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

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ClinicalTrials.gov Identifier: NCT01424527
Recruitment Status : Completed
First Posted : August 29, 2011
Last Update Posted : May 16, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
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 or disease
Pulmonary Disease, Chronic Obstructive

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.

Study Type : Observational
Actual Enrollment : 100 participants
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
Study Start Date : December 2010
Primary Completion Date : April 2011
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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


Biospecimen Retention:   None Retained
none retained


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01424527     History of Changes
Other Study ID Numbers: 115114
First Posted: August 29, 2011    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: May 2017

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

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