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

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04853238

Collaborator

(none)

1,500

Enrollment

Locations

23.1

Anticipated Duration (Months)

45.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Disease, Chronic Obstructive	Other: Prospective observational cohort study

Study Design

Study Type:

Observational

Anticipated Enrollment :

1500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 27, 2021

Anticipated Primary Completion Date :

Mar 31, 2023

Anticipated Study Completion Date :

Mar 31, 2023

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Percentage of participants by each COPD maintenance treatment [Up to 3 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Huizhou	Guangdong	China	516000
2	GSK Investigational Site	Jiangmen	Guangdong	China	529100
3	GSK Investigational Site	Shaoguan	Guangdong	China	512600
4	GSK Investigational Site	Shenzhen	Guangdong	China	518020
5	GSK Investigational Site	Nanning	Guangxi	China	530021
6	GSK Investigational Site	Wuhan	Hubei	China	430014
7	GSK Investigational Site	Yinchuan	Ningxia	China	750001
8	GSK Investigational Site	Xian	Shaanxi	China	710000
9	GSK Investigational Site	Jinan	Shandong	China	250014
10	GSK Investigational Site	Jinan	Shandong	China	250101
11	GSK Investigational Site	Taiyuan	Shanxi	China	030006
12	GSK Investigational Site	Zhejiang	Zhejiang	China	314399
13	GSK Investigational Site	Beijing		China	100029
14	GSK Investigational Site	Chengdu		China	610000
15	GSK Investigational Site	Chongqing		China	400000
16	GSK Investigational Site	Chongqing		China	400010
17	GSK Investigational Site	Hefei		China	230001
18	GSK Investigational Site	Jingzhou		China	434020
19	GSK Investigational Site	Luoyang		China	471003
20	GSK Investigational Site	Nanchang		China	330006
21	GSK Investigational Site	Nanning		China	530405
22	GSK Investigational Site	Shanghai		China	200000
23	GSK Investigational Site	Shanghai		China	200032
24	GSK Investigational Site	Shanxi		China	037008
25	GSK Investigational Site	Shenyang		China	110024
26	GSK Investigational Site	Tianjin		China	300052
27	GSK Investigational Site	Tianjin		China	300480
28	GSK Investigational Site	Wuhan		China	430015
29	GSK Investigational Site	Xi'an		China	710600
30	GSK Investigational Site	Xiangtan		China	411100
31	GSK Investigational Site	Yibin		China	629000
32	GSK Investigational Site	Yibin		China	644000
33	GSK Investigational Site	Zhengzhou		China	450000