NCT00749411已完成2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, 4-week Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Repeat Inhaled Doses of the Combination of GSK233705 and GW642444 Administered Once-daily in Subjects With COPD
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Change From Baseline in Weighted Mean Pulse Rate Over (0-4 Hours) at Day 28.
研究概览
简要总结
The purpose of this study is the evaluate the safety and tolerability of repeat dosing of the combination of inhaled GSK233705 and GW642444 administered once-daily in subjects with COPD.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male and females 40 to 80 years of age (inclusive)
- •COPD diagnosis
- •Current or previous smokers with a cigarette smoking history of at least 10 pack-
- •Post-albuterol FEV1/FVC of 0.70 or less
- •Post-albuterol FEV1 of 35% to 80% (inclusive)
排除标准
- •Pregnant or lactating females
- •current diagnosis of asthma
- •respiratory disorders other than COPD
- •clinically significant cardiovascular, neurological, psychiatric, renal, immunological, endocrine, or hematological abnormalities that are uncontrolled
- •clinically significant sleep apnea
- •previous lung resection surgery
- •clinically significant abnormalities confirmed by chest x-ray that are not related to COPD
- •hospitalization for COPD within 3 months of screening
- •use of antibiotics for lower respiratory tract infection within 6 months of screening
- •abnormal and clinically significant 12-lead ECG findings
- •current malignancy in remission for less that 5 years
- •medical conditions that would contraindicate the use of anticholinergics
- •positive hepatitis B or C test
- •history of alcohol or drug abuse
- •unable to withhold albuterol for 6 or more hours
- •use of long term oxygen therapy
- •conditions that would limit the validity of informed consent
- •use of GW642444 or GSK233705 in previous studies
- •use of an investigation drug with 30 days of screening
- •use of inhaled corticosteroids (ICS) at a dose greater than 1000mcg of fluticasone propionate or equivalent
- •hypersensitivity to beta-agonists
- •concurrent use of long-acting beta-agonists (LABA) or long-acting muscaring antagonists, LABA/ICS combination products, cytochrome p450 inhibitors, oral or depot corticosteroids, theophyllines, oral beta agonists, oral leukotrine modulators, inhaled short acting anticholinergics.
研究组 & 干预措施
Arm 1
Experimental
干预措施: GSK233705/GW642444 (Drug)
Arm 2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Weighted Mean Pulse Rate Over (0-4 Hours) at Day 28.
时间窗: Baseline (Pre-dose, Day 1) and Day 28
Baseline was the most recent result taken on or before pre-dose (Day 1). The analysis was performed using a Repeated Measures Model. This model used all available weighted mean pulse rate values recorded. Change from Baseline was calculated as (Change from Baseline = Assessment value - Baseline value).
次要结局
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(On-treatment; from treatment start until one day after treatment stop (Up to Day 29))
研究者
研究点 (1)
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