Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the Combination of GSK573719 and GW642444 in Subjects With COPD
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Change From Baseline in Weighted Mean Pulse Rate Over 0 to 6 Hours Post-dose at Day 28
研究概览
简要总结
The study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of the combination of inhaled GSK573719 and GW64244 compared to placebo, in subjects with COPD.
详细描述
This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability of the combination of GSK573719 (500mcg) Inhalation Powder and GW642444 (25mcg) Inhalation Powder administered once-daily via a novel dry powder inhaler (Novel DPI) over 28 days 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A signed and dated written informed consent prior to study participation
- •Males or females of non-childbearing potential
- •40 or more years of age
- •COPD diagnosis
- •10 pack-years history or greater of cigarette smoking
- •Post-bronchodilator FEV1/FVC ratio of 0.70 or less
- •Post-bronchodilator FEV1 of 80% or less of predicted normal
排除标准
- •Current diagnosis of asthma
- •Other significant respiratory disorders besides COPD, including alpha-1 deficiency
- •Previous lung resection surgery
- •Significant abnormalities in chest x-ray presentation
- •Use of oral steroids, antibiotics or hospitalization for a COPD exacerbation within 3 motnhs prior screening
- •Any significant disease that would put subject at risk through study participation
- •BMI greater than 35
- •Pacemaker
- •Significantly abnormal ECG, Holter, or clinical lab finding (including Hepatitis B or C)
- •Allergy or hypersensitivity to anticholinergics or inhaler excipients
- •Diseases that would contra-indicate the use of anticholinergics
- •Use of oral corticosteroids within 6 weeks of screening
- •Use of long-acting beta-agonists within 48 hours of screening
- •Use of tiotropium within 14 days of screening
- •Use of theophyllines or anti-leukotrienes within 48 hours of screening
- •Use of short-acting bronchodilators within 4 hours of screening
- •Use of investigational medicines within 30 days of screening
- •Use of high dose inhaled corticosteroids
- •Use of long-term oxygen therapy, CPAP or NIPPV
- •Previous use of GSK573719 or GW642444
研究组 & 干预措施
GSK573719/GW642444
干预措施: 500mcg/25mcg once daily (Drug)
Placebo
干预措施: Placebo once daily (Drug)
结局指标
主要结局
Change From Baseline in Weighted Mean Pulse Rate Over 0 to 6 Hours Post-dose at Day 28
时间窗: Baseline and Day 28
Pulse rate is defined as the number of heartbeats in a minute. The weighted mean pulse rate was derived by calculating the area under the pulse rate/time curve (AUC), and then dividing the value by the time interval over which the AUC was calculated. The weighted mean pulse rate was calculated using the 0 to 6 hours post dose measurements at Day 28, which included pre-dose, and post-dose 15 minutes, 45 minutes, 1.5 hours, 3 hours and 6 hours. Baseline pulse rate is the most recent result taken on or before pre-dose Day 1. Change from Baseline is the weighted mean pulse rate at Day 28 minus the Baseline value. Analysis was performed using a repeated measures model with covariates of Baseline pulse rate, sex, age, smoking status, treatment and day and day by treatment and day by Baseline interactions.
次要结局
- Change From Baseline in Weighted Mean Pulse Rate Over 0 to 6 Hours Post-dose at Day 1 and Day 14(Baseline, Day 1, and Day 14)
- Change From Baseline in Maximum and Minimum Pulse Rate 0 to 6 Hours Post-dose on Days 1, 14, and 28(Baseline, Day 1, Day 14 and Day 28)