跳至主要内容
临床试验/NCT01328145
NCT01328145Unknown2 期

Acetylic Salicylic Acid for the Treatment of Chronic Obstructive Pulmonary Disease (COPD). A Randomized, Double-blind, Placebo-controlled Trial

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2011年4月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

干预措施: Acetylsalicylic acid (Drug)

Placebo

Placebo Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rolf Ziesche

Professor

Medical University of Vienna

研究点 (1)

Loading locations...

相似试验

Acetylic Salicylic Acid for the Treatment of Chronic... | 临床试验