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

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive

• Registration Number: NCT01424527
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2010-12
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Study First Submitted: 2011-07-07
• Study First Submitted QC: 2011-08-25
• Study First Posted: 2011-08-29
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-15
• Last Update Posted: 2017-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation coefficient of the Chronic obstructive pulmonary disease Assessment Test with St George's Respiratory Questionnaire	1 day	Correlation coefficient of the Chronic obstructive pulmonary disease Assessment Test with St George's Respiratory Questionnaire

Secondary Outcome Measures

Name	Time	Method
Correlation coefficient of the Chronic obstructive pulmonary disease Assessment Test with Medical Research Council Dyspnea Index	1 day	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.	1 day	Correlation coefficient of the Chronic obstructive pulmonary disease Assessment Test with Forced expiratory volume in 1 second

Trial Locations

Locations (1)

GSK Investigational Site; 🇰🇷 Seoul, Korea, Republic of