Seoul National University Airway Registry

Asthma Clinical Trial

Official title:

Airway Registry for Chronic Airway Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02527486
• Other study ID #: AW_registry
• Status: Recruiting
• Phase: N/A
• First received: December 19, 2014
• Last updated: August 17, 2015
• Start date: September 2011
• Est. completion date: December 2031

Study information

• Verified date: August 2015
• Source: Seoul National University Hospital
• Contact: Chang-Hoon Lee, M.D.
• Phone: 82-2-2072-4743
• Email: kauri670[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 2031
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma
• Asthma With Chronic Obstructive Pulmonary Disease
• Bronchiectasis
• Chronic Obstructive Airway Disease
• Chronic Obstructive Pulmonary Disease (COPD)
• Inactive Tuberculosis of Lung
• Latent Tuberculosis
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Tuberculosis
• Tuberculosis, Pulmonary

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-Do
Korea, Republic of	Seoul Metropolitan Government-Seoul National University Boramae Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to 1st exacerbation (definition of exacerbation is described below)	Definition of exacerbation: Airway disease symptom aggravation requiring either (1) Use of antibiotics or steroid, or (2) visiting ER or hospitalization	upto 20 years	No
Other	Annual rate of exacerbation (definition of exacerbation is described below)	Definition of exacerbation: Airway disease symptom aggravation requiring either (1) Use of antibiotics or steroid, or (2) visiting ER or hospitalization	upto 20 years	No
Primary	Death (time to death)	death from any cause, death from COPD-specific cause, death from CVD, malignancy	upto 20 years	No
Secondary	post-bronchodilator FEV1 change rates		upto 20 years (at least 3 years)	No