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

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 350

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsing, Taiwan
    • Research Site
  • Taichung, Taiwan
    • Research Site
  • Taipei, Taiwan
    • Research Site
• Vietnam
  • Ha Noi, Vietnam
    • Research Site
  • Ho Chi Minh, Vietnam
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients diagnosed with COPD who are seen at the outpatient clinics of Pulmonary Specialists

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
proportion of ACOS patients among COPD-diagnosed patients seen at the out-patient clinics	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.	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
symptom control assessment	To review the current practices of symptom control assessment	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
medications given to ACOS patients in current practice	To review the medications given to COPD patients with asthma compared to guideline recommendations	6 months

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: ASK CRE Private Limited

Publications and helpful links

Helpful Links

• CSR Synopsis

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2016
• Primary Completion (Actual): April 28, 2017
• Study Completion (Actual): April 28, 2017

Study Registration Dates

• First Submitted: August 22, 2016
• First Submitted That Met QC Criteria: August 22, 2016
• First Posted (Estimate): August 25, 2016

Study Record Updates

• Last Update Posted (Actual): April 30, 2018
• Last Update Submitted That Met QC Criteria: April 27, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: COPD, Asthma, ACOS
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Disease; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Pulmonary Disease, Chronic Obstructive; Syndrome; Asthma; Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome
• Other Study ID Numbers: D2287R00106