NCT00250679已完成3 期
Multicenter, Double-Blind, Double-Dummy, Randomized, Active-Controlled, Parallel Group Long-Term Safety Study of 15 μg and 25 μg Arformoterol Tartrate Inhalation Solution BID in Subjects With Chronic Obstructive Pulmonary Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 443
- 主要终点
- Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations
研究概览
简要总结
To evaluate the long-term safety and monitor the long-term efficacy of arformoterol over a period of 6 months in subjects with chronic obstructive pulmonary disease (COPD).
详细描述
This is a double-blind, double-dummy, multicenter, randomized, active-controlled, parallel group, outpatient, safety study to evaluate the long term safety of arformoterol in the treatment of subjects with COPD. Study participation will be over approximately 6 months. 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, Outcomes Assessor)
入排标准
- 年龄范围
- 35 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 35 years old at the time of consent
- •Subjects must have a pre-established, documented primary clinical diagnosis of non-asthmatic COPD or are referred for diagnosis of non-asthmatic COPD
- •Subjects must have a >=15 pack-year smoking history and a baseline breathlessness severity grade of >=2 (Modified Medical Research Council [MMRC] Dyspnea Scale Score) at Visits 1 and 2
- •Female subjects <=65 years of age must have a negative serum pregnancy test, females of childbearing potential must be using an acceptable method of birth control
- •Subjects must be in general good health.
- •Key Exclusion criteria:
- •Subjects with a history of asthma, with the exception of asthma diagnosed in childhood
- •Subjects with a blood eosinophil count >5% of total white blood cell count
- •Subjects have had a febrile illness within 72 hours (3 days) before Screening Visit 1
- •Subjects with a chest x-ray that suggests a diagnosis other than COPD (e.g., diagnostic of pneumonia, other infection, atelectasis, or pneumothorax or other active/ongoing pulmonary conditions)
排除标准
- 未提供
研究组 & 干预措施
Formoterol 12 ųg 2x/day
Active Comparator
干预措施: Formoterol 12 ųg BID (Drug)
Formoterol 12 ųg 2x/day
Active Comparator
干预措施: Placebo (Drug)
Arformoterol 15 ųg 2x/day
Experimental
干预措施: Placebo (Drug)
Arformoterol 25 ųg 2x/day
Experimental
干预措施: Arformoterol 25 ųg BID (Drug)
Arformoterol 25 ųg 2x/day
Experimental
干预措施: Placebo (Drug)
Arformoterol 15 ųg 2x/day
Experimental
干预措施: Arformoterol tartrate inhalation solution (Drug)
结局指标
主要结局
Percent (%) of Participants With Adverse Events (AEs), in Particular COPD Exacerbations
时间窗: Six months
Percent of participants with the adverse event specified. SOC = system organ class.
次要结局
- Transitional (Relative Change in) Dyspnea Index(weeks 13, 26)
- 6-Minute Walk: Change From Baseline in the Distance Walked in 6 Minutes(Post-Dose weeks 0, 13, 26)
- 6-Hour Peak Changes From Baseline in Forced Expiratory Volume (FEV1)(weeks 0,3,13,26)
- Time-Normalized Area Under the Curve (nAUC) From 0 to 6 Hrs for Forced Expiratory Volume in One Second (FEV1) Changes From Baseline(weeks 0,3,13,26)
- Number of Participants With Potentially Clinically Significant Heart Rate(visit 6 (week 27))
- Number of Participants With New 24-Hour Holter Monitoring Alerts(Visit 6 (week 27))
- Number of Participants With Potentially Clinically Significant Glucose Evaluations(visit 6 (week 27))
- Number of Participants With Potentially Clinically Significant Potassium Evaluations(visit 6 (week 27))
- Ipratropium Bromide Metered Dose Inhaler (MDI) Usage: Days Used Per Week(Screening (day-14 to 0) and Treatment (week 0 - 26))
- Ipratropium Bromide Metered Dose Inhaler (MDI) Usage: Number of Actuations Per Day(Screening (day-14 to 0) and Treatment (week 0 - 26))
- Forced Expiratory Volume in One Second (FEV1) Changes From Baseline for 24 Hour Post Dose Timepoint (Trough)(weeks 0,3,13,26)
- Subject Global Evaluations Change From Baseline(weeks 13, 26)
- Modified Medical Research Council Dyspnea Questionaire(Baseline (visit 2), weeks 13, 26)
- Percent (%) of Participants With an Improved Transitional Dyspnea Index(visits 4 (week 13), visit 5 (week 26))
- Mean Values for the 6-Minute Walk Test: Distance Walked in Meters(Baseline (Visit 2), week 13, week 26)
- Mean Values for Investigator Global Evaluations(Baseline (Visit 2), Weeks 13, 26)
- Mean Values for St. George's Respiratory Questionnaire(Baseline (Visit 2), weeks 13, 26)
- Mean Values for Subject Global Evaluations(Baseline (Visit 2), weeks 13, 26)
- Mean Values for Forced Expiratory Volume in One Second (FEV1)(Baseline (Visit 2), weeks 3, 13, 26)
- Number of Participants With New 12-Lead Electrocardiogram (ECG) Alerts(visit 6 (week 27))
- Inspiratory Capacity Changes From Baseline(weeks 0,3,13,26)
- Racemic Albuterol or Levalbuterol Metered Dose Inhaler (MDI) Usage: Days Used Per Week(Screening (day-14 to 0) and Treatment (week 0 - 26))
- Racemic Albuterol or Levalbuterol Metered Dose Inhaler (MDI) Usage: Number of Actuations Per Day(Screening (day-14 to 0) and Treatment (week 0 - 26))
- Investigator Global Evaluations Change From Baseline(weeks 13, 26)
- BODE Index(Baseline (visit 2), weeks 13, 26)
- Mean Change From Baseline in St. George's Respiratory Questionnaire(weeks 13, 26)
- Number of Participants With a >=4 Unit Improvement on the St. George's Respiratory Questionnaire(Visit 4 (week 13) , Visit 5 (week 26))
- Number of Participants With an Improved Transitional Dyspnea Index(weeks 13, 26)
- Percent (%) of Participants With a >=4 Unit Improvement in the St. George's Respiratory Questionaire(visit 4 (week 13), visit 5 (week 26))
- Mean Values for Inspiratory Capacity(Baseline (Visit 2), Weeks 3, 13, 26)
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