Clinical Evaluation of GW815SF for Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema)" A Long-term Treatment Study of GW815SF50/500µg in Chronic Obstructive Pulmonary Disease -
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 5
- 主要终点
- Number of Participants With Any Adverse Events (AEs) and Serious AEs (SAEs)
研究概览
简要总结
This study evaluates the safety of medicine on COPD (Chronic Obstructive Pulmonary Disease). This study will last up to 56 weeks, and subjects will visit the clinic 16 times. Subjects will be given breathing tests, and will record their breathing symptoms daily on diary cards.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
结局指标
主要结局
Number of Participants With Any Adverse Events (AEs) and Serious AEs (SAEs)
时间窗: Up to Week 56
AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include adverse events that result in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
次要结局
- Mean Change From Baseline in Level of Plasma Cortisol 1(Baseline and Week 24 and 52)
- Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)(Baseline and up to Week 56)
- Mean Change From Baseline in Weight(Baseline and up to Week 56)
- Mean Change From Baseline in Forced Vital Capacity (FVC)(Baseline and up to Week 52)
- Mean Change From Baseline in Maximal Expiratory Flow Rate at 25% (V25) and 50% (V50) of Vital Capacity(Baseline and up to Week 52)
- Change From Baseline in Symptom Score With Respect to Breathlessness, Cough, Sputum and Nighttime Awakenings(Baseline and up to Week 52)
- Median Time of Observed Maximum Plasma Concentration (Tmax) of FP(Within one hour prior to dosing, 30, 45 minutes, 1, 2, 3, 4, 6, 8 and 12 hours)
- Median Tmax of Salmeterol(Within one hour prior to dosing, 5, 15, 30, 45 minutes, 1, 2, 3 and 4 hours)
- Number of Participants With Abnormal (Shift From Baseline) Urinalysis Parameters(Up to Week 56)
- Mean Level of Plasma Cortisol 2(Up to Week 56)
- Mean Change From Baseline in Bone Mineral Density (BMD)(Baseline and up to Week 56)
- Mean Change From Baseline in Percent of Days Without Use of Rescue Medication(Baseline and up to Week 52)
- Mean Area Under the Plasma Concentration-time Curve From Zero up to the Last Quantifiable Plasma Concentration [AUC (0-t)] of Salmeterol(Within one hour prior to dosing, 5, 15, 30, 45 minutes, 1, 2, 3 and 4 hours)
- Number of Participants With Abnormal (Outliers From the Normal Range) Hematology Parameters(Up to Week 56)
- Number of Participants With Abnormal (Clinically Significant) Electrocardiogram (ECG) Findings(Up to Week 56)
- Number of Participants With Abnormal (Clinically Significant) Ophthalmological Examinations Findings(Up to Week 56)
- Mean Change From Baseline in Peak Expiratory Flow (PEF)(Baseline and up to Week 52)
- Mean Cmax of Salmeterol(Within one hour prior to dosing, 5, 15, 30, 45 minutes, 1, 2, 3 and 4 hours)
- Mean Area Under the Plasma Concentration-time Curve Over a Dosing Interval [AUC(0-tau)] of FP(Within one hour prior to dosing, 30, 45 minutes, 1, 2, 3, 4, 6, 8 and 12 hours)
- Number of Participants With Abnormal (Outliers From the Normal Range) Clinical Chemistry Parameters(Up to Week 56)
- Mean Change From Baseline in Pulse Rate(Baseline and up to Week 56)
- Number of Participants With Abnormal Oropharyngeal Examination Findings(Up to Week 56)
- Mean Frequency of Moderate and Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations(Up to Week 56)
- Mean Observed Maximum Plasma Concentration (Cmax) of Fluticasone Propionate (FP)(Within one hour prior to dosing, 30, 45 minutes, 1, 2, 3, 4, 6, 8 and 12 hours)