A Cross-sectional Study to Assess the Proportion and Clinical Characteristics of Asthma and COPD Overlap for Patients With Asthma and COPD in Hong Kong.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,600
- 试验地点
- 1
- 主要终点
- Percentage of prevalence of Asthma COPD overlap among the asthma and COPD subjects.
研究概览
简要总结
This study is to assess the prevalence of Asthma COPD Overlap in subjects with diagnosed asthma and chronic obstructive pulmonary disease (COPD). The subsequent morbidity and mortality of subjects will be followed up for 3 years.
详细描述
Rationale:
Around 15 to 20% of COPD patients have features of asthma. These patients have more frequent and more severe exacerbations, and higher medical utilization. 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 having Asthma-COPD Overlap (ACO). These are at present expert opinions and further studies are needed to establish the optimal definitions and treatment options. The recommendations proposed by the guidelines have been adapted for use in the Asia area countries. Nonetheless, the application to clinical practice has not been well established and there are no prevalence data available on the COPD with asthma symptom population or asthma with COPD symptoms population based on the recommended features for identification. This is the current data gap in Asia.
Primary objective:
To determine the proportion and clinical characteristics of patients with ACO as defined by the joint GINA and GOLD recommendation amongst diagnosed COPD and asthma patients seen at the out-patient clinics
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must fulfil all of the following criteria:
- •All patients with confirmed diagnosis of COPD (post-bronchodilator FEV1/FVC<0.7 based on the medical records) 1 or asthma (defined as those with a consistent history and prior documented evidence of variable airflow obstruction, with evidence of an increase in FEV1 greater than 12% or 400 mL following bronchodilator or bronchial hyperresponsiveness on bronchial provocation testing, when stable) 6
- •Aged >40 years old
- •Signed written informed consent to participate in the study
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) 1 or acute exacerbation of asthma by GINA guideline. 6
- •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
Percentage of prevalence of Asthma COPD overlap among the asthma and COPD subjects.
时间窗: 3 years
To determine the proportion and clinical characteristics of patients with ACO as defined by the joint GINA and GOLD recommendation amongst diagnosed COPD and asthma patients seen at the out-patient clinics. (Assessment: % of subjects with ACO among patients with asthma and COPD respectively)
次要结局
- Percentage of patient with treatment that is different from the guidelines recommendation(3 years)
- The percentages of patients on various medications (e.g. inhaled steroid, LABA, LAMA)(3 years)
- The pecentages of patients receiving different symptoms control assessments (e.g. use of Asthma control test, use of COPD assessment test)(3 years)
- Percentages of subjects with morbidity (e.g. congestive heart failure)(3 years)
- Percentages of subjects with mortality(3 years)
- Percentages of patients with various Genetic markers(3 years)
研究者
Fanny W.S. Ko
Honorary Clinical Associate Professor
Chinese University of Hong Kong