A Long-term Study to Evaluate the Safety and Tolerability of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Japanese Subjects With Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 187
- 试验地点
- 1
- 主要终点
- Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Treatment Period
研究概览
简要总结
The primary purpose of the study is to evaluate the safety and tolerability of fluticasone furoate/GW642444 inhalation powder when administered once-daily for 52 weeks in Japanese patients with 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Out patient at least 40 years of age
- •Both genders; females childbearing potencial must be willing to use birth control method
- •A diagnosis of COPD at Screening
- •Subjects with a current or prior history of at least 10 pack-years of cigarett smoking at Screening
- •Post-bronchodilator FEV1/FVC ratio of less than 70%
- •Post-bronchodilator FEV1 of less than 80%
排除标准
- •Current diagnosis of sthma
- •Respiratory disorders other than COPD
- •Upper or lower respiratory infection, or exacerbation of COPD within 4 weeka prior to Screening
- •Concurrent other disease that would confound study participation or affect subject safety
- •Allergies to study drugs, study drugs' excipients, medications related to study drugs
- •Taking another investigational medication or medication prohibited for use during this study
研究组 & 干预措施
Fluticasone Furoate/GW642444 100/25mcg
Combination inhaled corticosteroid and long-acting beta2-agonist
干预措施: Fluticasone Furoate/GW642444 Inhalation Powder 100/25mcg (Drug)
Fluticasone Furoate/GW642444 200/25mcg
Combination inhaled corticosteroid and long-acting beta2-agonist
干预措施: Fluticasone Furoate/GW642444 Inhalation Powder 200/25mcg (Drug)
结局指标
主要结局
Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Treatment Period
时间窗: From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold \>=5%) and SAEs.
Number of Participants With Any Drug-related AE and Any Drug-related SAE Throughout the Treatment Period
时间窗: From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury. Relatedness was assessed by the investigator.
次要结局
- Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD)(Baseline (Week -2), Week 52/Withdrawal (WD))
- Change From Baseline in Heart Rate (HR) at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD(Baseline (Week 0), Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 52, Week 24/WD, Week 52/WD)
- Number of Participants With Pneumonia During the Treatment Period(From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD]))
- Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD)(Baseline (Week -2), and Week 52/Withdrawal (WD))
- Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD)(Baseline (Week -2), and Week 52/Withdrawal (WD)
- Change From Baseline in 24-hour Urinary Cortisol Excretion at Weeks 24 and 52/Withdrawal (WD)(Baseline (Week 0), Week 24, and Week 52/Withdrawal (WD))
- Change From Baseline in Blood Pressure at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD(Baseline (Week 0), Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 52, Week 24/WD, and Week 52/WD)
- Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings(Baseline (Week -2), Week 12, Week 24, and Week 52)