High Risk Populations Among COPD Patients in Japan

AstraZeneca

Status: Completed

Conditions: COPD

Study type: Observational

Funder types: Industry

Identifiers

NCT02413359

D589BR00033

Details and patient eligibility

About

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.

Full description

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

Enrollment: 1,016 patients

Sex: All

Ages: 40 to 150 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)