NCT02527486

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
68mo left

Started Sep 2011

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

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 Progress73%
Sep 2011Dec 2031

Study Start

First participant enrolled

September 1, 2011

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2014

Completed
8 months until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2031

Expected
Last Updated

August 19, 2015

Status Verified

August 1, 2015

Enrollment Period

10.3 years

First QC Date

December 19, 2014

Last Update Submit

August 17, 2015

Conditions

Keywords

COPDAsthmaACOSBronchiectasis

Outcome Measures

Primary Outcomes (1)

  • Death (time to death)

    death from any cause, death from COPD-specific cause, death from CVD, malignancy

    upto 20 years

Secondary Outcomes (1)

  • post-bronchodilator FEV1 change rates

    upto 20 years (at least 3 years)

Other Outcomes (2)

  • Time to 1st exacerbation (definition of exacerbation is described below)

    upto 20 years

  • Annual rate of exacerbation (definition of exacerbation is described below)

    upto 20 years

Study Arms (1)

No predefined subgroups

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Postbronchodilator FEV1/FVC \< 0.7 AND chronic respiratory symptom

You may not qualify if:

  • Asthma
  • 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)
  • ACOS
  • COPD AND Asthma (regardless of smoking status)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

RECRUITING

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

Seoul Metropolitan Government-Seoul National University Boramae Medical Center

Seoul, 156-707, South Korea

ACTIVE NOT RECRUITING

Related Publications (2)

  • Jo YS, Park S, Kim DK, Yoo CG, Lee CH. The cutoff point of clinical chronic obstructive pulmonary disease questionnaire for more symptomatic patients. BMC Pulm Med. 2018 Feb 27;18(1):38. doi: 10.1186/s12890-018-0601-0.

  • Jo YS, Lee J, Yoon HI, Kim DK, Yoo CG, Lee CH. Different prevalence and clinical characteristics of asthma-chronic obstructive pulmonary disease overlap syndrome according to accepted criteria. Ann Allergy Asthma Immunol. 2017 Jun;118(6):696-703.e1. doi: 10.1016/j.anai.2017.04.010.

Biospecimen

Retention: SAMPLES WITH DNA

Blood (whole blood, serum, plasma, buffy coat) Urine

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveAsthmaBronchiectasis

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchial DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Chul-Gyu Yoo, M.D.

    Seoul National University Hospital

    STUDY CHAIR

Central Study Contacts

Chang-Hoon Lee, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

December 19, 2014

First Posted

August 19, 2015

Study Start

September 1, 2011

Primary Completion

December 1, 2021

Study Completion (Estimated)

December 1, 2031

Last Updated

August 19, 2015

Record last verified: 2015-08

Locations