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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1142-0154 | Registry Identifier | WHO |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 |
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| Measure | Description | Time Frame |
|---|---|---|
| To investigate exacerbation rate in patients suffering from COPD | A total of 2 years of data will be evaluated based on annual evaluations:
| 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate comorbidities of COPD | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with COPD
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nycomed Investigational Site | Busan | South Korea | ||||
| Nycomed Investigational Site |
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| 24 months |
| To assess COPD (through CAT) | Patients will complete CAT (COPD Assessment Test) questionnaire. | 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. | At screening and after 12 months |
| To investigate mortality of COPD patients for 1 year period | 12 months |
| Chungcheongnam-do |
| South Korea |
| Nycomed Investigational Site | Daegu | South Korea |
| Nycomed Investigational Site | Daejeon | South Korea |
| Nycomed Investigational Site | Gangwon-do | South Korea |
| Nycomed Investigational Site | Gwangju | South Korea |
| Nycomed Investigational Site | Gyeongbuk | South Korea |
| Nycomed Investigational Site | Gyeonggi-do | South Korea |
| Nycomed Investigational Site | Gyeongsangnam-do | South Korea |
| Nycomed Investigational Site | Incheon | South Korea |
| Nycomed Investigational Site | Jeollanam-do | South Korea |
| Nycomed Investigational Site | Jeonbuk | South Korea |
| Nycomed Investigational Site | Seoul | South Korea |
| Nycomed Investigational Site | Ulsan | South Korea |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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