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Completed

NCT Number: NCT01424527

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

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site, Anyang-si, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Correlation coefficient of the Chronic obstructive pulmonary disease Assessment Test with St George's Respiratory Questionnaire

    Time frame: 1 day

    Correlation coefficient of the Chronic obstructive pulmonary disease Assessment Test with St George's Respiratory Questionnaire

Secondary outcomes

  1. Correlation coefficient of the Chronic obstructive pulmonary disease Assessment Test with Medical Research Council Dyspnea Index

    Time frame: 1 day

    Correlation coefficient of the Chronic obstructive pulmonary disease Assessment Test with Medical Research Council Dyspnea Index

  2. Correlation coefficient of the Chronic obstructive pulmonary disease Assessment Test with Forced expiratory volume in 1 second value.

    Time frame: 1 day

    Correlation coefficient of the Chronic obstructive pulmonary disease Assessment Test with Forced expiratory volume in 1 second

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Validation of the New COPD Assessment Test Translated Into Korean in Patients With Chronic Obstructive Pulmonary Disease

Acronym: CAT

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 29, 2011
Registry last updated
May 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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