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.

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Key information

Conditions

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

Age range

40 year–150 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Takenaka Respiratory Clinic

Takarazuka, Hyōgo, 885-0845, Japan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

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)

Treatment and study plan

Primary outcomes

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.

Time frame: up to 2 month

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Research Study in Patients With COPD in High Risk Population in Japan: Proportion of Overlap Between COPD and Asthma, and the Relationship With COPD Exacerbation

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Apr 9, 2015
Registry last updated: Sep 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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