Chronic Obstructive Pulmonary Disease (COPD) Maintenance Treatment Patterns in China

COPD Disease Burden, Patient Characteristics, Maintenance Treatment Patterns and Factors Influencing Treatment Decisions in China Tier 2 and Tier 3 Hospitals

This observational study will be conducted in COPD participants in Tier 2 and 3 hospitals in China to gain an understanding of the complex COPD management and physician's treatment strategy.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Other: Prospective observational cohort study

• Study Type: Observational
• Enrollment (Actual): 1507

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100029
    • GSK Investigational Site
  • Beijing, China, 102399
    • GSK Investigational Site
  • Cangzhou, China, 061001
    • GSK Investigational Site
  • Chengdu, China, 610000
    • GSK Investigational Site
  • Chongqing, China, 400000
    • GSK Investigational Site
  • Chongqing, China, 400010
    • GSK Investigational Site
  • Hangzhou, China, 311202
    • GSK Investigational Site
  • Hefei, China, 230001
    • GSK Investigational Site
  • Jingzhou, China, 434020
    • GSK Investigational Site
  • Luoyang, China, 471003
    • GSK Investigational Site
  • Nanchang, China, 330006
    • GSK Investigational Site
  • Nanning, China, 530405
    • GSK Investigational Site
  • Nanyang, China, 473000
    • GSK Investigational Site
  • Pingdingshan, China, 462500
    • GSK Investigational Site
  • Shanghai, China, 200032
    • GSK Investigational Site
  • Shanghai, China, 200000
    • GSK Investigational Site
  • Shanxi, China, 037008
    • GSK Investigational Site
  • Shenyang, China, 110024
    • GSK Investigational Site
  • Tianjin, China, 300052
    • GSK Investigational Site
  • Tianjin, China, 300480
    • GSK Investigational Site
  • Wuhan, China, 430015
    • GSK Investigational Site
  • Xi'an, China, 710600
    • GSK Investigational Site
  • Xiangtan, China, 411100
    • GSK Investigational Site
  • Yibin, China, 629000
    • GSK Investigational Site
  • Yibin, China, 644000
    • GSK Investigational Site
  • Zhengzhou, China, 450000
    • GSK Investigational Site
  • Guangdong
    • Huizhou, Guangdong, China, 516000
      • GSK Investigational Site
    • Jiangmen, Guangdong, China, 529100
      • GSK Investigational Site
    • Shaoguan, Guangdong, China, 512600
      • GSK Investigational Site
    • Shenzhen, Guangdong, China, 518020
      • GSK Investigational Site
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • GSK Investigational Site
  • Hubei
    • Wuhan, Hubei, China, 430014
      • GSK Investigational Site
  • Liaoning
    • Shenyang, Liaoning, China, 110000
      • GSK Investigational Site
  • Ningxia
    • Yinchuan, Ningxia, China, 750001
      • GSK Investigational Site
  • Shaanxi
    • Xian, Shaanxi, China, 710000
      • GSK Investigational Site
  • Shandong
    • Jinan, Shandong, China, 250014
      • GSK Investigational Site
    • Jinan, Shandong, China, 250101
      • GSK Investigational Site
  • Shanxi
    • Taiyuan, Shanxi, China, 030006
      • GSK Investigational Site
  • Zhejiang
    • Zhejiang, Zhejiang, China, 314399
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants with COPD either in stable state or with an acute exacerbation, in Tier 2 and 3 hospitals in China.

Description

Inclusion criteria:

• Male or female participants with minimum 40 years of age.
• A diagnosis of COPD confirmed by spirometry (According to Global initiative for chronic obstructive lung disease [GOLD] 2019 criteria) in Tier 2 and Tier 3 hospitals.
• In hospitalized participants, recruit only participants who receive any intravenous therapy.
• A signed and dated written informed consent.
• Participants can communicate normally.

Exclusion criteria:

• Current primary diagnosis of asthma, active tuberculosis, bronchiectasis, lung cancer or other active pulmonary disease.
• Other unstable diseases or cognitive behavior, which could influence CAT and lung function results (judged by physicians).
• Experienced a moderate/severe COPD exacerbation treated by a physician within last 1 month.
• Currently participating in another COPD clinical study, which provides the participant investigational medication and/or disease management.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1: Participants with newly and previously diagnosed stable disease	Other: Prospective observational cohort study; Prospective observational cohort study
Cohort 2: Participants with moderate acute exacerbation not requiring hospitalization	Other: Prospective observational cohort study; Prospective observational cohort study
Cohort 3: Participants requiring hospitalization for an acute exacerbation	Other: Prospective observational cohort study; Prospective observational cohort study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of participants by each COPD maintenance treatment	Up to 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of participants with disease severity and socio-economic factors by each COPD maintenance treatment	Baseline (Day 1)
Percentage of participants whose prescribed maintenance treatment is stepped up (adding another maintenance treatment), stepped down (withdraw any of, switched, stopped (stop all maintenance treatment) or remained the same	Up to 3 months
Percentage of participants by their Modified British Medical Research Council (mMRC) score at Baseline	Baseline (Day 1)
Percentage of participants by their COPD assessment test (CAT) score	Up to 3 months
Number of participants with history of exacerbations within 1 year prior to Baseline visit	Within 1 year prior to Baseline visit (Day 1)
Percentage of participants receiving each treatment class at 3 months	At 3 months

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Investigators: Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2021
• Primary Completion (Actual): November 3, 2022
• Study Completion (Actual): February 6, 2023

Study Registration Dates

• First Submitted: April 16, 2021
• First Submitted That Met QC Criteria: April 16, 2021
• First Posted (Actual): April 21, 2021

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: China; Chronic obstructive pulmonary disease; Disease burden; Maintenance treatment patterns
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Lung Diseases, Obstructive; Chronic Disease; Lung Diseases; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 213550

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No