Patient Characteristics and Treatment Modalities in COPD Patients in China

NCT ID: NCT03161587

Last Updated: 2019-06-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 848 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-31
• Study Completion Date: 2018-12-31

Brief Summary

Chronic obstructive pulmonary disease (COPD) is a complex disease characterized by multiple clinical manifestations as well as co-morbidities. While COPD subjects have traditionally been classified based solely on airflow limitation (forced expiratory volume in one second [FEV1]), a new classification system was introduced in the year of 2011 by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) that recommended subjects with COPD should be classified based on a combination of airflow limitation, disease impact (determined by symptom burden and activity limitation) and history of exacerbation. This approach results in the classification of subjects in four groups: A (low risk, less symptoms), B (low risk, more symptoms), C (high risk, less symptoms), and D (high risk, more symptoms). This classification system was further refined in year 2013, specifically around the history of exacerbation definition, where having ≥1 exacerbation leading to hospital admission in preceding year was added as a criteria for classification into the "high risk" C or D groups. Further, in the year 2016, there was a refinement of the disease impact criteria that suggest the use of the COPD Assessment Test (CAT) score (over the Modified British Medical Research Council Dyspnea Scale [mMRC] score) as the preferred tool to determine classification as "more symptoms" or "less symptoms". This study aims to understand subject characteristics and current treatment modalities in different groups classified by GOLD 2016 comprehensive classification system and to understand if current treatment choice is concordant with the GOLD recommendations in real life clinical practice in China tertiary hospitals. It will provide a useful point-in-time description of COPD subject characteristics and current treatment modalities in real life clinical practice in China.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Subjects with COPD

Subjects with diagnosis of COPD at least one year, visiting outpatient clinics in tertiary hospitals in China and in stable state at enrolment.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Aged 40 years and older
• A clinical diagnosis of COPD for at least one year: dyspnea, chronic cough or sputum production, and a history of exposure to risk factors for the disease and lung function test FEV1/ FVC <0.7(post bronchodilator)
• Out-patient
• Able to read, comprehend, and record information in Chinese

Exclusion Criteria

• Current exacerbation or an exacerbation within the preceding one month
• Other unstable diseases which could influence CAT and lung function results (judged by physicians)
• A medical diagnosis of active tuberculosis, cystic fibrosis, any other pulmonary condition, lung cancer, or hypereosinophilic syndromes (HES)
• Currently participating in another COPD clinical study which provides the subject investigational medication and/or disease management

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Xiamen, Fujian, China

GSK Investigational Site

Guangzhou, Guangdong, China

GSK Investigational Site

Changsha, Hunan, China

GSK Investigational Site

Hohhot, Inner Mongolia, China

GSK Investigational Site

Chengdu, Sichuan, China

GSK Investigational Site

Beijing, , China

GSK Investigational Site

Shanghai, , China

GSK Investigational Site

Zhengzhou, , China

Countries

China

Other Identifiers

207136

Identifier Type: -

Identifier Source: org_study_id