The Nationwide Real-world Status of Oral Corticosteroid Use in Patients With Asthma

March 3, 2023 updated by: Joon Young Choi
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

800000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Joon Young Choi, MD.PhD
  • Phone Number: 82 10 5313 2937
  • Email: tawoe@naver.com

Study Locations

  • Korea, Republic of
    • Gyeongki
      • Incheon, Gyeongki, Korea, Republic of, 21431
        • Incheon St. Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Those who were diagnosed and treated as Asthma from 1-Jan-2019 to 31-Dec-2019

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

• Those who are not in the insurance system

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OCS prescription rates
Time Frame: 1-year
Analysis the OCS prescription in all patients with asthma
1-year

Secondary Outcome Measures

Outcome Measure
Time Frame
OCS prescription according to the asthma severity
Time Frame: 1-year
1-year
OCS prescription according to age
Time Frame: 1-year
1-year
OCS prescription according to sex
Time Frame: 1-year
1-year
OCS prescription according to socioeconomic status
Time Frame: 1-year
1-year
OCS prescription according to the type of hospital
Time Frame: 1-year
1-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joon Young Choi

Collaborators

Seoul St. Mary's Hospital
Hallym University Medical Center
Konkuk University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2023

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

February 20, 2023

First Submitted That Met QC Criteria

February 20, 2023

First Posted (Actual)

March 2, 2023

Study Record Updates

Last Update Posted (Estimate)

March 6, 2023

Last Update Submitted That Met QC Criteria

March 3, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESR-21-21329

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD cannot be publicaly available due to restriction.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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