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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02527486
Other study ID # AW_registry
Secondary ID
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


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
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