Pulmonary Disease, Chronic ObstructiveNCT03161587
Patient Characteristics and Treatment Modalities in COPD Patients in China
An observational study of Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 8 sites in China.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a complex disease characterized by multiple clinical manifestations as well as co-morbidities. While COPD subjects have traditionally been classified based solely on airflow limitation (forced expiratory volume in one second [FEV1]), a new classification system was… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- How many people
- 848 participants
- Where
- 8 sitesChina
- Study dates
- 31 May 2017to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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: The study population is comprised of COPD subjects who are being managed for their disease at outpatient clinics in tertiary hospitals. Subjects diagnosed with COPD for at least one year and in the stable state at enrolment with no exacerbation events in the preceding month are included.
Who may be able to join
- Aged 40 years and older
- A clinical diagnosis of COPD for at least one year: dyspnea, chronic cough or sputum production, and a history of exposure to risk factors for the disease and lung function test FEV1/ FVC <0.7(post bronchodilator)
- Out-patient
- Able to read, comprehend, and record information in Chinese
- A signed and dated written informed consent must be obtained from the subject prior to study participation Exclusion criteria
- Current exacerbation or an exacerbation within the preceding one month
Show all 9Show fewer
- Other unstable diseases which could influence CAT and lung function results (judged by physicians)
- A medical diagnosis of active tuberculosis, cystic fibrosis, any other pulmonary condition, lung cancer, or hypereosinophilic syndromes (HES)
- Currently participating in another COPD clinical study which provides the subject investigational medication and/or disease management
Who cannot join
None listed.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
GSK Investigational Site
Beijing, 100032
GSK Investigational Site
Changsha, Hunan, 410011
GSK Investigational Site
Chengdu, Sichuan, 610041
GSK Investigational Site
Guangzhou, Guangdong, 510120
GSK Investigational Site
Hohhot, Inner Mongolia, 010017
GSK Investigational Site
Shanghai, 200025
GSK Investigational Site
Xiamen, Fujian, 361004
GSK Investigational Site
Zhengzhou
About this study
Official title: Patient Characteristics and Treatment Modalities in COPD Patients Assessed by GOLD2016 : a Cross-Sectional Study in China
Chronic obstructive pulmonary disease (COPD) is a complex disease characterized by multiple clinical manifestations as well as co-morbidities. While COPD subjects have traditionally been classified based solely on airflow limitation (forced expiratory volume in one second [FEV1]), a new classification system was introduced in the year of 2011 by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) that recommended subjects with COPD should be classified based on a combination of airflow limitation, disease impact (determined by symptom burden and activity limitation) and history of exacerbation. This approach results in the classification of subjects in four groups: A (low risk, less symptoms), B (low risk, more symptoms), C (high risk, less symptoms), and D (high risk, more symptoms). This classification system was further refined in year 2013, specifically around the history of exacerbation definition, where having ≥1 exacerbation leading to hospital admission in preceding year was added as a criteria for classification into the "high risk" C or D groups. Further, in the year 2016, there was a refinement of the disease impact criteria that suggest the use of the COPD Assessment Test (CAT) score (over the Modified British Medical Research Council Dyspnea Scale [mMRC] score) as the preferred tool to determine classification as "more symptoms" or "less symptoms". This study aims to understand subject characteristics and current treatment modalities in different groups classified by GOLD 2016 comprehensive classification system and to understand if current treatment choice is concordant with the GOLD recommendations in real life clinical practice in China tertiary hospitals. It will provide a useful point-in-time description of COPD subject characteristics and current treatment modalities in real life clinical practice in China.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- FEV1, COPD, CAT, treatment modality, FVC, GOLD 2016, mMRC
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with COPD | Subjects with diagnosis of COPD at least one year, visiting outpatient clinics in tertiary hospitals in China and in stable state at enrolment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects classified into each of the GOLD 2016 comprehensive classification system groups
Subjects will be classified into groups A-D according to GOLD 2016 comprehensive classification system. Symptoms will be assessed with the CAT scale to determine if the subject belongs to the boxes of side-Less Symptoms (CAT \<10) or side-More Symptoms (CAT ≥10).
Risk of exacerbations will be assessed to determine if the subject belongs to the lower part of the box-Low Risk or the upper part of the box-High Risk.
Spirometry will be used to determine the GOLD grade of airflow limitation (GOLD 1 and GOLD 2 categories indicate Low Risk, while GOLD 3 and GOLD 4 indicate High Risk).
Measured: Day 1
To determine the demographic characteristics for each GOLD 2016 group
Subject's height, weight and waistline will be measured. Body Mass Index will be calculated by height and weight, and smoking status will be reported and recorded.
Measured: Day 1
To determine co-morbid diseases
Cardiovascular diseases (ischemic heart disease, heart failure, atrial fibrillation, hypertension), diabetes, hyperlipidemia, anxiety, depression, gastroesophageal reflux disease (GERD), obstructive sleep apnea syndrome (OSAS), bronchiectasis, allergic airway disease be reported and recorded.
Measured: Day 1
To assess the disease severity by CAT score
Symptom assessment will be done based on CAT score. The CAT is a validated, short and simple subject completed questionnaire which has been developed for use in routine clinical practice to measure the health status of subjects with COPD. Subjects are scored on eight items (cough, phlegm, chest tightness, breathlessness, activity limitation, confidence, sleep and energy) on a scale of 0-5 depending on their impact. The sum of scores for each item gives the subject's impact score ranging from 0 (no impact) to 40 (worst possible impact). Subjects will be stratified as score < 10 and ≥10.
Measured: Day 1
To assess the disease severity by lung function
Subjects will undergo a lung function test (FEV1 and Forced Vital Capacity [FVC]) during the study visit if they do not have record of a lung function test report in last 6 months.
Measured: Day 1
No of subjects with exacerbation history and hospitalization for exacerbation in preceding year
An exacerbation of COPD is an acute event characterized by a worsening of the subject's respiratory symptoms that is beyond normal day-to-day variations and leads to a change in medication. Subject's exacerbation history in the preceding year will be measured and recorded on the subject note
Measured: Day 1
Secondary outcomes (1)
Number of subjects treated in concordance with first and alternative choice treatments recommended for each GOLD 2016 grade based on current maintenance treatment
GOLD 2016 A-D group's current maintenance treatment will be regarded as concordant with "Recommended First Choice" if subject's current maintenance treatment is one of "recommended first choice" for his/her group. By the same rule, a subject's current maintenance treatment will be regarded as concordant with "alternative choice" if his/her current maintenance is one of "alternative choice" for his/her group.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start31 May 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 848 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
- NCT03161587
- Sponsor's protocol ID
- 207136
- Status last verified
- Jun 2019
- First submitted
- 18 May 2017
- Last updated
- 28 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Characteristics and Treatment Modalities in COPD Patients Assessed by GOLD2016 : a Cross-Sectional Study in China
- ClinicalTrials.gov ID
- NCT03161587
- Acronym / sponsor ID
- 207136
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- FEV1, COPD, CAT, treatment modality, FVC, GOLD 2016, mMRC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 848 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 31 May 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 22 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic obstructive pulmonary disease (COPD) is a complex disease characterized by multiple clinical manifestations as well as co-morbidities. While COPD subjects have traditionally been classified based solely on airflow limitation (forced expiratory volume in one second [FEV1]), a new classification system was introduced in the year of 2011 by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) that recommended subjects with COPD should be classified based on a combination of airflow limitation, disease impact (determined by symptom burden and activity limitation) and history of exacerbation. This approach results in the classification of subjects in four groups: A (low risk, less symptoms), B (low risk, more symptoms), C (high risk, less symptoms), and D (high risk, more symptoms). This classification system was further refined in year 2013, specifically around the history of exacerbation definition, where having ≥1 exacerbation leading to hospital admission in preceding year was added as a criteria for classification into the "high risk" C or D groups. Further, in the year 2016, there was a refinement of the disease impact criteria that suggest the use of the COPD Assessment Test (CAT) score (over the Modified British Medical Research Council Dyspnea Scale [mMRC] score) as the preferred tool to determine classification as "more symptoms" or "less symptoms". This study aims to understand subject characteristics and current treatment modalities in different groups classified by GOLD 2016 comprehensive classification system and to understand if current treatment choice is concordant with the GOLD recommendations in real life clinical practice in China tertiary hospitals. It will provide a useful point-in-time description of COPD subject characteristics and current treatment modalities in real life clinical practice in China.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with COPD | – | –Subjects with diagnosis of COPD at least one year, visiting outpatient clinics in tertiary hospitals in China and in stable state at enrolment. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is comprised of COPD subjects who are being managed for their disease at outpatient clinics in tertiary hospitals. Subjects diagnosed with COPD for at least one year and in the stable state at enrolment with no exacerbation events in the preceding month are included.
Key inclusion criteria (9 listed)
- Aged 40 years and older
- A clinical diagnosis of COPD for at least one year: dyspnea, chronic cough or sputum production, and a history of exposure to risk factors for the disease and lung function test FEV1/ FVC <0.7(post bronchodilator)
- Out-patient
- Able to read, comprehend, and record information in Chinese
- A signed and dated written informed consent must be obtained from the subject prior to study participation Exclusion criteria
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of subjects classified into each of the GOLD 2016 comprehensive classification system groups
Time frame: Day 1
Subjects will be classified into groups A-D according to GOLD 2016 comprehensive classification system. Symptoms will be assessed with the CAT scale to determine if the subject belongs to the boxes of side-Less Symptoms (CAT \<10) or side-More Symptoms (CAT ≥10). Risk of exacerbations will be assessed to determine if the subject belongs to the lower part of the box-Low Risk or the upper part of the box-High Risk. Spirometry will be used to determine the GOLD grade of airflow limitation (GOLD 1 and GOLD 2 categories indicate Low Risk, while GOLD 3 and GOLD 4 indicate High Risk).
To determine the demographic characteristics for each GOLD 2016 group
Time frame: Day 1
Subject's height, weight and waistline will be measured. Body Mass Index will be calculated by height and weight, and smoking status will be reported and recorded.
To determine co-morbid diseases
Time frame: Day 1
Cardiovascular diseases (ischemic heart disease, heart failure, atrial fibrillation, hypertension), diabetes, hyperlipidemia, anxiety, depression, gastroesophageal reflux disease (GERD), obstructive sleep apnea syndrome (OSAS), bronchiectasis, allergic airway disease be reported and recorded.
To assess the disease severity by CAT score
Time frame: Day 1
Symptom assessment will be done based on CAT score. The CAT is a validated, short and simple subject completed questionnaire which has been developed for use in routine clinical practice to measure the health status of subjects with COPD. Subjects are scored on eight items (cough, phlegm, chest tightness, breathlessness, activity limitation, confidence, sleep and energy) on a scale of 0-5 depending on their impact. The sum of scores for each item gives the subject's impact score ranging from 0 (no impact) to 40 (worst possible impact). Subjects will be stratified as score < 10 and ≥10.
To assess the disease severity by lung function
Time frame: Day 1
Subjects will undergo a lung function test (FEV1 and Forced Vital Capacity [FVC]) during the study visit if they do not have record of a lung function test report in last 6 months.
No of subjects with exacerbation history and hospitalization for exacerbation in preceding year
Time frame: Day 1
An exacerbation of COPD is an acute event characterized by a worsening of the subject's respiratory symptoms that is beyond normal day-to-day variations and leads to a change in medication. Subject's exacerbation history in the preceding year will be measured and recorded on the subject note
1 secondary outcome
Number of subjects treated in concordance with first and alternative choice treatments recommended for each GOLD 2016 grade based on current maintenance treatment
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2019.
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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
8 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 8 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 9 inclusion and 0 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 28 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 subjects classified into each of the GOLD 2016 comprehensive classification system groups (time frame: Day 1). The study lists 6 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 28 Jun 2019.