Seoul National University Airway Registry

August 17, 2015 updated by: Chang-Hoon Lee, Seoul National University Hospital

Airway Registry for Chronic Airway Diseases

This is a multicenter, prospective observational cohort study, in which patients with chronic airway diseases including chronic obstructive pulmonary disease(COPD), asthma, asthma-COPD overlap syndrome (ACOS) will be recruited.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Recruiting
        • Seoul National University Hospital
        • Principal Investigator:
          • Chang-Hoon Lee, M.D.
      • Seoul, Korea, Republic of, 156-707
        • Active, not recruiting
        • Seoul Metropolitan Government-Seoul National University Boramae Medical Center
    • Gyeonggi-Do
      • Seongnam, Gyeonggi-Do, Korea, Republic of, 463-707
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
        • Principal Investigator:
          • Ho-Il Yoon, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

COPD Asthma ACOS Bronchiectasis TB-destroyed lung Other chronic airway diseases

Description

COPD

Inclusion Criteria:

  • Postbronchodilator FEV1/FVC < 0.7 AND chronic respiratory symptom

Exclusion Criteria:

-

Asthma

Inclusion Criteria:

  • Never smoker or <5PY of smoking history AND Recurrent episodes of asthma symptoms (wheezing, dyspnea, chest tightness, cough) AND (either Positive BDR OR positive metacholine/mannitol/exercise provocation test)

Exclusion Criteria:

-

ACOS

Inclusion Criteria:

  • COPD AND Asthma (regardless of smoking status)

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
No predefined subgroups

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death (time to death)
Time Frame: upto 20 years
death from any cause, death from COPD-specific cause, death from CVD, malignancy
upto 20 years

Secondary Outcome Measures

Outcome Measure
Time Frame
post-bronchodilator FEV1 change rates
Time Frame: upto 20 years (at least 3 years)
upto 20 years (at least 3 years)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to 1st exacerbation (definition of exacerbation is described below)
Time Frame: upto 20 years
Definition of exacerbation: Airway disease symptom aggravation requiring either (1) Use of antibiotics or steroid, or (2) visiting ER or hospitalization
upto 20 years
Annual rate of exacerbation (definition of exacerbation is described below)
Time Frame: upto 20 years
Definition of exacerbation: Airway disease symptom aggravation requiring either (1) Use of antibiotics or steroid, or (2) visiting ER or hospitalization
upto 20 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Study Chair: Chul-Gyu Yoo, M.D., Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2031

Study Registration Dates

First Submitted

December 19, 2014

First Submitted That Met QC Criteria

August 17, 2015

First Posted (Estimate)

August 19, 2015

Study Record Updates

Last Update Posted (Estimate)

August 19, 2015

Last Update Submitted That Met QC Criteria

August 17, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AW_registry

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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