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

NCT04853238 | Completed Results

• 1 other identifier: 213550
• Study Type: observational
• Target: 1,507
• Locations: 1 country
• Sites: 39

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Chronic obstructive pulmonary disease; China; Disease burden; Maintenance treatment patterns

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (12)

• Mean Forced Expiratory Volume in One Minute (FEV1) at Baseline

  At Baseline (Day 1)

• Number of Participants With History of Exacerbations in Within 1 Year Prior to Baseline

  Within 1 year prior to Baseline (Day 1) visit

• Number of Participants With COPD Medication History

  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

  At 3 months

• Modified Medical Research Council (mMRC) Score by Historic Treatments at Indicated Time Point

  At 3 months

Study Arms (3)

Cohort 1: Participants with stable disease

Other: Prospective observational cohort study

Cohort 2: Participants with moderate acute exacerbation not requiring hospitalization

Other: Prospective observational cohort study

Cohort 3: Participants requiring hospitalization for an acute exacerbation

Other: Prospective observational cohort study

Interventions

Prospective observational cohort study OTHER

Prospective observational cohort study. No study treatment was administered in this study.

Cohort 1: Participants with stable disease; Cohort 2: Participants with moderate acute exacerbation not requiring hospitalization; Cohort 3: Participants requiring hospitalization for an acute exacerbation

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (39)

GSK Investigational Site

Huizhou, Guangdong, 516000, China

Location

GSK Investigational Site

Jiangmen, Guangdong, 529100, China

Location

GSK Investigational Site

Shaoguan, Guangdong, 512600, China

Location

GSK Investigational Site

Shenzhen, Guangdong, 518020, China

Location

GSK Investigational Site

Nanning, Guangxi, 530021, China

Location

GSK Investigational Site

Wuhan, Hubei, 430014, China

Location

GSK Investigational Site

Shenyang, Liaoning, 110000, China

Location

GSK Investigational Site

Yinchuan, Ningxia, 750001, China

Location

GSK Investigational Site

Xi'an, Shaanxi, 710000, China

Location

GSK Investigational Site

Jinan, Shandong, 250014, China

Location

GSK Investigational Site

Jinan, Shandong, 250101, China

Location

GSK Investigational Site

Taiyuan, Shanxi, 030006, China

Location

GSK Investigational Site

Zhejiang, Zhejiang, 314399, China

Location

GSK Investigational Site

Beijing, 100029, China

Location

GSK Investigational Site

Beijing, 102399, China

Location

GSK Investigational Site

Cangzhou, 061001, China

Location

GSK Investigational Site

Chengdu, 610000, China

Location

GSK Investigational Site

Chongqing, 400000, China

Location

GSK Investigational Site

Chongqing, 400010, China

Location

GSK Investigational Site

Hangzhou, 311202, China

Location

GSK Investigational Site

Hefei, 230001, China

Location

GSK Investigational Site

Jingzhou, 434020, China

Location

GSK Investigational Site

Luoyang, 471003, China

Location

GSK Investigational Site

Nanchang, 330006, China

Location

GSK Investigational Site

Nanning, 530405, China

Location

GSK Investigational Site

Nanyang, 473000, China

Location

GSK Investigational Site

Pingdingshan, 462500, China

Location

GSK Investigational Site

Shanghai, 200000, China

Location

GSK Investigational Site

Shanghai, 200032, China

Location

GSK Investigational Site

Shanxi, 037008, China

Location

GSK Investigational Site

Shenyang, 110024, China

Location

GSK Investigational Site

Tianjin, 300052, China

Location

GSK Investigational Site

Tianjin, 300480, China

Location

GSK Investigational Site

Wuhan, 430015, China

Location

GSK Investigational Site

Xi'an, 710600, China

Location

GSK Investigational Site

Xiangtan, 411100, China

Location

GSK Investigational Site

Yibin, 629000, China

Location

GSK Investigational Site

Yibin, 644000, China

Location

GSK Investigational Site

Zhengzhou, 450000, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 21, 2021
• Study Start: April 27, 2021
• Primary Completion: November 3, 2022
• Study Completion: February 6, 2023
• Last Updated: December 6, 2024
• Results First Posted: December 6, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (39)