AsthmaNCT03509259
Cardiovascular Diseases in Elderly Asthma
An observational study of Asthma, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study is a cross-sectional study to evaluate the relationship between coronary calcium score and clinical parameters of asthma such as onset of disease, lung function parameter and airway inflammation parameter (sputum eosinophil or FeNO) in Korean elderly asthma (regardless of whether they have concomittent COPD… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma
- How many people
- 72 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Mar 2019to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects who visited Allergy Clinic in SMG-SNU Boramae Medical Center for asthma or ACO
Who may be able to join
- If the doctor has been diagnosed with asthma and one or more of the following criteria is met;
- FEV1 increased more than 12% \& 200 mL after 10-20 minutes of inhalation of short-acting bronchodilator (200-400 mg salbutamol)
- Positive bronchial provocation tests (methacholine, mannitol, exercise, aspirin, etc.)
- FEV1 Increased more than 12% \& 200 mL from baseline FEV1 after anti-inflammatory treatment for 4 weeks or longer.
Who cannot join
- Those who were already diagnosed and treated for coronary artery diseases.
- Those with other structural lung diseases such as Tuberculosis destroyed lung and interstitial lung diseases
- Those who are unable to conduct a test or questionnaire due to severe systemic illness, or cognitive dysfunction.
- Those who are participating in other clinical trial using IND(investigational new drug) or finished other clinical trial within 30 days.
- Those who refuse to participate in the study or withdraw the consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Discovering Risk Factors for Cardiovascular Diseases in Elderly Asthma
This study is a cross-sectional study to evaluate the relationship between coronary calcium score and clinical parameters of asthma such as onset of disease, lung function parameter and airway inflammation parameter (sputum eosinophil or FeNO) in Korean elderly asthma (regardless of whether they have concomittent COPD or not) patients
Read the detailed description
Subjects who visited Allergy Clinic in SMG-SNU Boramae Medical Center for asthma or ACO will be recruited consecutively. Subjects who meets the inclusion criteria and agree to participate in the study will take coronary artery calcium scoring CT and asthma CT (inspiration and expiration images). The correlation between the degree of coronary calcification and airway diameter, airway wall thickness, air-trapping and emphysema will be evaluated as well as clinical parameters of asthma. We will also compare those correlations from the images of healthy control subjects who performed the coronary calcium scoring CT for health checkup purpose.
- Conditions
- Asthma
- Medical subject headings
- Asthma
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 |
|---|---|---|
| Asthma | If the doctor has been diagnosed with asthma and one or more of the following criteria is met; 1. FEV1 (Forced expiratory volume in 1 second) increased more than 12% \& 200 mL after 10-20 minutes of inhalation of short-acting bronchodilator (200-400 mg salbutamol) 2. Positive bronchial provocation tests (methacholine, mannitol, exercise, aspirin, etc.) 3. FEV1 Increased more than 12% \& 200 mL from baseline FEV1 after anti-inflammatory treatment for 4 weeks or longer. They can have concomittent COPD or not | |
| Healthy control | Subjects who performed coronary artery calcium scoring CT for health checkup purpose.(retrospective group = historical control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
coronary calcium score
coronary calcium score from coronary calcium scoring CT which, we assumed to be a surrogate marker for cardiovascular risk.
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start21 Mar 2019
- Primary completion12 Mar 2021
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Responsible party
- Sponsor
- Investigators
- Min-Suk Yang, MD, Principal investigator, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03509259
- Sponsor's protocol ID
- L-2017-313
- Status last verified
- Mar 2021
- First submitted
- 29 Mar 2018
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discovering Risk Factors for Cardiovascular Diseases in Elderly Asthma
- ClinicalTrials.gov ID
- NCT03509259
- Acronym / sponsor ID
- L-2017-313
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Study start
- 21 Mar 2019 (actual)
- Primary completion
- 12 Mar 2021 (actual)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 26 Apr 2018 (actual)
- 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 study is a cross-sectional study to evaluate the relationship between coronary calcium score and clinical parameters of asthma such as onset of disease, lung function parameter and airway inflammation parameter (sputum eosinophil or FeNO) in Korean elderly asthma (regardless of whether they have concomittent COPD or not) patients
Detailed description
Subjects who visited Allergy Clinic in SMG-SNU Boramae Medical Center for asthma or ACO will be recruited consecutively. Subjects who meets the inclusion criteria and agree to participate in the study will take coronary artery calcium scoring CT and asthma CT (inspiration and expiration images). The correlation between the degree of coronary calcification and airway diameter, airway wall thickness, air-trapping and emphysema will be evaluated as well as clinical parameters of asthma. We will also compare those correlations from the images of healthy control subjects who performed the coronary calcium scoring CT for health checkup purpose.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthma | – | –If the doctor has been diagnosed with asthma and one or more of the following criteria is met; 1. FEV1 (Forced expiratory volume in 1 second) increased more than 12% \& 200 mL after 10-20 minutes of inhalation of short-acting bronchodilator (200-400 mg salbutamol) 2. Positive bronchial provocation tests (methacholine, mannitol, exercise, aspirin, etc.) 3. FEV1 Increased more than 12% \& 200 mL from baseline FEV1 after anti-inflammatory treatment for 4 weeks or longer. They can have concomittent COPD or not |
| Healthy control | – | –Subjects who performed coronary artery calcium scoring CT for health checkup purpose.(retrospective group = historical control group) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who visited Allergy Clinic in SMG-SNU Boramae Medical Center for asthma or ACO
Key inclusion criteria (4 listed)
- If the doctor has been diagnosed with asthma and one or more of the following criteria is met;
Key exclusion criteria (5 listed)
- Those who were already diagnosed and treated for coronary artery diseases.
- Those with other structural lung diseases such as Tuberculosis destroyed lung and interstitial lung diseases
- Those who are unable to conduct a test or questionnaire due to severe systemic illness, or cognitive dysfunction.
- Those who are participating in other clinical trial using IND(investigational new drug) or finished other clinical trial within 30 days.
- Those who refuse to participate in the study or withdraw the consent.
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
coronary calcium score
Time frame: through study completion, an average of 1 month
coronary calcium score from coronary calcium scoring CT which, we assumed to be a surrogate marker for cardiovascular risk.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Min-Suk Yang, MD principal investigator
SMG-SNU Boramae Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Seoul National University Hospital at 1 site 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 4 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: status not confirmed, as of the sponsor's last update on 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
coronary calcium score (time frame: through study completion, an average of 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2021.