A Multicentre, Randomised, Partially Blinded, Placebo-controlled, Three-way Crossover, Incomplete Block Design Study to Investigate the Safety, Tolerability, Pharmacodynamics/ Efficacy and Pharmacokinetics of Dual Bronchodilator Therapy With Salmeterol 50µg Twice-daily Plus Two Different Doses of GSK233705B (20 and 50µg Twice-daily), Compared With Placebo, Salmeterol 50µg Twice-daily Alone, and Tiotropium 18µg Once-daily Alone, in Subjects With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 12
- 主要终点
- Bronchodilator effect of GSK233705 plus salmeterol at day 7, compared with placebo in COPD subjects.
研究概览
简要总结
The safety, tolerability, pharmacokinetics and pharmacodynamics/efficacy profiles of two different doses of GSK233705 will be compared with 2 active comparators and placebo, all medication delivered via dry powder inhaler.
详细描述
A multi-centre, randomised, partially blinded, placebo-controlled, three-way crossover, incomplete block design study to investigate the, safety, tolerability, pharmacodynamics/efficacy and pharmacokinetics of dual bronchodilator therapy with salmeterol 50 mcg twice daily plus two different doses of GSK233705 (20 and 50 mcg twice daily), compared with placebo, salmeterol 50 mcg twice daily alone, and tiotropium 18 mcg once daily alone, in subjects with chronic obstructive pulmonary disease
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
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •females of non-childbearing potential or postmenopausal;
- •history of COPD as defined by ATS/ERS criteria;
- •moderate COPD responsive to ipratropium and salbutamol;
- •current smoker or ex-smoker.
排除标准
- •no instable COPD; max 1000 mcg inhaled steroids per day; no B-blockers
结局指标
主要结局
Bronchodilator effect of GSK233705 plus salmeterol at day 7, compared with placebo in COPD subjects.
次要结局
- Bronchodilator effect of salmeterol alone and tiotropium alone compared with placebo and GSK233705 at day 7. Safety and tolerability of GSK233705 plus salmeterol and the 2 active comparators at day 7.