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Pulmonary Disease, Chronic ObstructiveNCT04853238

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

An observational study of Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 39 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
Prospective observational cohort study
How many people
1,507 participants
Where
39 sitesChina
Study dates
27 Apr 2021to 6 Feb 2023
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants with COPD either in stable state or with an acute exacerbation, in Tier 2 and 3 hospitals in China.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

39 sites in 1 country.

39 sites in 1 country

China39 sites
  • GSK Investigational Site

    Beijing, 100029

  • GSK Investigational Site

    Beijing, 102399

  • GSK Investigational Site

    Cangzhou, 061001

  • GSK Investigational Site

    Chengdu, 610000

  • GSK Investigational Site

    Chongqing, 400000

  • GSK Investigational Site

    Chongqing, 400010

  • GSK Investigational Site

    Hangzhou, 311202

  • GSK Investigational Site

    Hefei, 230001

  • GSK Investigational Site

    Huizhou, Guangdong, 516000

  • GSK Investigational Site

    Jiangmen, Guangdong, 529100

  • GSK Investigational Site

    Jinan, Shandong, 250014

  • GSK Investigational Site

    Jinan, Shandong, 250101

  • GSK Investigational Site

    Jingzhou, 434020

  • GSK Investigational Site

    Luoyang, 471003

  • GSK Investigational Site

    Nanchang, 330006

  • GSK Investigational Site

    Nanning, Guangxi, 530021

  • GSK Investigational Site

    Nanning, 530405

  • GSK Investigational Site

    Nanyang, 473000

  • GSK Investigational Site

    Pingdingshan, 462500

  • GSK Investigational Site

    Shanghai, 200000

  • GSK Investigational Site

    Shanghai, 200032

  • GSK Investigational Site

    Shanxi, 037008

  • GSK Investigational Site

    Shaoguan, Guangdong, 512600

  • GSK Investigational Site

    Shenyang, Liaoning, 110000

  • GSK Investigational Site

    Shenyang, 110024

  • GSK Investigational Site

    Shenzhen, Guangdong, 518020

  • GSK Investigational Site

    Taiyuan, Shanxi, 030006

  • GSK Investigational Site

    Tianjin, 300052

  • GSK Investigational Site

    Tianjin, 300480

  • GSK Investigational Site

    Wuhan, Hubei, 430014

  • GSK Investigational Site

    Wuhan, 430015

  • GSK Investigational Site

    Xi'an, Shaanxi, 710000

  • GSK Investigational Site

    Xi'an, 710600

  • GSK Investigational Site

    Xiangtan, 411100

  • GSK Investigational Site

    Yibin, 629000

  • GSK Investigational Site

    Yibin, 644000

  • GSK Investigational Site

    Yinchuan, Ningxia, 750001

  • GSK Investigational Site

    Zhejiang, Zhejiang, 314399

  • GSK Investigational Site

    Zhengzhou, 450000

Other trials in China

About this study

Official title: 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.

Being tested
Prospective observational cohort study
Keywords
Chronic obstructive pulmonary disease, China, Disease burden, Maintenance treatment patterns
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prospective observational cohort studyOther

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

Study groups in NCT04853238
Study groupRoleWhat they receive
Cohort 1: Participants with stable diseaseNot described
Receives: Other: Prospective observational cohort study
Cohort 2: Participants with moderate acute exacerbation not requiring hospitalizationNot described
Receives: Other: Prospective observational cohort study
Cohort 3: Participants requiring hospitalization for an acute exacerbationNot described
Receives: Other: Prospective observational cohort study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: At Baseline (Day 1)

  2. 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).

    Measured: At 3 months

  3. 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).

    Measured: At Week 1

  4. 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).

    Measured: At Discharge follow-up (up to 28 days)

Secondary outcomes (12)
  1. 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.

    Measured: At Baseline (Day 1)

  2. 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).

    Measured: Within 1 year prior to Baseline (Day 1) visit

  3. 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).

    Measured: At Pre-Baseline (Within 1 month before Baseline [Day 1] visit)

  4. 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.

    Measured: At 3 months

  5. 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.

    Measured: At 3 months

  6. 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.

    Measured: Baseline (Day 1)

  7. 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).

    Measured: Up to 3 months

  8. 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).

    Measured: Baseline (Day 1)

  9. 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.

    Measured: Baseline (Day 1), Week 1, Discharge follow-up (up to 28 days) and at 3 months

  10. 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.

    Measured: At Baseline (Day 1)

  11. 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.

    Measured: Up to 3 months

  12. 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).

    Measured: At 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2021
  2. Study start27 Apr 2021
  3. Primary completion3 Nov 2022
  4. Study completion6 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,507 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04853238
Sponsor's protocol ID
213550
Status last verified
Oct 2024
First submitted
16 Apr 2021
Last updated
6 Dec 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 39 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline (time frame: At Baseline (Day 1)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.

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