at week 52
Percent change from baseline in BMD of the lumbar spine T-Score at Week 52.
Change From Baseline in the LOCS III (P) Score at Week 52
时间窗: at week 52
Change from baseline in the LOCS III (P) score (Severity of Posterior Subcapsular Cataract) at Week 52. P score is reported as a decimalized scale ranging from 0.1 (indicating a completely clear or colorless lens) to 5.9 (indicating complete opacification on the posterior capsule). A negative change in P score indicates an improvement and a positive change indicates a deterioration of LOCS III. A change in P score within 0.5 is an acceptable variation margin.
次要结局
未报告次要终点