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.
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
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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- 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 group | Role | What they receive |
|---|---|---|
| Cohort 1: Participants with stable disease | Not described Receives: Other: Prospective observational cohort study | |
| Cohort 2: Participants with moderate acute exacerbation not requiring hospitalization | Not described Receives: Other: Prospective observational cohort study | |
| Cohort 3: Participants requiring hospitalization for an acute exacerbation | Not described Receives: Other: Prospective observational cohort study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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)
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)
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
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)
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
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
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)
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
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)
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
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)
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
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.
- First posted21 Apr 2021
- Study start27 Apr 2021
- Primary completion3 Nov 2022
- Study completion6 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COPD Disease Burden, Patient Characteristics, Maintenance Treatment Patterns and Factors Influencing Treatment Decisions in China Tier 2 and Tier 3 Hospitals
- ClinicalTrials.gov ID
- NCT04853238
- Acronym / sponsor ID
- 213550
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Chronic obstructive pulmonary disease, China, Disease burden, Maintenance treatment patterns
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,507 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 3 Nov 2022 (actual)
- Study completion
- 6 Feb 2023 (actual)
- First posted
- 21 Apr 2021 (actual)
- Results
- Posted 6 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prospective observational cohort studyProspective observational cohort study. No study treatment was administered in this study. | Other | 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 |
Primary outcome
Number of Participants Who Received COPD Prescription for Maintenance Treatment at Baseline
Time frame: At Baseline (Day 1)
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).
Number of Participants Who Received COPD Prescription for Maintenance Treatment at 3 Months
Time frame: 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).
Number of Participants With Moderate Acute Exacerbation Requiring no Hospitalization by Each COPD Maintenance Treatment at Follow-up (Week 1)
Time frame: At 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).
Number of Participants With Acute Exacerbation Requiring Hospitalization by Each COPD Maintenance Treatment at Discharge Follow-up (up to 28 Days)
Time frame: 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).
12 secondary outcomes
Mean Forced Expiratory Volume in One Minute (FEV1) at Baseline
Time frame: At Baseline (Day 1)
Number of Participants With History of Exacerbations in Within 1 Year Prior to Baseline
Time frame: Within 1 year prior to Baseline (Day 1) visit
Number of Participants With COPD Medication History
Time frame: 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
Time frame: At 3 months
Modified Medical Research Council (mMRC) Score by Historic Treatments at Indicated Time Point
Time frame: At 3 months
Number of Participants Requiring Hospitalization by Their Each Dyspnea, Eosinopenia, Consolidation, Acidemia and Atrial Fibrillation (DECAF) Risk Group
Time frame: Baseline (Day 1)
Number of Participants With at Least One Co-morbidity
Time frame: Up to 3 months
Number of Participants by Their Socio-economic Characteristics
Time frame: Baseline (Day 1)
Number of Participants by Their COPD Assessment Test (CAT) Scores at Indicated Time Points
Time frame: 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
Time frame: At Baseline (Day 1)
Number of Participants Whose Prescribed Maintenance Treatment Was Stepped up, Stepped Down, Stopped, Switched, Remained the Same
Time frame: Up to 3 months
Number of Participants Receiving COPD Maintenance Treatment at 3 Months
Time frame: At 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
39 sites in 1 country: see every site and its status.
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.