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

NCT01424527 | Completed

• 1 other identifier: 115114
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 5

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Chronic Obstructive Pulmonary Disease(COPD); COPD Assessment Test(CAT)

Outcome Measures

Primary Outcomes (1)

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

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

  1 day

Secondary Outcomes (2)

• 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 Forced expiratory volume in 1 second value.

  1 day

Study Arms (1)

Chronic Obstructive Pulmonary Disease

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

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (5)

GSK Investigational Site

Anyang-si, 431-070, South Korea

Location

GSK Investigational Site

Busan, South Korea

Location

GSK Investigational Site

Gyung Gi Do, South Korea

Location

GSK Investigational Site

Incheon, South Korea

Location

GSK Investigational Site

Seoul, South Korea

Location

Biospecimen

Retention: NONE RETAINED

none retained

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

• Jung

  Hallym University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2011
• First Posted: August 29, 2011
• Study Start: December 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: May 16, 2017

Record last verified: 2017-05

Locations

KR (5)