COPDEPOCHNCT01419379
This is a Multicenter, Prospective and Retrospective and Descriptive Epidemiology Study in Patients With Chronic Obstructive Pulmonary Disease (COPD) in Korea
An observational study of COPD, run by Takeda at 14 sites in South Korea.
Trial summary
This study is designed as a multicenter, prospective and retrospective and descriptive epidemiology study. This study is planned to evaluate 2 years of exacerbation in COPD patients and to investigate correlation of COPD disease progress and its exacerbation. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- How many people
- 1,118 participants
- Where
- 14 sitesSouth Korea
- Study dates
- Jul 2011to Jan 2013
- 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: Patients with COPD
Who may be able to join
- Over 40 years old
- Patient with at least 1 year of medical history of COPD as defined by GOLD criteria
- Patient with having past 1 year medical record at the investigational site
- Patient who signed Informed Consent Form
Who cannot join
- Patients who are currently involved in any other interventional studies or possible to be involved for the next 1 year
- Patients currently diagnosed with cancer
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
South Korea14 sites
Nycomed Investigational Site
Busan
Nycomed Investigational Site
Chungcheongnam-do
Nycomed Investigational Site
Daegu
Nycomed Investigational Site
Daejeon
Nycomed Investigational Site
Gangwon-do
Nycomed Investigational Site
Gwangju
Nycomed Investigational Site
Gyeongbuk
Nycomed Investigational Site
Gyeonggi-do
Nycomed Investigational Site
Gyeongsangnam-do
Nycomed Investigational Site
Incheon
Nycomed Investigational Site
Jeollanam-do
Nycomed Investigational Site
Jeonbuk
Nycomed Investigational Site
Seoul
Nycomed Investigational Site
Ulsan
About this study
Official title: Epidemiologic Review and Prospective Observation of COPD and Health in Korea
This study is designed as a multicenter, prospective and retrospective and descriptive epidemiology study.
This study is planned to evaluate 2 years of exacerbation in COPD patients and to investigate correlation of COPD disease progress and its exacerbation.
Read more
This study is designed with 6 months of subject enrollments, 12 months of retrospective study, and 12 months of prospective study. Hence, each patient will be participating in the study for 12 months, while the actual data collections from the patients will take a total of 24 months.
The statistical analysis of this study will be done twice, at the completion of 1 year retrospective data collection and at the completion of next 1 year follow-up.
The 1st statistical analysis of retrospective study includes exacerbation rate, duration of hospitalization for exacerbation and lung function test for the past 1 year from the enrollment and comorbidities, COPD assessment (CAT) and COPD medication at the enrollment will be analyzed.
The 2nd statistical analysis of prospective 1-year follow-up includes changes in exacerbation rates, comparison of lung function test results, comorbidities, COPD assessments (CAT) and COPD medications of retrospective and prospective studies for the 2 years as well as mortality rate.
- Conditions
- COPD
- Keywords
- COPD exacerbation rate
- 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 |
|---|---|---|
| 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate exacerbation rate in patients suffering from COPD
A total of 2 years of data will be evaluated based on annual evaluations:
- 1 year-before the enrollment (past 1 year) and
- 1 year-after the enrollment (1 year from the enrollment)
Measured: 24 months
Secondary outcomes (5)
To investigate comorbidities of COPD
Measured: At screening and after 12 months
To determine airflow obstruction through lung function test
Lung function test data will be collected at the time of enrollment, 1 year before the enrollment (if available) and 1 year after the enrollment.
For lung function data, the closest ones to the evaluation date among those obtained from ±3 months will be used.
Items to be collected are pre/post bronchodilator FEV1, FVC, FEV1/FVC.
Measured: 24 months
To assess COPD (through CAT)
Patients will complete CAT (COPD Assessment Test) questionnaire.
Measured: At screening and after 12 months
To know the current use of medications for COPD treatment
Medications for COPD treatment at the time of enrollment will be investigated.
Measured: At screening and after 12 months
To investigate mortality of COPD patients for 1 year period
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by TakedaThe 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
- Cohort
- Enrolment
- 1,118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01419379
- Sponsor's protocol ID
- RO-2455-401-KR
- Other IDs
- U1111-1142-0154
- Acronym
- EPOCH
- Status last verified
- Apr 2013
- First submitted
- 17 Aug 2011
- Last updated
- 18 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiologic Review and Prospective Observation of COPD and Health in Korea
- ClinicalTrials.gov ID
- NCT01419379
- Acronym / sponsor ID
- EPOCH / RO-2455-401-KR
- Conditions
- COPD
- Keywords
- COPD exacerbation rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,118 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 18 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 study is designed as a multicenter, prospective and retrospective and descriptive epidemiology study.
This study is planned to evaluate 2 years of exacerbation in COPD patients and to investigate correlation of COPD disease progress and its exacerbation.
This study is designed with 6 months of subject enrollments, 12 months of retrospective study, and 12 months of prospective study. Hence, each patient will be participating in the study for 12 months, while the actual data collections from the patients will take a total of 24 months.
The statistical analysis of this study will be done twice, at the completion of 1 year retrospective data collection and at the completion of next 1 year follow-up.
The 1st statistical analysis of retrospective study includes exacerbation rate, duration of hospitalization for exacerbation and lung function test for the past 1 year from the enrollment and comorbidities, COPD assessment (CAT) and COPD medication at the enrollment will be analyzed.
The 2nd statistical analysis of prospective 1-year follow-up includes changes in exacerbation rates, comparison of lung function test results, comorbidities, COPD assessments (CAT) and COPD medications of retrospective and prospective studies for the 2 years as well as mortality rate.
Study design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with COPD
Key inclusion criteria (4 listed)
- Over 40 years old
- Patient with at least 1 year of medical history of COPD as defined by GOLD criteria
- Patient with having past 1 year medical record at the investigational site
- Patient who signed Informed Consent Form
Key exclusion criteria (2 listed)
- Patients who are currently involved in any other interventional studies or possible to be involved for the next 1 year
- Patients currently diagnosed with cancer
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
To investigate exacerbation rate in patients suffering from COPD
Time frame: 24 months
A total of 2 years of data will be evaluated based on annual evaluations: * 1 year-before the enrollment (past 1 year) and * 1 year-after the enrollment (1 year from the enrollment)
5 secondary outcomes
To investigate comorbidities of COPD
Time frame: At screening and after 12 months
To determine airflow obstruction through lung function test
Time frame: 24 months
To assess COPD (through CAT)
Time frame: At screening and after 12 months
To know the current use of medications for COPD treatment
Time frame: At screening and after 12 months
To investigate mortality of COPD patients for 1 year period
Time frame: 12 months
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 18 Apr 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by Takeda at 14 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 4 inclusion and 2 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 18 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
To investigate exacerbation rate in patients suffering from COPD (time frame: 24 months). 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 18 Apr 2013.