A Cross-sectional Study to Determine the Proportion and Clinical Characteristics of COPD Patients With Asthma Symptoms in Asia (ACOS) and Describe Current Practices in Diagnosis and Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- proportion of ACOS patients among COPD-diagnosed patients seen at the out-patient clinics
研究概览
简要总结
The purpose of this study to determine the proportion and clinical characteristics of COPD patients with asthma symptoms (ACOS) and describe current practices in diagnosis and management in Viet Nam and Taiwan.
详细描述
Chronic Obstructive Pulmonary Disease (COPD) is a major cause of chronic morbidity and mortality. Around 15% to 20% of COPD patients would present with features of asthma and are considered to have the overlap syndrome of COPD and asthma, commonly called asthma-COPD overlap syndrome (ACOS). In Asia, specifically Taiwan, the overall prevalence of ACOS in patients with COPD is approximately 17.4%. COPD patients with asthma symptoms represent a relevant clinical population because they have worse health-related quality of life.
Given the increased morbidity among COPD patients with asthma overlap, it is critical that these patients are properly characterized to aid the appropriate diagnosis and treatment. The Global Initiative for Asthma (GINA) and Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines have given joint recommendations on the identification, diagnosis and treatment of these patients. These recommendations have been adapted for use in the Asia Area countries. The primary objective of this study is to determine the proportion and clinical characteristics of patients with ACOS as defined by the joint GINA and GOLD recommendation amongst diagnosed COPD patients seen at the out-patient clinics.
This study is planned to determine the proportion of patients with ACOS as defined by the joint GINA and GOLD recommendation amongst diagnosed COPD patients seen at the out-patient clinics
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with confirmed diagnosis of COPD {post-bronchodilator FEV1/FVC<0.7 (FEV1 - forced expiratory volume at one second, FVC - forced vital capacity) based on the medical records}
- •Aged >40 years old at time of diagnosis
- •Seen at out-patient clinic
排除标准
- •Patients currently with acute exacerbation of COPD by GOLD definition (any worsening of a patient's respiratory symptoms that is beyond normal day-to-day variations and requires a change in medication)
- •Patients with respiratory diseases that can show similar symptoms to chronic airway diseases such as bronchiectasis, tuberculosis (TB)-destroyed lung parenchyma, endobronchial TB, and lung cancer, or those who have history of these diseases based on physician's judgment
- •Patients currently diagnosed with pneumonia and acute bronchitis
- •Patients currently randomized in other clinical studies
结局指标
主要结局
proportion of ACOS patients among COPD-diagnosed patients seen at the out-patient clinics
时间窗: 6 month
To determine the proportion and clinical characteristics of patients with Asthma-COPD Overlap Syndrome (ACOS) as defined by the joint GINA and GOLD recommendation amongst diagnosed COPD patients seen at the out-patient clinic.
次要结局
- symptom control assessment(6 months)