Clinical trial NCT04853238: Chronic Obstructive Pulmonary Disease (COPD) Maintenance Treatment Patterns in China
Official title: COPD Disease Burden, Patient Characteristics, Maintenance Treatment Patterns and Factors Influencing Treatment Decisions in China Tier 2 and Tier 3 Hospitals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Chronic obstructive pulmonary disease
China
Disease burden
Maintenance treatment patterns
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2021-04-21
Enrollment: 1507
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline
timeFrame: At Baseline (Day 1)
measure: Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months
timeFrame: At 3 months
measure: Number of Participants With Moderate Acute Exacerbation Requiring no Hospitalization by Each COPD Maintenance Treatment at Follow-up (Week 1)
timeFrame: At Week 1
measure: Number of Participants With Acute Exacerbation Requiring Hospitalization by Each COPD Maintenance Treatment at Discharge Follow-up (up to 28 Days)
timeFrame: At Discharge follow-up (up to 28 days)
Secondary outcomes:
measure: Mean Forced Expiratory Volume in One Minute (FEV1) at Baseline
timeFrame: At Baseline (Day 1)
measure: Number of Participants With History of Exacerbations in Within 1 Year Prior to Baseline
timeFrame: Within 1 year prior to Baseline (Day 1) visit
measure: Number of Participants With COPD Medication History
timeFrame: At Pre-Baseline (Within 1 month before Baseline [Day 1] visit)
measure: Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Scores by Historic Treatments at Indicated Time Point
timeFrame: At 3 months
measure: Modified Medical Research Council (mMRC) Score by Historic Treatments at Indicated Time Point
timeFrame: At 3 months
measure: Number of Participants Requiring Hospitalization by Their Each Dyspnea, Eosinopenia, Consolidation, Acidemia and Atrial Fibrillation (DECAF) Risk Group
timeFrame: Baseline (Day 1)
measure: Number of Participants With at Least One Co-morbidity
timeFrame: Up to 3 months
measure: Number of Participants by Their Socio-economic Characteristics
timeFrame: Baseline (Day 1)
measure: Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points
timeFrame: Baseline (Day 1), Week 1, Discharge follow-up (up to 28 days) and at 3 months
measure: Number of Participants by Their Modified British Medical Research Council (mMRC) Score at Baseline
timeFrame: At Baseline (Day 1)
measure: Number of Participants Whose Prescribed Maintenance Treatment Was Stepped up, Stepped Down, Stopped, Switched, Remained the Same
timeFrame: Up to 3 months
measure: Number of Participants Receiving COPD Maintenance Treatment at 3 Months
timeFrame: At 3 months
Other outcomes:
Locations:
city: Huizhou
country: China
facility: GSK Investigational Site
state: Guangdong
city: Jiangmen
country: China
facility: GSK Investigational Site
state: Guangdong
city: Shaoguan
country: China
facility: GSK Investigational Site
state: Guangdong
city: Shenzhen
country: China
facility: GSK Investigational Site
state: Guangdong
city: Nanning
country: China
facility: GSK Investigational Site
state: Guangxi
city: Wuhan
country: China
facility: GSK Investigational Site
state: Hubei
city: Shenyang
country: China
facility: GSK Investigational Site
state: Liaoning
city: Yinchuan
country: China
facility: GSK Investigational Site
state: Ningxia
city: Xian
country: China
facility: GSK Investigational Site
state: Shaanxi
city: Jinan
country: China
facility: GSK Investigational Site
state: Shandong
city: Jinan
country: China
facility: GSK Investigational Site
state: Shandong
city: Taiyuan
country: China
facility: GSK Investigational Site
state: Shanxi
city: Zhejiang
country: China
facility: GSK Investigational Site
state: Zhejiang
city: Beijing
country: China
facility: GSK Investigational Site
city: Beijing
country: China
facility: GSK Investigational Site
city: Cangzhou
country: China
facility: GSK Investigational Site
city: Chengdu
country: China
facility: GSK Investigational Site
city: Chongqing
country: China
facility: GSK Investigational Site
city: Chongqing
country: China
facility: GSK Investigational Site
city: Hangzhou
country: China
facility: GSK Investigational Site
city: Hefei
country: China
facility: GSK Investigational Site
city: Jingzhou
country: China
facility: GSK Investigational Site
city: Luoyang
country: China
facility: GSK Investigational Site
city: Nanchang
country: China
facility: GSK Investigational Site
city: Nanning
country: China
facility: GSK Investigational Site
city: Nanyang
country: China
facility: GSK Investigational Site
city: Pingdingshan
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Shanxi
country: China
facility: GSK Investigational Site
city: Shenyang
country: China
facility: GSK Investigational Site
city: Tianjin
country: China
facility: GSK Investigational Site
city: Tianjin
country: China
facility: GSK Investigational Site
city: Wuhan
country: China
facility: GSK Investigational Site
city: Xi'an
country: China
facility: GSK Investigational Site
city: Xiangtan
country: China
facility: GSK Investigational Site
city: Yibin
country: China
facility: GSK Investigational Site
city: Yibin
country: China
facility: GSK Investigational Site
city: Zhengzhou
country: China
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: