Clinical trial NCT05750797: The Nationwide Real-world Status of Oral Corticosteroid Use in Patients With Asthma
Official title: The Nationwide Real-world Status of Oral Corticosteroid Use in Patients With Asthma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma
Corticosteroid
Lead sponsor: Incheon St.Mary's Hospital
Sponsor class: OTHER
Collaborators: name: Seoul St. Mary's Hospital
name: Hallym University Medical Center
name: Konkuk University Hospital
First posted: 2023-03-02
Enrollment: 800000
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those who were diagnosed and treated as Asthma from 1-Jan-2019 to 31-Dec-2019

Brief 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: OCS prescription rates
timeFrame: 1-year
Secondary outcomes:
measure: OCS prescription according to the asthma severity
timeFrame: 1-year
measure: OCS prescription according to age
timeFrame: 1-year
measure: OCS prescription according to sex
timeFrame: 1-year
measure: OCS prescription according to socioeconomic status
timeFrame: 1-year
measure: OCS prescription according to the type of hospital
timeFrame: 1-year
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Incheon St. Mary's Hospital
state: Gyeongki
Study officials:
References: