Have you or your loved ones been diagnosed with chronic obstructive pulmonary disease copd?
You may be eligible to participate in a chronic obstructive pulmonary disease copd clinical trial.
Have you or your loved ones been diagnosed with chronic obstructive pulmonary disease copd? You may be eligible to participate in a chronic obstructive pulmonary disease copd clinical trial.
What is a clinical trial? Is participating in a clinical trial right for you? Learn more
Chronic Obstructive Pulmonary Disease COPD Clinical Trial in Beijing
Have you or your loved ones been diagnosed with chronic obstructive pulmonary disease copd?
You may be eligible to participate in a chronic obstructive pulmonary disease copd clinical trial.
Have you or your loved ones been diagnosed with chronic obstructive pulmonary disease copd? You may be eligible to participate in a chronic obstructive pulmonary disease copd clinical trial.
Completed
Male & Female
All ages
This is a multi-centre, prospective, observational study to realize the current situation of COPD patients in China. About 5000 COPD patients will be enrolled from 50 participating sites around China and followed up for one year. During this study, patients will undergo clinical assessments and receive medical care as determined by their treating physician.
Details for the study
Population
Approximately 5000 patients with COPD will be enrolled from 50 tertiary and secondary hospitals in six geographic regions around China in order to recruit a nationally representative study population from 2017 Q2 to 2018 Q2.
Brief Title
Realize the Current Situation of COPD Patients in China
Official Title
REALizing and Improving Management of Stable COPD in China--A Multi-centre, Prospective, Observational Study to Realize the Current Situation of COPD Patients in China.
Brief Summary
This is a multi-centre, prospective, observational study to realize the current situation of <br /> COPD patients in China. About 5000 COPD patients will be enrolled from 50 participating sites <br /> around China and followed up for one year. During this study, patients will undergo clinical <br /> assessments and receive medical care as determined by their treating physician.
Detailed Description
This is a multi-centre, prospective, observational study. This study aims to observe the
general situation in clinical practice, and the evolution and outcome of current usual care
of COPD in China.This is an observational study. It will be carried out under routine
clinical practice and the treatment will be determined by patients' treating physicians.
Information about exposure to treatments as part of routine care will be collected (dose,
frequency and duration).
A multi-stage, stratified and cluster sampling method will be used to select a nationally
representative sample from the tertiary and secondary hospitals with respiratory department
in six geographic regions around China as the study sites. Approximately 5000 patients with
COPD will be enrolled from 50 selected study sites in order to recruit a nationally
representative study population and followed up for one year.
Outcome Measures
Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.
Primary
The mean change in mMRC
The mean change in mMRC results after one year from baseline. Modified Medical Research Council Questionnaire (mMRC) will be assessed according to the severity of breathlessness as below: Grade 0 I only get breathless with strenuous exercise Grade 1 I get short of breath when hurrying on the level or walking up a slight hill Grade 2 I walk slower than people of the same age on the level because of breathlessness, or I have to stop for breath when walking on my own pace on the level Grade 3 I stop for breath after walking about 100 meters or after a few minutes on the level Grade 4 I am too breathless to leave the house or I am breathless when dressing or undressing
Primary
The proportion of hospitalized patients by different severity of COPD patients by airway limitation / by A/B/C/D at baseline
The proportion of hospitalized patients due to the COPD exacerbations by different severity of COPD patients by airway limitation / by A/B/C/D at baseline within one year according to GOLD 2016.
Primary
The mean rate of COPD exacerbations by different severity of COPD patients by airway limitation / by A/B/C/D at baseline.
The mean rate of COPD exacerbations (acute exacerbation number per patient per year) by different severity of COPD patients by airway limitation / by A/B/C/D at baseline according to GOLD 2016.
Primary
The mean change in COPD-Q
The mean change in COPD patients' cognition questionnaire (COPD-Q) total scores after one year from baseline. COPD knowledge Questionnaire (COPD-Q) total score will be derived by summing up the scores from 13 items evaluating patients knowledge and understanding to COPD including 8 forward items: 1point (true), 0 point (false or not sure); 5 reverse items: 1 point (false), 0 point (true or not sure). Then get the total scores.
Primary
The mean change in CAT
The mean change in CAT total scores after one year from baseline; COPD assessment test (CAT) total score will be derived by summing up the score of all items. Total Scores range 0-40.The COPD influence on patients: 1 stage (mild): 0-10 points; 2 stage (moderate): 11-20 points; 3 stage (severe):21-30 points; 4 stage (very severe):31-40 points.
Primary
The mean reduction value of available FEV1
The mean reduction value of available FEV1 after one year from baseline
Primary
The distribution of different severity of COPD exacerbations
The distribution will be measured by percentage of patient on each level of severity of COPD exacerbations (mild: requiring an increase in rescue medication≥ 3 puffs / day for at least 2 consecutive days; moderate: requiring systemic glucocorticosteroids and/or antibiotics; severe: hospitalization, emergency room visit or leading to death), the calculation will be based on non-missing data.
Primary
The proportion of hospitalized patients
The proportion of hospitalized patients due to the COPD exacerbations within one year；
Primary
The mean rate of COPD exacerbations
The mean rate of COPD exacerbations (acute exacerbation number per patient per year).
Primary
The mean reduction value of available FEV1 by different severity of COPD by airway limitation / by A/B/C/D patients after one year from baseline
The mean reduction value of available FEV1 by different severity of COPD by airway limitation / by A/B/C/D patients according to GOLD 2016 after one year from baseline
Secondary
Distribution of stable COPD medications by drug class according to the severity by airway limitation / by A/B/C/D patients
The distribution will be measured by the percentage of stable COPD medications by drug class (ICS[inhaled corticosteroid], LABA[long-acting beta2-agonist], ICS/LABA[combination long-acting beta2-agonists plus corticosteroids in one inhaler], SABA[short-acting beta2-agonist], SAMA[short-acting muscarinic antagonist], SABA/SAMA [combination short-acting beta2-agonist plus anticholinergic], LAMA[long-acting muscarinic antagonist], methylxanthines, mucolytic, traditional Chinese medicine and others [antibiotics, systemic corticosteroids, vaccines, antioxidant agents, etc]) according to the severity by airway limitation / by A/B/C/D patients at baseline and after one year. The calculation will be based on non-missing data.
Secondary
Distribution of medications for COPD exacerbations by drug class including hospital prescribed and pharmacy bought
The distribution will be measured by the percentage of patient on each kind of medications for COPD exacerbations by drug (short-acting bronchodilators, corticosteroids, antibiotics and others) including hospital prescribed and pharmacy bought. The calculation will be based on non-missing data.
Secondary
Distribution of non-drug treatments
The distribution will be measured by the percentage of patient on each kind of non-drug treatments (health education, smoking cessation, exercise of respiratory function and vaccine injection) during the study. The calculation will be based on non-missing data.
Secondary
Patients drug compliance
Patients drug compliance (actual drug taken days/actually prescribed days, and actual drug taken dosage/actually prescribed dosage)
Secondary
Distribution of stable COPD frequency by drug class according to the severity by airway limitation / by A/B/C/D patients at baseline and after one year.
The distribution will be measured by the percentage of patient on each level of stable COPD frequency by drug class ( same as above) according to the severity by airway limitation / by A/B/C/D patients at baseline and after one year. The calculation will be based on non-missing data.
Secondary
Distribution of prescribed stable COPD medications by drug class at each usual visit.
The distribution will be measured by the percentage of patient on each kind of prescribed stable COPD medications by drug class (ICS[inhaled corticosteroid], LABA[long-acting beta2-agonist], ICS/LABA[combination long-acting beta2-agonists plus corticosteroids in one inhaler], SABA[short-acting beta2-agonist], SAMA[short-acting muscarinic antagonist], SABA/SAMA [combination short-acting beta2-agonist plus anticholinergic], LAMA[long-acting muscarinic antagonist], methylxanthines, mucolytic, traditional Chinese medicine and others [antibiotics, systemic corticosteroids, vaccines, antioxidant agents, etc]) on each usual care visit. The calculation will be based on non-missing data.
Secondary
Distribution of stable COPD dosage by drug class according to the severity by airway limitation / by A/B/C/D patients at baseline and after one year.
The distribution will be measured by the percentage of patient on each kind of stable COPD dosage by drug class according to the severity by airway limitation / by A/B/C/D patients at baseline and after one year. The calculation will be based on non-missing data.
Secondary
Distribution of stable COPD medications in mono in total population by drug class
The distribution will be measured by the percentage of patient on each kind of stable COPD medications in mono in total population by drug class (ICS[inhaled corticosteroid], LABA[long-acting beta2-agonist], ICS/LABA[combination long-acting beta2-agonists plus corticosteroids in one inhaler], SABA[short-acting beta2-agonist], SAMA[short-acting muscarinic antagonist], SABA/SAMA [combination short-acting beta2-agonist plus anticholinergic], LAMA[long-acting muscarinic antagonist], methylxanthines, mucolytic, traditional Chinese medicine and others [antibiotics, systemic corticosteroids, vaccines, antioxidant agents, etc]) at baseline and after one year. The calculation will be based on non-missing data.
Secondary
Patients visit compliance
Patients visit compliance (the mean usual care visit times per patient per year, and the dropout rate at each visit including V0, V1 and TC visits)
Secondary
Mean total direct COPD cost
Mean total direct COPD cost of the whole year per patient including the stable COPD management cost (medications and non-drug treatments) and the COPD exacerbations cost.
Secondary
The distribution of different severity of COPD patients
The distribution will be measured by the percentage of patient on each level of severity of COPD patients by airway limitation / by A/B/C/D patients at baseline and after one year. The calculation will be based on non-missing data.
Secondary
Distribution of stable COPD medications in combination in total population by drug class
The distribution will be measured by the percentage of patient on each kind of stable COPD medications in combination in total population by drug class (ICS[inhaled corticosteroid], LABA[long-acting beta2-agonist], ICS/LABA[combination long-acting beta2-agonists plus corticosteroids in one inhaler], SABA[short-acting beta2-agonist], SAMA[short-acting muscarinic antagonist], SABA/SAMA [combination short-acting beta2-agonist plus anticholinergic], LAMA[long-acting muscarinic antagonist], methylxanthines, mucolytic, traditional Chinese medicine and others [antibiotics, systemic corticosteroids, vaccines, antioxidant agents, etc]) at baseline and after one year. The calculation will be based on non-missing data.
Study Criteria
Inclusion Criteria:
- Outpatients, more than 40 years old
- Clinically diagnosed as COPD (the patients are clinically diagnosed as COPD based on
chronic cough, sputum, wheeze and a history of exposure to harmful factors, and
confirmed by spirometry(FEV1/FVC<0.7, post-bronchodilator according to GOLD 2016)
- Sign (or their legally-acceptable representatives must sign) and date the informed
consent form indicating that they understand the purpose of and procedure required for
the study and are willing to participate in the study.
Exclusion Criteria:
- Participated in any interventional clinical trial during the last 30 days
- With acute exacerbation within 4 weeks before enrolment
- Not suitable for study observation judged by investigators.