. 2020 Dec 23;38(2):1168–1184. doi: 10.1007/s12325-020-01573-x

Table 2.

Inclusion and exclusion criteria

Inclusion criteria	Exclusion criteria
1. Patients who provided written informed consent for study participation 2. Patients aged ≥ 40 years 3. Patients with lung function (FEV₁/FVC) < 70% after inhalation of a bronchodilator within the past year or at the time of registration 4. Patients who fulfill one of the following criteria: smoking history (≥ 10 pack-years) or equivalent air pollution exposure (including passive smoking) at the time of registration; presence of a low attenuation area showing emphysematous change on chest computed tomography imaging as assessed by the investigator based on the most recent scan within the past year; lung diffusion impairment (defined as %D_LCO < 80% or %D_LCO/V_A < 80%) assessed within the past year 5. Outpatients who were able to regularly visit the study sites in Japan at least once per year	1. Patients participating in an interventional study within 8 weeks prior to registration 2. Patients who experienced an exacerbation of COPD^a or asthma^b within the last 8 weeks 3. Patients with a condition that could not be distinguished from COPD or asthma at the time of obtaining consent (diffuse panoramic bronchitis, congenital sinus bronchial syndrome, obstructive panbronchitis, bronchiectasis, pulmonary tuberculosis, pneumoconiosis, lymphangiomyomatosis, interstitial lung disease, lung cancer, vocal fold dysfunction, intratracheal tumor, tracheal softening, bronchial tuberculosis, pulmonary thromboembolism, congestive heart failure). However, patients with certain diseases could be registered if remission or stable disease was confirmed by the physician (laryngitis, epiglottitis, airway foreign body, cough induced by a drug such as an angiotensin converting enzyme inhibitor, spontaneous pneumothorax, hyperventilation syndrome, and psychogenic cough) 4. Any patient who could not comply with study procedures or was otherwise determined by the investigator to be ineligible

Inclusion criteria

Exclusion criteria

1. Patients who provided written informed consent for study participation

2. Patients aged ≥ 40 years

3. Patients with lung function (FEV₁/FVC) < 70% after inhalation of a bronchodilator within the past year or at the time of registration

4. Patients who fulfill one of the following criteria: smoking history (≥ 10 pack-years) or equivalent air pollution exposure (including passive smoking) at the time of registration; presence of a low attenuation area showing emphysematous change on chest computed tomography imaging as assessed by the investigator based on the most recent scan within the past year; lung diffusion impairment (defined as %D_LCO < 80% or %D_LCO/V_A < 80%) assessed within the past year

5. Outpatients who were able to regularly visit the study sites in Japan at least once per year

1. Patients participating in an interventional study within 8 weeks prior to registration

2. Patients who experienced an exacerbation of COPD^a or asthma^b within the last 8 weeks

3. Patients with a condition that could not be distinguished from COPD or asthma at the time of obtaining consent (diffuse panoramic bronchitis, congenital sinus bronchial syndrome, obstructive panbronchitis, bronchiectasis, pulmonary tuberculosis, pneumoconiosis, lymphangiomyomatosis, interstitial lung disease, lung cancer, vocal fold dysfunction, intratracheal tumor, tracheal softening, bronchial tuberculosis, pulmonary thromboembolism, congestive heart failure). However, patients with certain diseases could be registered if remission or stable disease was confirmed by the physician (laryngitis, epiglottitis, airway foreign body, cough induced by a drug such as an angiotensin converting enzyme inhibitor, spontaneous pneumothorax, hyperventilation syndrome, and psychogenic cough)

4. Any patient who could not comply with study procedures or was otherwise determined by the investigator to be ineligible

COPD chronic obstructive pulmonary disease, D_LCO diffusion capacity for carbon monoxide, FEV₁ forced expiratory volume in one second, FVC forced vital capacity, V_A alveolar volume

^aCOPD exacerbation was defined as the need to change stable treatment due to the observation of increasing symptoms (shortness of breath, cough, and sputum and discomfort or strange sensation in the chest), with the exception of symptoms relevant to other preexisting diseases (e.g., cardiac failure, pneumothorax, pulmonary thromboembolism)

^bAsthma exacerbation was defined as the development of paroxysmal/variable symptoms of cough, sputum, wheezing, and dyspnea induced by factors such as respiratory infection