NCT00144859已完成2 期
A 28-day, Randomised, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Anti-inflammatory Effect and Steady-state Pharmacokinetics of SB-681323 7.5 mg Per Day in Patients With Chronic Obstructive Pulmonary Disease.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 18
- 主要终点
- Safety and tolerability as assessed by incidence of elevated liver function tests. Serum concentration c-reactive protein (CRP)
研究概览
简要总结
This is a 28-day, placebo controlled clinical study assessing the safety, tolerability anti-inflammatory effect and pharmacokinetics of SB681323 in patients with COPD (Chronic Obstructive Pulmonary Disease).
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
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
- •Non-childbearing potential.
- •Clinical diagnosis of COPD.
- •Cigarette smoking history of greater than or equal to 10 pack years.
- •Post-bronchodilator FEV1 to FVC ratio (FEV1:FVC) < 0.7
- •Post-bronchodilator FEV1 50% - 80% of predicted normal.
- •Receiving inhaled corticosteroids for a minimum of 6 weeks prior to Screening.
- •Serum CRP concentration greater than 3mg/L.
排除标准
- •Current diagnosis of asthma.
- •Active tuberculosis, sarcoidosis or bronchiectasis.
- •History of any type of malignancy, rheumatoid arthritis or other conditions associated with chronic inflammation.
- •Clinically significant renal or hepatic disease.
- •History of increased liver function tests, or patients receiving hormone replacement therapy, statins or systemic or topical corticosteroids.
结局指标
主要结局
Safety and tolerability as assessed by incidence of elevated liver function tests. Serum concentration c-reactive protein (CRP)
次要结局
- Inflammatory markers in blood and sputum Spirometric lung function tests Dyspnoea measured by the TDI Safety assessments Population Pharmacokinetics
研究者
研究点 (18)
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