Non-interventional Study of COPD Patients With Asthma Overlap Syndrome in Viet Nam and Taiwan

Completed

• Conditions: Patients With Asthma-COPD Overlap Syndrome (ACOS)

• Registration Number: NCT02878252
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2016-08-22
• Study First Submitted QC: 2016-08-22
• Study First Posted: 2016-08-25
• Study Start: 2016-10-04
• Primary Completion: 2017-04-28
• Study Completion: 2017-04-28
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-27
• Last Update Posted: 2018-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
proportion of ACOS patients among COPD-diagnosed patients seen at the out-patient clinics	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.

Secondary Outcome Measures

Name	Time	Method
symptom control assessment	6 months	To review the current practices of symptom control assessment

Trial Locations

Locations (1)

Research Site; 🇻🇳 Ho Chi Minh, Vietnam