High Risk Populations Among COPD Patients in Japan
High Risk Populations Among COPD Patients in Japan
The patients with complications of COPD and asthma have features mixed with two diseases,
 COPD and asthma. Therefore, the outcomes are worsened if the patients with COPD have symptoms
 overlapped with asthma, however, no sufficient data exist in Japan for estimating the
 prevalence of ACOS in patients with COPD. The primary objective of this NIS is to clarify the
 proportion of ACOS defined by GINA and GOLD in patients with COPD. The main secondary
 objectives are To explore the features of history of COPD exacerbations, symptoms,
 eosinophilic inflammation and patient background in patients with ACOS, to clarify the
 history of COPD exacerbations in patients with COPD, to evaluate the degrees of eosinophilic
 inflammation of the respiratory tract in patients with COPD and to evaluate the symptoms in
 patients with COPD. This is a cross-sectional study targeting COPD patients receiving
 outpatient treatment and follow-up by physicians in Japan. FSI is scheduled as 2Q 2015 and
 DBL would be locked by 3Q 2015.
Study Site(s), number of subjects planned Number of study sites planned for this research
 study (scheduled) 60 (undetermined) Number of subjects planned for this research study
 (scheduled) 1,100 patients
Inclusion criteria

 -  Patients with a diagnosis of COPD (FEV1/FVC<0.7 confirmed based on the past medical
 records)

 -  Patients aged 40 years and over at the diagnosis of COPD

 -  Outpatient

 -  10 or more pack-years of current or former smokers

 -  Patients who have traceable medical records of COPD (including the results of
 spirometry) going back more than a year

 -  Patients who meet any of the following two criteria

 1. Patients who have medical records of the results of spirometry at more than two
 different time points excluding the time point of COPD exacerbations* for the
 past 3 years

 2. Patients who can provide the results of reversibility testing for respiratory
 tract

 -  Patients who give written informed consent regarding the participation in this study

 Exclusion criteria

 -  Patients currently with COPD exacerbations

 -  Patients who currently enroll in the other interventional study including clinical
 trials

 -  Patients who concurrently develop or have a history of lung cancer

 -  Patients who are disabled to understand the study procedure or answer the
 questionnaire (i.e. due to the history of alcohol or drug abuse)