Clinical trial NCT01419379: This is a Multicenter, Prospective and Retrospective and Descriptive Epidemiology Study in Patients With Chronic Obstructive Pulmonary Disease (COPD) in Korea
Official title: Epidemiologic Review and Prospective Observation of COPD and Health in Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Keywords: COPD exacerbation rate
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2011-08-18
Enrollment: 1118
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with COPD

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

1. Over 40 years old
2. Patient with at least 1 year of medical history of COPD as defined by GOLD criteria
3. Patient with having past 1 year medical record at the investigational site
4. Patient who signed Informed Consent Form

Exclusion Criteria:

1. Patients who are currently involved in any other interventional studies or possible to be involved for the next 1 year
2. Patients currently diagnosed with cancer

Primary outcomes:
measure: To investigate exacerbation rate in patients suffering from COPD
timeFrame: 24 months
Secondary outcomes:
measure: To investigate comorbidities of COPD
timeFrame: At screening and after 12 months
measure: To determine airflow obstruction through lung function test
timeFrame: 24 months
measure: To assess COPD (through CAT)
timeFrame: At screening and after 12 months
measure: To know the current use of medications for COPD treatment
timeFrame: At screening and after 12 months
measure: To investigate mortality of COPD patients for 1 year period
timeFrame: 12 months
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Nycomed Investigational Site
city: Chungcheongnam-do
country: Korea, Republic of
facility: Nycomed Investigational Site
city: Daegu
country: Korea, Republic of
facility: Nycomed Investigational Site
city: Daejon
country: Korea, Republic of
facility: Nycomed Investigational Site
city: Gangwon-do
country: Korea, Republic of
facility: Nycomed Investigational Site
city: Gwangju
country: Korea, Republic of
facility: Nycomed Investigational Site
city: Gyeongbuk
country: Korea, Republic of
facility: Nycomed Investigational Site
city: Gyeonggi-do
country: Korea, Republic of
facility: Nycomed Investigational Site
city: Gyeongsangnam-do
country: Korea, Republic of
facility: Nycomed Investigational Site
city: Incheon
country: Korea, Republic of
facility: Nycomed Investigational Site
city: Jeollanam-do
country: Korea, Republic of
facility: Nycomed Investigational Site
city: Jeonbuk
country: Korea, Republic of
facility: Nycomed Investigational Site
city: Seoul
country: Korea, Republic of
facility: Nycomed Investigational Site
city: Ulsan
country: Korea, Republic of
facility: Nycomed Investigational Site
Study officials:
References: