Realize the Current Situation of COPD Patients in China (REAL)

The mean rate of COPD exacerbations

The mean rate of COPD exacerbations (acute exacerbation number per patient per year).

The proportion of hospitalized patients

The proportion of hospitalized patients due to the COPD exacerbations within one year；

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.

The mean reduction value of available FEV1

The mean reduction value of available FEV1 after one year from baseline

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.

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

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.

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.

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.

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

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.

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.

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.

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.

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.

Patients drug compliance

Patients drug compliance (actual drug taken days/actually prescribed days, and actual drug taken dosage/actually prescribed dosage)

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.

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.

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.

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.

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)

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.