Oral corticosteroids in Asthma and Corticosteroid - Clinical Trials Registry

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Drug: Oral corticosteroids

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