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

NCT ID: NCT01424527

Last Updated: 2017-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-04-30

Brief Summary

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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

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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.

Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Chronic Obstructive Pulmonary Disease

Males and females 40 years of age or older with a diagnosis of COPD

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Jung

Role: PRINCIPAL_INVESTIGATOR

Hallym University Medical Center

Locations

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GSK Investigational Site

Anyang-si, , South Korea

Site Status

GSK Investigational Site

Busan, , South Korea

Site Status

GSK Investigational Site

Gyung Gi Do, , South Korea

Site Status

GSK Investigational Site

Incheon, , South Korea

Site Status

GSK Investigational Site

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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115114

Identifier Type: -

Identifier Source: org_study_id

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