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High Risk Populations Among COPD Patients in Japan

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT02413359
Collaborator
(none)
1,016
Enrollment
1
Location
2
Duration (Months)
507
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1016 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official 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
    Study Start Date :
    May 1, 2015
    Actual Primary Completion Date :
    Jul 1, 2015
    Actual Study Completion Date :
    Jul 1, 2015

    Outcome Measures

    Primary Outcome Measures

    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

    Criteria

    Ages Eligible for Study:
    40 Years to 150 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Takenaka Respiratory Clinic Takarazuka Hyougo Japan 885-0845

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Study Director: Atsuhi Yoshida, AstraZeneca, Japan - Medical Affairs

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT02413359
    Other Study ID Numbers:
    • D589BR00033
    First Posted:
    Apr 9, 2015
    Last Update Posted:
    Sep 21, 2016
    Last Verified:
    Sep 1, 2016

    Study Results

    No Results Posted as of Sep 21, 2016