We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Seoul National University Airway Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02527486
Recruitment Status : Recruiting
First Posted : August 19, 2015
Last Update Posted : August 19, 2015
Sponsor:
Information provided by (Responsible Party):
Chang-Hoon Lee, Seoul National University Hospital

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease
Chronic Obstructive Pulmonary Disease (COPD) Asthma Asthma With Chronic Obstructive Pulmonary Disease Bronchiectasis Inactive Tuberculosis of Lung Chronic Obstructive Airway Disease

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Airway Registry for Chronic Airway Diseases
Study Start Date : September 2011
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2031

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
No predefined subgroups


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Death (time to death) [ Time Frame: upto 20 years ]
    death from any cause, death from COPD-specific cause, death from CVD, malignancy


Secondary Outcome Measures :
  1. post-bronchodilator FEV1 change rates [ Time Frame: upto 20 years (at least 3 years) ]

Other Outcome Measures:
  1. 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

  2. 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


Biospecimen Retention:   Samples With DNA
Blood (whole blood, serum, plasma, buffy coat) Urine

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
COPD Asthma ACOS Bronchiectasis TB-destroyed lung Other chronic airway diseases
Criteria

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:

-

Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02527486


Contacts
Layout table for location contacts
Contact: Chang-Hoon Lee, M.D. 82-2-2072-4743 kauri670@gmail.com

Locations
Layout table for location information
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Gyeonggi-Do, Korea, Republic of, 463-707
Contact: Ho-Il Yoon, M.D.       dextro70@gmail.com   
Principal Investigator: Ho-Il Yoon, M.D.         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Principal Investigator: Chang-Hoon Lee, M.D.         
Seoul Metropolitan Government-Seoul National University Boramae Medical Center Active, not recruiting
Seoul, Korea, Republic of, 156-707
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Layout table for investigator information
Study Chair: Chul-Gyu Yoo, M.D. Seoul National University Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Chang-Hoon Lee, Associate professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02527486    
Other Study ID Numbers: AW_registry
First Posted: August 19, 2015    Key Record Dates
Last Update Posted: August 19, 2015
Last Verified: August 2015
Keywords provided by Chang-Hoon Lee, Seoul National University Hospital:
COPD
Asthma
ACOS
Bronchiectasis
Additional relevant MeSH terms:
Layout table for MeSH terms
Tuberculosis
Latent Tuberculosis
Tuberculosis, Pulmonary
Asthma
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
 Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Latent Infection
Respiratory Tract Infections