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

• ClinicalTrials.gov Identifier: NCT02878252
• Recruitment Status: Completed
• First Posted: August 25, 2016
• Last Update Posted: April 30, 2018
• Sponsor: AstraZeneca
• Collaborator: ASK CRE Private Limited
• Information provided by (Responsible Party): AstraZeneca

Study Description

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.

Condition or disease
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 Design

• Study Type: Observational
• Actual Enrollment: 350 participants
• Observational Model: Other
• Time Perspective: Cross-Sectional
• Official Title: 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
• Actual Study Start Date: October 4, 2016
• Actual Primary Completion Date: April 28, 2017
• Actual Study Completion Date: April 28, 2017

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. proportion of ACOS patients among COPD-diagnosed patients seen at the out-patient clinics [ Time Frame: 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 :

1. symptom control assessment [ Time Frame: 6 months ]
   To review the current practices of symptom control assessment

Other Outcome Measures:

1. medications given to ACOS patients in current practice [ Time Frame: 6 months ]
   To review the medications given to COPD patients with asthma compared to guideline recommendations

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

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

Criteria

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

Contacts and Locations

Locations

Taiwan

Research Site

Kaohsing, Taiwan

Research Site

Taichung, Taiwan

Research Site

Taipei, Taiwan

Vietnam

Research Site

Ha Noi, Vietnam

Research Site

Ho Chi Minh, Vietnam

Sponsors and Collaborators

AstraZeneca

ASK CRE Private Limited

More Information

Additional Information:

CSR Synopsis 

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT02878252
• Other Study ID Numbers: D2287R00106
• First Posted: August 25, 2016
• Last Update Posted: April 30, 2018
• Last Verified: April 2018

Keywords provided by AstraZeneca:

COPD, Asthma, ACOS

Additional relevant MeSH terms:

Asthma; Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome; Syndrome; Disease; Pathologic Processes; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pulmonary Disease, Chronic Obstructive; Chronic Disease; Disease Attributes