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 2: Participants with moderate acute exacerbation not requiring hospitalization	Other: Prospective observational cohort study; Prospective observational cohort study. No study treatment was administered in this study.
Cohort 3: Participants requiring hospitalization for an acute exacerbation	Other: Prospective observational cohort study; Prospective observational cohort study. No study treatment was administered in this study.
Cohort 1: Participants with stable disease	Other: Prospective observational cohort study; Prospective observational cohort study. No study treatment was administered in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline	Participants who received prescription for COPD maintenance treatment were reported for following categories; Use the maintenance treatment, Long-Acting Muscarinic Antagonist (LAMA), Long-Acting Beta-Agonist (LABA), LABA/LAMA, inhaled corticosteroid (ICS)/LABA, Triple therapy (ICS/LABA/LAMA, Single Inhaler Triple Therapy [SITT]), Multiple Inhaler Triple Therapy (MITT), Theophylline, MITT or SITT, N-acetyl cysteine/carbocysteine. The measurement at Baseline visit (Day 1) was defined as Baseline. Participants may have received more than one COPD maintenance treatment. Hence, they may have counted in more than one category, so the total may not match to Number analyzed (N).	At Baseline (Day 1)
Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months	Participants who received prescription for COPD maintenance treatment were reported for following categories; Use the maintenance treatment, LAMA, LABA, LABA/LAMA, ICS/LABA, Triple therapy (ICS/LABA/LAMA, SITT), MITT, Theophylline, MITT or SITT, N-acetyl cysteine/carbocysteine. Participants may have received more than one COPD maintenance treatment. Hence, they may have counted in more than one category, so the total may not match to Number analyzed (N).	At 3 months
Number of Participants With Moderate Acute Exacerbation Requiring no Hospitalization by Each COPD Maintenance Treatment at Follow-up (Week 1)	Participants with moderate acute exacerbation requiring no hospitalization, who received prescription for COPD maintenance treatment were reported for following categories; Use the maintenance treatment, LAMA, LABA, LABA/LAMA, ICS/LABA, Triple therapy (ICS/LABA/LAMA, SITT), MITT, Theophylline, MITT or SITT, N-acetyl cysteine/carbocysteine. Participants may have received more than one COPD maintenance treatment. Hence, they may have counted in more than one category, so the total may not match to Number analyzed (N).	At Week 1
Number of Participants With Acute Exacerbation Requiring Hospitalization by Each COPD Maintenance Treatment at Discharge Follow-up (up to 28 Days)	Participants with acute exacerbation requiring hospitalization who received prescription for COPD maintenance treatment were reported for following categories; Use the maintenance treatment. LAMA, LABA, LABA/LAMA, ICS/LABA, Triple therapy (ICS/LABA/LAMA, SITT), MITT, Theophylline, MITT or SITT, N-acetyl cysteine/carbocysteine. Participants may have received more than one COPD maintenance treatment. Hence, they may have counted in more than one category, so the total may not match to Number analyzed (N).	At Discharge follow-up (up to 28 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Forced Expiratory Volume in One Minute (FEV1) at Baseline	FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one minute. FEV1 measurements were collected using a spirometer. The measurement at Baseline visit (Day 1) was defined as Baseline.	At Baseline (Day 1)
Number of Participants With History of Exacerbations in Within 1 Year Prior to Baseline	Number of participants with history of exacerbations were reported according to the usage of different patterns of maintenance therapy including LAMA, LABA, LABA/LAMA, ICS/LABA, Triple therapy (ICS/LABA/LAMA, SITT), MITT, Theophylline, MITT or SITT, N-acetyl cysteine/carbocysteine. The measurement at Baseline visit (Day 1) was defined as Baseline. Participants may have received more than one COPD maintenance treatment. Hence, they may have counted in more than one category, so the total may not match to Number analyzed (N).	Within 1 year prior to Baseline (Day 1) visit
Number of Participants With COPD Medication History	Number of participants with COPD medication history were reported for following categories; Use the maintenance treatment, LAMA, LABA, LABA/LAMA, ICS/LABA, Triple therapy (ICS/LABA/LAMA, SITT), MITT, Theophylline, MITT or SITT, N-acetyl cysteine/carbocysteine. The measurement at Baseline visit (Day 1) was defined as Baseline. Participants may have received more than one COPD maintenance treatment. Hence, they may have counted in more than one category, so the total may not match to Number analyzed (N).	At Pre-Baseline (Within 1 month before Baseline [Day 1] visit)
Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Scores by Historic Treatments at Indicated Time Point	The CAT is an 8-item unidimensional measure of health status impairment in participants with COPD. Participants are scored on eight items (cough, phlegm, chest tightness, breathlessness, activity limitation, confidence, sleep and energy) on a scale of 0 (no impact) to 5 (worst possible impact) depending on their impact. The sum of scores for each item gives the participant's impact score ranging from 0 (no impact) to 40 (worst possible impact). Higher score indicates worst possible impact. CAT score by historic treatments including LAMA, LABA, LABA/LAMA, ICS/LABA, Triple therapy (ICS/LABA/LAMA, SITT), MITT, Theophylline, MITT or SITT, N-acetyl cysteine/carbocysteine were reported. Participants may have received more than one COPD maintenance treatment. Hence, they may have counted in more than one category, so the total may not match to Number analyzed (N). Mean and standard deviation (SD) values of CAT score assessments at 3 months are reported.	At 3 months
Modified Medical Research Council (mMRC) Score by Historic Treatments at Indicated Time Point	The mMRC questionnaire predicts future mortality risk with mMRC. Participants are required to rate their disability due to shortness of breath on the 5-point mMRC scale ranging from 0 (no impact) to 4 (worst possible impact). Higher score indicates worst possible impact. The mMRC score by historic treatments including LAMA, LABA, LABA/LAMA, ICS/LABA, Triple therapy (ICS/LABA/LAMA, SITT), MITT, Theophylline, MITT or SITT, N-acetyl cysteine/carbocysteine were reported. Participants may have received more than one COPD maintenance treatment. Hence, they may have counted in more than one category, so the total may not match to Number analyzed (N). Mean and SD values of mMRC score assessments at 3 months are reported.	At 3 months
Number of Participants Requiring Hospitalization by Their Each Dyspnea, Eosinopenia, Consolidation, Acidemia and Atrial Fibrillation (DECAF) Risk Group	DECAF is a 7-point scale with a minimum score of 0 (better outcome) and a maximum score of 6 (worse outcome). Higher score indicates worst outcome. It is used for assessment of severity of COPD exacerbation measures Dyspnea, Eosinopenia, consolidation, acidemia and atrial fibrillation. Number of participants requiring hospitalization by their each DECAF risk groups Mild (0-1 score), moderate (2 score), severe (3-6 score) were summarized. Participants who did not provide scores were categorized under "Missing". The measurement at Baseline visit (Day 1) was defined as Baseline.	Baseline (Day 1)
Number of Participants With at Least One Co-morbidity	Number of participants with at least one co-morbidity were reported. Co-morbidities included Vascular disorders, Cardiac disorders, Respiratory, thoracic and mediastinal disorders, Metabolism and nutrition disorders, Infections and infestations, Gastrointestinal disorders, Reproductive system and breast disorders, Hepatobiliary disorders, Nervous system disorders, Renal and urinary disorders, Musculoskeletal and connective tissue disorders, Injury, poisoning and procedural complications, Psychiatric disorders, Endocrine disorders, Blood and lymphatic system disorders, Neoplasms benign, malignant and unspecified (including cysts and polyps), Skin and subcutaneous tissue disorders, Eye disorders, Investigations, General disorders and administration site conditions, Ear and labyrinth disorders, Congenital, familial and genetic disorders, Immune system disorders and Surgical and medical procedures).	Up to 3 months
Number of Participants by Their Socio-economic Characteristics	Questions were asked to participants to understand their following socio-economic factors associated with different patterns of COPD maintenance treatment;Education(No formal education, Elementary,Middle,High school-including vocational school, Bachelor's degree and above, Missing), Local permanent resident(No,Yes, Missing), Marriage condition(Married,Divorced/Separated,Widowed,Unmarried and Missing), With whom usually live(Live alone, With spouse, With one specific child, Take turns in different children's homes, Other relatives, Missing), National basic medical insurance (Insu.)(None,Government medical insu.,Urban employee medical insu., Urban resident medical insu., New cooperative medical insu., Urban and rural resident basic medical insu., Serious illness insu., Missing) and Commercial insu.(Yes,No,Missing). Participants may have provided more than one answers to questions. Hence, they may have counted in more than one category, so the total may not match to Number analyzed (N).	Baseline (Day 1)
Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points	The CAT is an 8-item unidimensional measure of health status impairment in participants with COPD. Participants are scored on eight items (cough, phlegm, chest tightness, breathlessness, activity limitation, confidence, sleep and energy) on a scale of 0 (no impact) to 5 (worst possible impact) depending on their impact. The sum of scores for each item gives the participant's impact score ranging from 0 (no impact) to 40 (worst possible impact). Higher score indicates worst possible impact. Number of participants by their CAT scores were reported (<=10, 11 to 20, 21 to 30, 31 to 40). Participants who did not provide scores were categorized under "Missing". The measurement at Baseline visit (Day 1) was defined as Baseline.	Baseline (Day 1), Week 1, Discharge follow-up (up to 28 days) and at 3 months
Number of Participants by Their Modified British Medical Research Council (mMRC) Score at Baseline	The mMRC questionnaire predicts future mortality risk with mMRC. Participants are required to rate their disability due to shortness of breath on the 5-point mMRC scale ranging from 0 (no impact) to 4 (worst possible impact). Higher score indicates worst possible impact. Number of participants by their mMRC scores (Scores 0, 1, 2, 3 and 4) were summarized. Participants who did not provide scores were categorized under "Missing". The measurement at Baseline visit (Day 1) was defined as Baseline.	At Baseline (Day 1)
Number of Participants Whose Prescribed Maintenance Treatment Was Stepped up, Stepped Down, Stopped, Switched, Remained the Same	Number of participants whose prescribed maintenance therapy was stepped up (adding another maintenance therapy), stepped down (withdraw any of the maintenance medication but kept the maintenance therapy), stopped (stop all maintenance therapy), switched (between LAMA/LABA and ICS/LABA) or remained the same were reported. Participants whose treatment was not categorized in any of the above, were reported under Missing.	Up to 3 months
Number of Participants Receiving COPD Maintenance Treatment at 3 Months	Number of participants receiving COPD maintenance treatment including LAMA, LABA/LAMA, ICS/LABA, Triple therapy (ICS/LABA/LAMA, SITT), MITT, Theophylline, MITT or SITT, N-acetyl cysteine/carbocysteine were reported. Participants may have received more than one COPD maintenance treatment. Hence, they may have counted in more than one category, so the total may not match to Number analyzed (N).	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): December 6, 2024
• Last Update Submitted That Met QC Criteria: October 24, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

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