Last updated: 11/03/2018 17:36:43
Korean Chronic Obstructive Pulmonary Disease(COPD) Assessment Test validation studyCAT
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Validation of the new COPD Assessment Test translated into Korean in patients with Chronic Obstructive Pulmonary Disease
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Correlation coefficient of the Chronic obstructive pulmonary disease Assessment Test with St George’s Respiratory Questionnaire
Timeframe: 1 day
Secondary outcomes:
Correlation coefficient of the Chronic obstructive pulmonary disease Assessment Test with Medical Research Council Dyspnea Index
Timeframe: 1 day
Correlation coefficient of the Chronic obstructive pulmonary disease Assessment Test with Forced expiratory volume in 1 second value.
Timeframe: 1 day
Interventions:
Not applicable
Enrollment:
100
Primary completion date:
Not applicable
Observational study model:
Case-Only
Time perspective:
Cross-Sectional
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
Not applicable
Collaborators
Not applicable
Study date(s)
December 2010 to March 2011
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
- Subjects eligible for enrolment in the study must meet all of the following criteria:
- 1.Type of subject: Outpatients
- 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.
Inclusion and exclusion 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
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2011-05-03
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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