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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04853238
• Other study ID #: 213550
• Status: Completed
• Start date: April 27, 2021
• Est. completion date: February 6, 2023

Study information

• Verified date: November 2023
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1507
• Est. completion date: February 6, 2023
• Est. primary completion date: November 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Prospective observational cohort study
Prospective observational cohort study

Locations

Country	Name	City	State
China	GSK Investigational Site	Beijing
China	GSK Investigational Site	Beijing
China	GSK Investigational Site	Cangzhou
China	GSK Investigational Site	Chengdu
China	GSK Investigational Site	Chongqing
China	GSK Investigational Site	Chongqing
China	GSK Investigational Site	Hangzhou
China	GSK Investigational Site	Hefei
China	GSK Investigational Site	Huizhou	Guangdong
China	GSK Investigational Site	Jiangmen	Guangdong
China	GSK Investigational Site	Jinan	Shandong
China	GSK Investigational Site	Jinan	Shandong
China	GSK Investigational Site	Jingzhou
China	GSK Investigational Site	Luoyang
China	GSK Investigational Site	Nanchang
China	GSK Investigational Site	Nanning
China	GSK Investigational Site	Nanning	Guangxi
China	GSK Investigational Site	Nanyang
China	GSK Investigational Site	Pingdingshan
China	GSK Investigational Site	Shanghai
China	GSK Investigational Site	Shanghai
China	GSK Investigational Site	Shanxi
China	GSK Investigational Site	Shaoguan	Guangdong
China	GSK Investigational Site	Shenyang	Liaoning
China	GSK Investigational Site	Shenyang
China	GSK Investigational Site	Shenzhen	Guangdong
China	GSK Investigational Site	Taiyuan	Shanxi
China	GSK Investigational Site	Tianjin
China	GSK Investigational Site	Tianjin
China	GSK Investigational Site	Wuhan
China	GSK Investigational Site	Wuhan	Hubei
China	GSK Investigational Site	Xi'an
China	GSK Investigational Site	Xian	Shaanxi
China	GSK Investigational Site	Xiangtan
China	GSK Investigational Site	Yibin
China	GSK Investigational Site	Yibin
China	GSK Investigational Site	Yinchuan	Ningxia
China	GSK Investigational Site	Zhejiang	Zhejiang
China	GSK Investigational Site	Zhengzhou

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants by each COPD maintenance treatment		Up to 3 months
Secondary	Percentage of participants with disease severity and socio-economic factors by each COPD maintenance treatment		Baseline (Day 1)
Secondary	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
Secondary	Percentage of participants by their Modified British Medical Research Council (mMRC) score at Baseline		Baseline (Day 1)
Secondary	Percentage of participants by their COPD assessment test (CAT) score		Up to 3 months
Secondary	Number of participants with history of exacerbations within 1 year prior to Baseline visit		Within 1 year prior to Baseline visit (Day 1)
Secondary	Percentage of participants receiving each treatment class at 3 months		At 3 months