Trial record 1 of 3919 for:
Lung Diseases, Obstructive
Korean Chronic Obstructive Pulmonary Disease(COPD) Assessment Test Validation Study (CAT)
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01424527
First received: July 7, 2011
Last updated: October 13, 2011
Last verified: October 2011
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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:
- Type of subject: Outpatients
- Informed consent: Subjects must give their signed and dated written informed consent to participate.
- Gender: Male or Female
- Age: 40 years of age or older at a clinic visit
- COPD diagnosis: Subjects with an established diagnosis of COPD in the past 6 months or before.
- Tobacco use: Smokers or ex-smokers with a smoking history of more than 10 pack years.
Exclusion Criteria:
- Asthma: Subjects with a current diagnosis of asthma. Subjects with a prior history of asthma are eligible if COPD is the current diagnosis.
- Lung diseases: Subjects with current active respiratory disorders other than COPD, e.g. lung cancer, tuberculosis.
- Non-compliance: Unable to complete questionnaires
Contacts and Locations
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 Respiration Disorders Pulmonary Disease, Chronic Obstructive |
Lung Diseases, Obstructive Disease Attributes Pathologic Processes Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 23, 2013