NCT01032304Unknown3 期
The Efficacy and Safety of Erdosteine in the Long-term Therapy of Chronic Obstructive Pulmonary Disease (COPD). A 12-month, Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicenter Study
Edmond Pharma44 个研究点 分布在 10 个国家目标入组 492 人开始时间: 2009年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 492
- 试验地点
- 44
- 主要终点
- number of acute exacerbations
研究概览
简要总结
The aim of the study is to evaluate the effect of erdosteine, compared to placebo, on exacerbation rate over a 12-month treatment period in patients with moderate-to-severe COPD. Moreover, the effects of erdosteine on pulmonary function parameters, clinical symptoms and quality of life, and the long-term safety of the drug will be assessed.
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
- •COPD stage II-III GOLD
- •At least 2 exacerbations in the previous 2-12 months
排除标准
- •Acute exacerbations in the 2 months prior to enrolment
- •Diagnosis of asthma and/or other relevant lung diseases
- •COPD stage IV
- •Unstable concurrent diseases
研究组 & 干预措施
Erdosteine
Experimental
600 mg/day for 12 months
干预措施: Erdosteine (Drug)
Placebo
Placebo Comparator
Placebo for 12 months
干预措施: Placebo (Drug)
结局指标
主要结局
number of acute exacerbations
时间窗: 12 months
次要结局
- Quality of life(12 months)
- Safety and tolerability of erdosteine(12 months)
- spirometry parameters(12 months)
- COPD symptoms(12 months)
研究者
研究点 (44)
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