AsthmaNCT05750797
The Nationwide Real-world Status of Oral Corticosteroid Use in Patients With Asthma
An observational study of Asthma and Corticosteroid, run by Joon Young Choi at 1 site in South Korea.
Trial summary
The Health Insurance Review and Assessment Service (HIRA) database contains nationwide claim data. By utilizing this database, the investigators aimed to analyze the current status of OCS use in South Korea by using HIRA database. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Asthma, Corticosteroid
- What is being tested?
- Oral corticosteroids
- Type of treatment
- Pill or oral medicine
- How many people
- 800,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2023to Dec 2023
- How long will I take part?
- 1 Year
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Those who were diagnosed and treated as Asthma from 1-Jan-2019 to 31-Dec-2019
Who may be able to join
- Age ≥ 15 years;
- ICD-10 codes for asthma (J45.x-J46) as the primary or within fourth secondary diagnosis
- use of more than one drug for asthma at least twice per year (long acting muscarinic antagonist (LAMA), long acting beta2 agonist (LABA), ICS, ICS+LABA, short acting muscarinic antagonist (SAMA), short acting beta2 agonist (SABA), SAMA+SABA, theophylline, leukotriene antagonist, systemic corticosteroids, or systemic beta agonist).
Who cannot join
- Those who are not in the insurance system
Trial locations and contacts
1 site in 1 country.
About this study
The Health Insurance Review and Assessment Service (HIRA) database contains nationwide claim data. By utilizing this database, the investigators aimed to analyze the current status of OCS use in South Korea by using HIRA database.
Read the detailed description
South Korea has a compulsory universal health insurance system for entire Korean population. The number of people who are covered was more than 50 million. The Health Insurance Review and Assessment Service (HIRA) database contains nationwide claim data. By utilizing this database, the investigators have performed many studies regarding asthma in South Korea. In this study, the investigators aimed to analyze the current status of OCS use in South Korea by using HIRA database.
Primary outcome was the OCS prescription in all patients with asthma. Secondary outcome was OCS prescription according to the asthma severity, age, sex, socioeconomic status and the type of hospital.
Inclusion criteria was 1) Age ≥ 15 years; 2) ICD-10 codes for asthma (J45.x-J46) as the primary or within fourth secondary diagnosis; 3) use of more than one drug for asthma at least twice per year (long acting muscarinic antagonist (LAMA), long acting beta2 agonist (LABA), ICS, ICS+LABA, short acting muscarinic antagonist (SAMA), short acting beta2 agonist (SABA), SAMA+SABA, theophylline, leukotriene antagonist, systemic corticosteroids, or systemic beta agonist).
- Conditions
- Asthma, Corticosteroid
- Being tested
- Oral corticosteroids
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral corticosteroidsDrug
The prescription of OCS will be analyzed. OCS included betamethasone, deflazacort, dexamethasone, hydrocortisone, methylprednisolone, prednisolone, and triamcinolone.
What is being measured
The primary outcome is the main question the study is designed to answer.
OCS prescription rates
Analysis the OCS prescription in all patients with asthma
Measured: 1-year
Secondary outcomes (5)
OCS prescription according to the asthma severity
Measured: 1-year
OCS prescription according to age
Measured: 1-year
OCS prescription according to sex
Measured: 1-year
OCS prescription according to socioeconomic status
Measured: 1-year
OCS prescription according to the type of hospital
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start1 Mar 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 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.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 800,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Joon Young Choi
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul St. Mary's Hospital, Hallym University Medical Center, Konkuk University Hospital
- Responsible party
- Sponsor-investigator, Joon Young Choi, Incheon St.Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750797
- Sponsor's protocol ID
- ESR-21-21329
- Status last verified
- Mar 2023
- First submitted
- 20 Feb 2023
- Last updated
- 6 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD cannot be publicaly available due to restriction.
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Nationwide Real-world Status of Oral Corticosteroid Use in Patients With Asthma
- ClinicalTrials.gov ID
- NCT05750797
- Acronym / sponsor ID
- ESR-21-21329
- Conditions
- Asthma, Corticosteroid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800,000 participants (estimated)
- Lead sponsor
- Joon Young ChoiUniversity, hospital or other
- Collaborators
- Seoul St. Mary's Hospital, Hallym University Medical Center, Konkuk University Hospital
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 2 Mar 2023 (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.
The Health Insurance Review and Assessment Service (HIRA) database contains nationwide claim data. By utilizing this database, the investigators aimed to analyze the current status of OCS use in South Korea by using HIRA database.
Detailed description
South Korea has a compulsory universal health insurance system for entire Korean population. The number of people who are covered was more than 50 million. The Health Insurance Review and Assessment Service (HIRA) database contains nationwide claim data. By utilizing this database, the investigators have performed many studies regarding asthma in South Korea. In this study, the investigators aimed to analyze the current status of OCS use in South Korea by using HIRA database.
Primary outcome was the OCS prescription in all patients with asthma. Secondary outcome was OCS prescription according to the asthma severity, age, sex, socioeconomic status and the type of hospital.
Inclusion criteria was 1) Age ≥ 15 years; 2) ICD-10 codes for asthma (J45.x-J46) as the primary or within fourth secondary diagnosis; 3) use of more than one drug for asthma at least twice per year (long acting muscarinic antagonist (LAMA), long acting beta2 agonist (LABA), ICS, ICS+LABA, short acting muscarinic antagonist (SAMA), short acting beta2 agonist (SABA), SAMA+SABA, theophylline, leukotriene antagonist, systemic corticosteroids, or systemic beta agonist).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Those who were diagnosed and treated as Asthma from 1-Jan-2019 to 31-Dec-2019
Key inclusion criteria (3 listed)
- Age ≥ 15 years;
- ICD-10 codes for asthma (J45.x-J46) as the primary or within fourth secondary diagnosis
- use of more than one drug for asthma at least twice per year (long acting muscarinic antagonist (LAMA), long acting beta2 agonist (LABA), ICS, ICS+LABA, short acting muscarinic antagonist (SAMA), short acting beta2 agonist (SABA), SAMA+SABA, theophylline, leukotriene antagonist, systemic corticosteroids, or systemic beta agonist).
Key exclusion criteria (1 listed)
- Those who are not in the insurance system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral corticosteroidsThe prescription of OCS will be analyzed. OCS included betamethasone, deflazacort, dexamethasone, hydrocortisone, methylprednisolone, prednisolone, and triamcinolone. | Drug | – |
Primary outcome
OCS prescription rates
Time frame: 1-year
Analysis the OCS prescription in all patients with asthma
5 secondary outcomes
OCS prescription according to the asthma severity
Time frame: 1-year
OCS prescription according to age
Time frame: 1-year
OCS prescription according to sex
Time frame: 1-year
OCS prescription according to socioeconomic status
Time frame: 1-year
OCS prescription according to the type of hospital
Time frame: 1-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Individual participant dataSharing planned: No. IPD cannot be publicaly available due to restriction.
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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.
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 and Corticosteroid, run by Joon Young Choi 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 3 inclusion and 1 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 6 Mar 2023. 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?
Contact Joon Young Choi, MD.PhD (82 10 5313 2937, tawoe@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OCS prescription rates (time frame: 1-year). 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 6 Mar 2023.