NCT01419379

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,118

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

April 18, 2013

Status Verified

April 1, 2013

Enrollment Period

1.5 years

First QC Date

August 17, 2011

Last Update Submit

April 16, 2013

Conditions

COPD

Keywords

COPD exacerbation rate

Outcome Measures

Primary Outcomes (1)

  • 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)

    24 months

Secondary Outcomes (5)

  • To investigate comorbidities of COPD

    At screening and after 12 months

  • To determine airflow obstruction through lung function test

    24 months

  • To assess COPD (through CAT)

    At screening and after 12 months

  • To know the current use of medications for COPD treatment

    At screening and after 12 months

  • To investigate mortality of COPD patients for 1 year period

    12 months

Study Arms (1)

1

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with COPD

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Nycomed Investigational Site

Busan, South Korea

Location

Nycomed Investigational Site

Chungcheongnam-do, South Korea

Location

Nycomed Investigational Site

Daegu, South Korea

Location

Nycomed Investigational Site

Daejeon, South Korea

Location

Nycomed Investigational Site

Gangwon-do, South Korea

Location

Nycomed Investigational Site

Gwangju, South Korea

Location

Nycomed Investigational Site

Gyeongbuk, South Korea

Location

Nycomed Investigational Site

Gyeonggi-do, South Korea

Location

Nycomed Investigational Site

Gyeongsangnam-do, South Korea

Location

Nycomed Investigational Site

Incheon, South Korea

Location

Nycomed Investigational Site

Jeollanam-do, South Korea

Location

Nycomed Investigational Site

Jeonbuk, South Korea

Location

Nycomed Investigational Site

Seoul, South Korea

Location

Nycomed Investigational Site

Ulsan, South Korea

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2011

First Posted

August 18, 2011

Study Start

July 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

April 18, 2013

Record last verified: 2013-04

Locations

KR(14)