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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04853238
Other study ID # 213550
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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