A 24-week Treatment, Multi-center, Randomized, Double-blind, Double-dummy, Parallel Group Study to Compare Umeclidinium/Vilanterol, Umeclidinium, and Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 2,696
- 试验地点
- 1
- 主要终点
- Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Week 24
研究概览
简要总结
COPD is characterized by an airflow limitation, which is not fully reversible, usually progressive and accompanied by chronic cough, sputum production and dyspnea, which can be a major cause of disability and anxiety associated with the disease. In addition, COPD is associated with poor health-related quality of life (HRQoL). Pharmacologic therapy is used to improve lung function, reduce symptoms, reduce the frequency and severity of exacerbations, and also to improve health status and exercise tolerance.
This is a multi-center, randomized, double blind, double dummy, 3-arm parallel group study to compare umeclidinium/vilanterol (62.5/25 microgram [mcg], once daily), umeclidinium (62.5 mcg, once daily), and salmeterol (50 mg, twice daily) in male and female subjects with COPD. The primary purpose of this study is to demonstrate improvements in lung function for subjects treated with UMEC/VI compared with UMEC for 24 weeks.
Approximately 2424 subjects will be randomized across 3 parallel arms in 1:1:1 ratio. Subjects will be stratified based on long-acting bronchodilator usage during the run-in period (none, one or 2 long-acting bronchodilators per day). Subjects will receive either UMEC/VI inhalation powder (62.5/25 microgram [mcg] once daily) administered via the ELLIPTA® dry powder inhaler (DPI) and placebo twice daily via DISKUS® DPI; or UMEC (62.5 mcg once daily) administered via the ELLIPTA DPI and placebo twice daily via DISKUS DPI or salmeterol (50 mcg twice daily [BID]) administered via the DISKUS DPI and placebo once daily via ELLIPTA DPI. The duration of the study will be 29 to 31 weeks including a pre-screening period of 2 weeks, run-in period of 4 weeks, treatment period of 24 weeks and follow-up period of 1 week.
ELLIPTA and DISKUS are trademarks of GSK group of companies.
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
- Triple (Participant, Care Provider, 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
UMEC/VI 62.5/25 mcg via ELLIPTA + placebo via DISKUS
Subjects will be instructed to self-administer one dose of UMEC/VI 62.5/25 mcg inhalation powder each morning via ELLIPTA DPI and placebo twice daily (morning and evening) via DISKUS DPI.
干预措施: UMEC/VI 62.5/25 mcg via ELLIPTA (Drug)
UMEC/VI 62.5/25 mcg via ELLIPTA + placebo via DISKUS
Subjects will be instructed to self-administer one dose of UMEC/VI 62.5/25 mcg inhalation powder each morning via ELLIPTA DPI and placebo twice daily (morning and evening) via DISKUS DPI.
干预措施: Placebo via DISKUS (Drug)
UMEC 62.5 mcg via ELLIPTA + placebo via DISKUS
Subjects will be instructed to self-administer one dose of UMEC 62.5 mcg inhalation powder each morning via ELLIPTA DPI and placebo twice daily (morning and evening) via DISKUS DPI.
干预措施: UMEC 62.5 mcg via ELLIPTA (Drug)
UMEC 62.5 mcg via ELLIPTA + placebo via DISKUS
Subjects will be instructed to self-administer one dose of UMEC 62.5 mcg inhalation powder each morning via ELLIPTA DPI and placebo twice daily (morning and evening) via DISKUS DPI.
干预措施: Placebo via DISKUS (Drug)
Salmeterol 50 mcg via DISKUS + placebo via ELLIPTA
Subjects will be instructed to self-administer one dose of salmeterol 50 mcg twice daily (morning and evening) via DISKUS DPI and placebo once daily morning via ELLIPTA DPI.
干预措施: Salmeterol 50 mcg via DISKUS (Drug)
Salmeterol 50 mcg via DISKUS + placebo via ELLIPTA
Subjects will be instructed to self-administer one dose of salmeterol 50 mcg twice daily (morning and evening) via DISKUS DPI and placebo once daily morning via ELLIPTA DPI.
干预措施: Placebo via ELLIPTA (Drug)
结局指标
主要结局
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Week 24
时间窗: Baseline (Pre-dose on Day 1) and Week 24
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 at Week 24 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on the previous day. Baseline trough FEV1 is the mean of the values measured at 30 minutes and 5 minutes pre-dose on Day 1. Change from Baseline was calculated as the trough FEV1 value on Week 24 minus the Baseline value. Analysis was performed using a repeated measures model (MMRM) with covariates of Baseline FEV1, geographical region, stratum (number of bronchodilators per day during run-in), visit, treatment, visit by Baseline and visit by treatment interaction. ITT population comprised of all randomized participants (excluding those who were randomized in error) who received at least one dose of study medication.
次要结局
- Self Administered Computerized (SAC) Transient Dyspnea Index (TDI) Focal Score at Week 24(Week 24)
- Percentage of TDI Responders According to SAC TDI Focal Score(Week 24)
- Mean Change From Baseline in Evaluating Respiratory Symptoms (E-RS) Total Score(Baseline (Pre-dose on Day 1) and Week 21 to Week 24)
- Mean Change From Baseline in E-RS Subscale Score(Baseline (Pre-dose on Day 1) and Week 21 to Week 24)
- Percentage of E-RS Responders According to E-RS Total Score(Week 21 to Week 24)
- Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score(Baseline (Pre-dose on Day 1) and Week 24)
- Percentage of Responders Based on the Saint (St) George Respiratory Questionnaire COPD Specific (SGRQ) Total Score(Week 24)
- Change From Baseline in COPD Assessment Test (CAT)(Baseline (Pre-dose on Day 1) and Week 24)
- Percentage of Responders According to CAT(Week 24)
- Number of Participants With on Treatment Adverse Events (AE) and Serious Adverse Events (SAE)(Up to Week 24)