A Double-Blind, Randomized, Multicenter, Parallel-Group Study of Levalbuterol in the Treatment of Subjects With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 257
- 主要终点
- The primary efficacy endpoint was the time-normalized area under the percent change from visit predose in FEV1 curve (nAUC0-8 hours) averaged over the six week double-blind period.
研究概览
简要总结
To investigate the efficacy and safety of repeated dosing of Levalbuterol over 6 weeks of treatment in COPD.
详细描述
This study is a multi-center, randomized, double-blind, placebo and active controlled, parallel-group study of adult subjects with COPD. Approximately 250 subjects will be enrolled to randomize at least 200 subjects. Study participation will consist of a total of six study visits over nine weeks for each subject. 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 99 Years（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 greater than or equal to 35 years of age at the time of consent.
- •Subjects must have a pre-established primary clinical diagnosis of COPD.
- •Subjects must have a baseline FEV1 less than or equal to 65%
- •Subjects must have a predicted and >0.70 Liter
- •subject was taking steroids (inhaled, oral, or nasal), short-acting xanthines, or leukotrienes, the dose must have been stable for 30 days
- •Subjects must have a FEV1/forced vital capacity (FVC) less than or equal to 70%
- •Subjects must have a greater than or equal to 15 pack-year smoking history
- •Subjects must have a baseline medical research council (MRC) dyspnea scale score greater than or equal to 2
- •Regular use of a prescribed therapy for control of COPD symptoms for 3 months prior to study entry.
- •No COPD exacerbations that have required an emergency room visit, hospital admission or intensive out-patient therapy within 1 month prior to study entry
排除标准
- •Females who are pregnant or lactating.
- •Concurrent requirement of oxygen therapy
- •Known history of asthma, or any chronic respiratory disease other than COPD (not including chronic bronchitis or emphysema).
- •Diagnosis of cancer within 5 years prior to study entry with the exception of non-melanoma skin cancer.
- •Lung resection of more than one full lobe.
- •Use of intravenous, intra-articular or intramuscular corticosteroids within 30 days of study entry
- •History of upper or lower respiratory infection within 14 days of study entry.
- •Participation in an investigational drug study within 30 days of study entry.
研究组 & 干预措施
1
Levalbuterol 0.63 mg TID
干预措施: Levalbuterol HCl (Drug)
2
Levalbuterol 1.25 mg TID
干预措施: Levalbuterol HCl (Drug)
3
Racemic Albuterol 2.5 mg TID
干预措施: Albuterol Sulfate (Drug)
4
Placebo TID
干预措施: Placebo (Drug)
结局指标
主要结局
The primary efficacy endpoint was the time-normalized area under the percent change from visit predose in FEV1 curve (nAUC0-8 hours) averaged over the six week double-blind period.
时间窗: Days -21, -14, 0, 14, 28, and 42
次要结局
- Subject and physician global evaluations(Days 14, 28, 42)
- COPD symptom ratings(Days 0, 14, 28, 42)
- Ipatropium Bromide MDI use(Day 0, 14, 28, 42)
- Short acting Beta-agonist MDI use(Days 0, 14, 28, 42)
- Spirometry parameters(Days -21, -14, 0, 14, 28, and 42)
- Exacerbations of COPD(Days -14, 0, 14, 28, 42)
- Baseline dyspnea and transitional dyspnea indices(Days 0, 14, 28, 42)
- St. George's Hospital Respiratory Questionnaire (SGRQ).(Days 0, 42)