A Two-Week, Randomized, Modified-Blind, Double-Dummy, Parallel-Group Efficacy and Safety Study of Arformoterol Tartrate Inhalation Solution Twice-Daily, Tiotropium Once-Daily, and Arformoterol Tartrate Inhalation Solution Twice-Daily and Tiotropium Once Daily in Subjects With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 235
- 主要终点
- Time-normalized Area Under the Change From Study Baseline Curve for Forced Expiratory Volume in One Second (FEV1) Over 24 Hours (nAUC0-24B)
研究概览
简要总结
The purpose of this study is to evaluate and compare the efficacy of arformoterol twice a day and tiotropium once a day (dosed sequentially) versus tiotropium once a day alone in subjects with Chronic Obstructive Pulmonary Disease (COPD).
详细描述
This study is a multicenter, randomized, modified-blind, double-dummy two-week parallel-group efficacy and safety study of arformoterol tartrate inhalation solution twice daily, tiotropium inhalation powder once daily and arformoterol tartrate inhalation solution twice daily and tiotropium inhalation powder once daily (dosed sequentially) in subjects with COPD. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects must be at least 45 years old at the time of consent.
- •Subjects must have a pre-established primary clinical diagnosis of COPD.
- •Subjects must have a baseline FEV1 of ≤65% of predicted normal value at Visit
- •Subjects must have a FEV1 ≥ 0.70L at Visit 1.
排除标准
- •Subjects who do not have a FEV1/forced vital capacity (FVC) ratio of ≤70% at Visit
- •Subjects who do not have a ³15 pack-year smoking history and a baseline breathlessness severity grade of ³2 (Modified Medical Research Council [MMRC] Dyspnea Scale Score) at Visit 1.
研究组 & 干预措施
Arformoterol 15 mcg twice daily
Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
干预措施: Placebo (Drug)
Tiotropium 18 mcg once daily
Tiotropium 18 mcg once daily/Placebo Inhalation Solution
干预措施: Tiotropium (Drug)
Tiotropium 18 mcg once daily
Tiotropium 18 mcg once daily/Placebo Inhalation Solution
干预措施: Placebo (Drug)
Arformoterol /Tiotropium
Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
干预措施: Arformoterol and Tiotropium (Drug)
Arformoterol 15 mcg twice daily
Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
干预措施: Arformoterol Tartrate Inhalation Solution (Drug)
结局指标
主要结局
Time-normalized Area Under the Change From Study Baseline Curve for Forced Expiratory Volume in One Second (FEV1) Over 24 Hours (nAUC0-24B)
时间窗: 24 hours following two weeks of dosing.
次要结局
- Time-normalized Area From Study Baseline Curve for FEV1 Over 0-12 Hours (nAUC0-12B)(0-12 hours following two weeks of dosing)
- Time Normalized Area Under the Change From Study Baseline Curve for FEV1 Over 12-24 Hours (nAUC12-24B)(Following 2 weeks of dosing)
- Change in FEV1 From Study Baseline to the 24-hour Timepoint (Trough)(Following 2 weeks of dosing)
- Change in FEV1 From Study Baseline at Each Assessed Timepoint Post First Dose of Study Medication(2 weeks)
- Change in FEV1 Percent of Predicted From Study Baseline at Each Assessed Timepoint Post First Dose of Study Medication(2 weeks)
- Peak Change in FEV1 Over 12 Hours Post Dose From Study Baseline(2 weeks)
- Time to Onset in Participants Who Achieved a 10% Increase in FEV1 From Visit Predose After 2 Weeks(2 weeks)
- Time to Onset in Participants Who Achieved a 15% Increase in FEV1 From Visit Predose After 2 Weeks(2 weeks)
- Change in Inspiratory Capacity From Study Baseline to the 24 Hour Timepoint (Trough) Following 2 Weeks of Dosing(2 weeks)
- Change in Forced Vital Capacity (FVC) From Study Baseline at Each Assessed Post Dose Timepoint(2 Weeks)
- Levalbuterol Metered Dose Inhaler (MDI) (Rescue Medication) Use in Days Per Week(2 weeks)
- Levalbuterol Metered Dose Inhaler (MDI) Rescue Medication Use in Actuations Per Day(2 weeks)
- Transition Dyspnea Index (TDI) Focal Score(2 weeks)
- Number of Participants With a >= 1 Unit of Improvement in the TDI Focal Score(2 weeks)
- Percentage of Participants With a >=1 Unit Improvement in Transition Dysnea Index (TDI) Focal Score(2 weeks)