High Risk Populations Among COPD Patients in Japan

NCT02413359 | Completed

• 1 other identifier: D589BR00033
• Study Type: observational
• Target: 1,016
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• Proportion of ACOS defined by The Global Initiative for Asthma (GINA) and The Global Initiative for Chronic Obstructive Lung Disease (GOLD) in patients with COPD receiving outpatient treatment and follow-up by physicians in Japan.

  up to 2 month

Eligibility Criteria

• Age: 40 Years - 150 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of COPD

You may qualify if:

• 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
• 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
• 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
• Patients who can provide the results of reversibility testing for respiratory tract
• Patients who give written informed consent regarding the participation in this study

You may not qualify if:

• 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)

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Takenaka Respiratory Clinic

Takarazuka, Hyōgo, 885-0845, Japan

Location

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Atsuhi Yoshida, AstraZeneca

  Japan - Medical Affairs

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2015
• First Posted: April 9, 2015
• Study Start: May 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: September 21, 2016

Record last verified: 2016-09

Locations

JP (1)