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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

July 7, 2011
October 13, 2011
December 2010
April 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01424527 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Korean Chronic Obstructive Pulmonary Disease(COPD) Assessment Test Validation Study
Validation of the New COPD Assessment Test Translated Into Korean in Patients With Chronic Obstructive Pulmonary Disease

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
Retention:   None Retained
Description:

none retained

Non-Probability Sample

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.

Pulmonary Disease, Chronic Obstructive
Not Provided
Chronic Obstructive Pulmonary Disease
Males and females 40 years of age or older with a diagnosis of COPD
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01424527
115114
No
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
Principal Investigator: Jung Hallym University Medical Center
GlaxoSmithKline
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP