Chronic Obstructive Pulmonary Disease (COPD)NCT02527486
Seoul National University Airway Registry
An observational study of Chronic Obstructive Pulmonary Disease (COPD) and Asthma, run by Seoul National University Hospital at 3 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), Asthma, Asthma With Chronic Obstructive Pulmonary Disease
- How many people
- 800 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Sep 2011to Dec 2031
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD Asthma ACOS Bronchiectasis TB-destroyed lung Other chronic airway diseases
Who may be able to join
- Postbronchodilator FEV1/FVC < 0.7 AND chronic respiratory symptom
- 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)
- COPD AND Asthma (regardless of smoking status)
Who cannot join
- -
- Asthma
- -
- ACOS
- -
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea3 sites, 2 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Ho-Il Yoon, M.D., dextro70@gmail.com
Ho-Il Yoon, M.D.
- Recruiting
Seoul National University Hospital
Seoul, 110-744
Chang-Hoon Lee, M.D.
- Active, not recruiting
Seoul Metropolitan Government-Seoul National University Boramae Medical Center
Seoul, 156-707
About this study
Official title: 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.
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD), Asthma, Asthma With Chronic Obstructive Pulmonary Disease, Bronchiectasis, Inactive Tuberculosis of Lung, Chronic Obstructive Airway Disease
- Keywords
- COPD, Asthma, ACOS, Bronchiectasis
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma, Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No predefined subgroups | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death (time to death)
death from any cause, death from COPD-specific cause, death from CVD, malignancy
Measured: upto 20 years
Secondary outcomes (1)
post-bronchodilator FEV1 change rates
Measured: upto 20 years (at least 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startSep 2011
- Primary completionDec 2021 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang-Hoon Lee, Seoul National University Hospital
- Investigators
- Chul-Gyu Yoo, M.D., Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02527486
- Sponsor's protocol ID
- AW_registry
- Status last verified
- Aug 2015
- First submitted
- 19 Dec 2014
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29482616Jo 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.
PubMed 28583262
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Registry for Chronic Airway Diseases
- ClinicalTrials.gov ID
- NCT02527486
- Acronym / sponsor ID
- AW_registry
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD), Asthma, Asthma With Chronic Obstructive Pulmonary Disease, Bronchiectasis, Inactive Tuberculosis of Lung, Chronic Obstructive Airway Disease
- Keywords
- COPD, Asthma, ACOS, Bronchiectasis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 19 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No predefined subgroups | – | – |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD Asthma ACOS Bronchiectasis TB-destroyed lung Other chronic airway diseases
Key inclusion criteria (3 listed)
- Postbronchodilator FEV1/FVC < 0.7 AND chronic respiratory symptom
- 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)
- COPD AND Asthma (regardless of smoking status)
Key exclusion criteria (5 listed)
- -
- Asthma
- -
- ACOS
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Death (time to death)
Time frame: upto 20 years
death from any cause, death from COPD-specific cause, death from CVD, malignancy
1 secondary outcome
post-bronchodilator FEV1 change rates
Time frame: upto 20 years (at least 3 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
- Derived from this study: PubMed 29482616Jo 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.
- Derived from this study: PubMed 28583262Jo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chul-Gyu Yoo, M.D. study chair
Seoul National University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease (COPD) and Asthma, run by Seoul National University Hospital at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chang-Hoon Lee, M.D. (82-2-2072-4743, kauri670@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time to death) (time frame: upto 20 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02527486, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2015.