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

NCT ID: NCT02878252

Last Updated: 2018-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-04

Study Completion Date

2017-04-28

Brief Summary

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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

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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

Conditions

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Patients With Asthma-COPD Overlap Syndrome (ACOS)

Keywords

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COPD, Asthma, ACOS

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ASK CRE Private Limited

UNKNOWN

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Kaohsing, , Taiwan

Site Status

Research Site

Taichung, , Taiwan

Site Status

Research Site

Taipei, , Taiwan

Site Status

Research Site

Hà Nội, , Vietnam

Site Status

Research Site

Ho Chi Minh City, , Vietnam

Site Status

Countries

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Taiwan Vietnam

Related Links

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http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3988&filename=CSR_synopsis_(ACOS_NIS_Study)TWVN.pdf

CSR Synopsis

Other Identifiers

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D2287R00106

Identifier Type: -

Identifier Source: org_study_id