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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01424527
First received: July 7, 2011
Last updated: October 13, 2011
Last verified: October 2011
  Purpose

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.


Condition
Pulmonary Disease, Chronic Obstructive

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Validation of the New COPD Assessment Test Translated Into Korean in Patients With Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Correlation coefficient of the Chronic obstructive pulmonary disease Assessment Test with St George's Respiratory Questionnaire [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Correlation coefficient of the Chronic obstructive pulmonary disease Assessment Test with St George's Respiratory Questionnaire


Secondary Outcome Measures:
  • Correlation coefficient of the Chronic obstructive pulmonary disease Assessment Test with Medical Research Council Dyspnea Index [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Correlation coefficient of the Chronic obstructive pulmonary disease Assessment Test with Forced expiratory volume in 1 second


Biospecimen Retention:   None Retained

none retained


Enrollment: 100
Study Start Date: December 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Chronic Obstructive Pulmonary Disease
Males and females 40 years of age or older with a diagnosis of COPD

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Males and females 40 years of age or older with a diagnosis of COPD are eligible. Subjects will complete questionnaires and perform spirometry at a single visit.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01424527

Locations
Korea, Republic of
GSK Investigational Site
Anyang-Si, Korea, Republic of, 431-070
GSK Investigational Site
Busan-si, Korea, Republic of
GSK Investigational Site
Gyung Gi Do, Korea, Republic of
GSK Investigational Site
Incheon, Korea, Republic of
GSK Investigational Site
Seoul, Korea, Republic of
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
Principal Investigator: Jung Hallym University Medical Center
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01424527     History of Changes
Other Study ID Numbers: 115114
Study First Received: July 7, 2011
Last Updated: October 13, 2011
Health Authority: Korea: Institutional Review Board

Keywords provided by GlaxoSmithKline:
Chronic Obstructive Pulmonary Disease(COPD)
COPD Assessment Test(CAT)

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 18, 2014