Acetylic Salicylic Acid for the Treatment of Chronic Obstructive Pulmonary Disease (COPD). A Randomized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Change in FEV1 (forced expiratory volume in 1 second) after 12 weeks of treatment
研究概览
简要总结
The pathomechanisms of COPD are still not fully understood, and up to now there is no satisfying causal treatment inhibiting the progress of the disease. Available therapy is in most cases symptomatic. Experimental and clinical observations suggest that treatment with ASA might be beneficial in the treatment of COPD in terms of respiratory and lung-functional improvement.
To evaluate the efficacy of ASA as add-on therapy in COPD in comparison to placebo a prospective, randomized, double-blind, placebo controlled study will be conducted. Adult male and female patients (n=74) with proven COPD GOLD grade II-III will be randomized to 2 groups (i.e. 37 patients per group, stratification according to smoking status and gender). They will receive either 500 mg ASA per day or matching placebo over 12 weeks. Primary efficacy endpoints are changes in the lung-functional parameter FEV1 (forced expiratory 1-second volume) after 12 weeks of treatment. Secondary endpoints are the health score of the St. Georges respiratory questionnaire (SGRQ) and Peak-flow (PEF).
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
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD GOLD II or III
排除标准
- •Long term NSAIDS, pregnancy et al.
研究组 & 干预措施
ASA
干预措施: Acetylsalicylic acid (Drug)
Placebo
干预措施: Acetylsalicylic acid (Drug)
结局指标
主要结局
Change in FEV1 (forced expiratory volume in 1 second) after 12 weeks of treatment
时间窗: 12 weeks
lung functional testing
次要结局
未报告次要终点
研究者
Rolf Ziesche
Professor
Medical University of Vienna
