Pulmonary Disease, Chronic ObstructiveCATNCT01424527
Korean Chronic Obstructive Pulmonary Disease(COPD) Assessment Test Validation Study
An observational study of Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 5 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- How many people
- 100 participants
- Where
- 5 sitesSouth Korea
- Study dates
- Dec 2010to Apr 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
GSK Investigational Site
Anyang-si, 431-070
GSK Investigational Site
Busan
GSK Investigational Site
Gyung Gi Do
GSK Investigational Site
Incheon
GSK Investigational Site
Seoul
About this study
Official title: Validation of the New COPD Assessment Test Translated Into Korean in Patients With Chronic Obstructive Pulmonary Disease
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.
Read the 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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Chronic Obstructive Pulmonary Disease(COPD), COPD Assessment Test(CAT)
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Obstructive Pulmonary Disease | Males and females 40 years of age or older with a diagnosis of COPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (2)
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 Medical Research Council Dyspnea Index
Measured: 1 day
Correlation coefficient of the Chronic obstructive pulmonary disease Assessment Test with Forced expiratory volume in 1 second value.
Correlation coefficient of the Chronic obstructive pulmonary disease Assessment Test with Forced expiratory volume in 1 second
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2011 (estimated)
- Study startDec 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKlineJung, Principal investigator, Hallym University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01424527
- Sponsor's protocol ID
- 115114
- Acronym
- CAT
- Status last verified
- May 2017
- First submitted
- 7 Jul 2011
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the New COPD Assessment Test Translated Into Korean in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01424527
- Acronym / sponsor ID
- CAT / 115114
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Chronic Obstructive Pulmonary Disease(COPD), COPD Assessment Test(CAT)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 29 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Obstructive Pulmonary Disease | – | –Males and females 40 years of age or older with a diagnosis of COPD |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
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 Forced expiratory volume in 1 second value.
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Jung principal investigator
Hallym University Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 5 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation coefficient of the Chronic obstructive pulmonary disease Assessment Test with St George's Respiratory Questionnaire (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2017.