Modified-blind, Randomized, Multicenter, Single Dose, Two-way Crossover Study of Arformoterol Tartrate Inhalation Solution 15 Micrograms Twice A Day Versus 30 Micrograms Once A Day 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
- 33
- 主要终点
- Time-Normalized Area Under the Change From Pre-Dose Curve for Forced Expiratory Volume in One Second Measured Over 24 Hours
研究概览
简要总结
To evaluate the efficacy and safety of arformoterol tartrate inhalation solution 30μg/4mL QD (two 15μg/2mL dosed in combination) over a 24-hour period compared to arformoterol tartrate inhalation solution 15μg/2 mL BID in subjects with COPD.
详细描述
This is a modified blind, randomized, multicenter, single dose two-way crossover study to assess the efficacy and safety of arformoterol 15μg BID versus arformoterol 30μg QD in subjects with COPD. Subject participation will last approximately three weeks and will include a screening visit, two 24-hour visits, and a follow up telephone call. 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
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Subjects must have a FEV1/forced vital capacity (FVC) ratio of ≤ 70% at Visit 1.
排除标准
- •Subjects who do not have a 15 pack-year smoking history and a baseline breathlessness severity grade of 2 (as measured by the Modified Medical Research Council [MMRC] Dyspnea Scale Score) at Screening.
- •Subjects with life-threatening/unstable respiratory status, including upper or lower respiratory tract infection, within the previous 30 days prior to Visit
研究组 & 干预措施
15 mcg BID / 30 mcg QD
Arformoterol 15 microgram twice a day (BID) taken each morning and evening for one visit followed by Arformoterol 30 microgram once a day (QD) in the morning and placebo in the evening for the next visit.
干预措施: Placebo (Drug)
30 mcg QD / 15 mcg BID
Arformoterol 30 microgram once a day (QD) in the morning and placebo in the evening for one visit followed by Arformoterol 15 microgram twice a day (BID) in the morning and evening for the next visit.
干预措施: Placebo (Drug)
15 mcg BID / 30 mcg QD
Arformoterol 15 microgram twice a day (BID) taken each morning and evening for one visit followed by Arformoterol 30 microgram once a day (QD) in the morning and placebo in the evening for the next visit.
干预措施: Arformoterol Tartrate Inhalation Solution (Drug)
30 mcg QD / 15 mcg BID
Arformoterol 30 microgram once a day (QD) in the morning and placebo in the evening for one visit followed by Arformoterol 15 microgram twice a day (BID) in the morning and evening for the next visit.
干预措施: Arformoterol Tartrate Inhalation Solution (Drug)
结局指标
主要结局
Time-Normalized Area Under the Change From Pre-Dose Curve for Forced Expiratory Volume in One Second Measured Over 24 Hours
时间窗: 0-24 hours post dose
Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change from pre-dose for a series of FEV1 readings taken within 24 hours of dosing.
次要结局
- Time-Normalized Area Under the Change From Pre-Dose Curve for Forced Expiratory Volume in One Second Measured Over 12 Hours(0-12 hours)
- Time-Normalized Area Under the Change From Pre-Dose Curve for Forced Expiratory Volume in One Second Measured Between 12-24 Hours(12-24 hours)
- Change in Forced Expiratory Volume in One Second From Pre-dose to the 24 Hour Time Point(pre-dose and 24 hours post-dose)
- Forced Expiratory Volume in One Second Measurements Pre-dose and at Each Assessed Time Point Post-dose(pre-dose, immediately post-dose, 30 min, 1,2,4,6,8,10,12, 12.5,13,14,16,23,24 hours post first dose)
- Change in Forced Expiratory Volume in One Second From Pre-dose To Each Assessed Time Point Post-Dose(Immediately post first dose, 30 min, 1,2,4,6,8,10,12,12.5,13,14,16,23,24 hours post first dose)
- Percent of Predicted Forced Expiratory Volume at One Second at Pre-dose and Each Assessed Time Point Post-Dose(Pre-dose, Immediately post first dose, 30 min, 1,2,4,6,8,10,12,12.5,13,14,16,23,24 hours post first dose)
- Change in Percent of Predicted Forced Expiratory Volume at One Second (FEV1) at Each Assessed Time Point Post-Dose Compared to Pre-Dose(Immediately post first dose, 30 min, 1,2,4,6,8,10,12,12.5,13,14,16,23,24 hours post first dose)
- Peak Percent of Predicted Forced Expiratory Volume at One Second (FEV1) Over 12 Hours Post-Dose.(12 hours)
- Peak Change in Forced Expiratory Volume at One Second (FEV1) Within 12 Hours Post Dose Compared to Pre-dose(12 hours)
- Time to Onset of 15 Percent Response Within 12 Hours of Dosing(12 hours post first dose)
- Time to Onset of Response of Both a 12 Percent Increase and 200 Milliliter Increase Within 12 Hours of Dosing(up to 12 hours post dose)
- Time to Onset of Response of Both a 12 Percent Increase and 200 Milliliter Increase in Forced Expiratory Volume in One Second Within 12 Hours of Dosing(pre-dose, immediately post first dose, 30 min, 1,2,4,6,8,10,12, 12.5, 13, 14, 16, 23,24 hours post first dose)
- Change in Forced Vital Capacity From Pre-dose to Each Post-Dose Assessed Time Point(immediately post first dose, 30 min, 1,2,4,6,8,10,12, 12.5, 13, 14, 16, 23,24 hours post first dose)