Korean Chronic Obstructive Pulmonary Disease(COPD) Assessment Test Validation Study

Overview

This is a cross-sectional validation study, designed to evaluate the discriminative validity of the Chronic Obstructive Pulmonary Disease Assessment Test translated in a local language in patients with Chronic Obstructive Pulmonary Disease.

Full Title of Study: “Validation of the New COPD Assessment Test Translated Into Korean in Patients With Chronic Obstructive Pulmonary Disease”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: April 2011

Detailed Description

The Chronic obstructive pulmonary disease Assessment Test is a new questionnaire that has been developed recently to improve communication between doctors and patients. It is known to have good relationship with other measures of quality of life. For the wider application to practice, it has been translated into a local language in many countries.

Arms, Groups and Cohorts

  • Chronic Obstructive Pulmonary Disease
    • Males and females 40 years of age or older with a diagnosis of COPD

Clinical Trial Outcome Measures

Primary Measures

  • Correlation coefficient of the Chronic obstructive pulmonary disease Assessment Test with St George’s Respiratory Questionnaire
    • Time Frame: 1 day
    • Correlation coefficient of the Chronic obstructive pulmonary disease Assessment Test with St George’s Respiratory Questionnaire

Secondary Measures

  • Correlation coefficient of the Chronic obstructive pulmonary disease Assessment Test with Medical Research Council Dyspnea Index
    • Time Frame: 1 day
    • Correlation coefficient of the Chronic obstructive pulmonary disease Assessment Test with Medical Research Council Dyspnea Index
  • Correlation coefficient of the Chronic obstructive pulmonary disease Assessment Test with Forced expiratory volume in 1 second value.
    • Time Frame: 1 day
    • Correlation coefficient of the Chronic obstructive pulmonary disease Assessment Test with Forced expiratory volume in 1 second

Participating in This Clinical Trial

Inclusion Criteria

Subjects eligible for enrolment in the study must meet all of the following criteria:

1. Type of subject: Outpatients

2. Informed consent: Subjects must give their signed and dated written informed consent to participate.

3. Gender: Male or Female

4. Age: 40 years of age or older at a clinic visit

5. COPD diagnosis: Subjects with an established diagnosis of COPD in the past 6 months or before.

6. Tobacco use: Smokers or ex-smokers with a smoking history of more than 10 pack years.

Exclusion Criteria

1. Asthma: Subjects with a current diagnosis of asthma. Subjects with a prior history of asthma are eligible if COPD is the current diagnosis.

2. Lung diseases: Subjects with current active respiratory disorders other than COPD, e.g. lung cancer, tuberculosis.

3. Non-compliance: Unable to complete questionnaires

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • GlaxoSmithKline
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • GSK Clinical Trials, Study Director, GlaxoSmithKline
    • Jung, Principal Investigator, Hallym University Medical Center

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