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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05750797
• Other study ID #: ESR-21-21329
• Status: Not yet recruiting
• Start date: March 1, 2023
• Est. completion date: December 2023

Study information

• Verified date: March 2023
• Source: Incheon St.Mary's Hospital
• Contact: Joon Young Choi, MD.PhD
• Phone: 82 10 5313 2937
• Email: tawoe[@]naver.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 800000
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Corticosteroid

Intervention

Drug:
• Oral corticosteroids
The prescription of OCS will be analyzed. OCS included betamethasone, deflazacort, dexamethasone, hydrocortisone, methylprednisolone, prednisolone, and triamcinolone.

Locations

Country	Name	City	State
Korea, Republic of	Incheon St. Mary's Hospital	Incheon	Gyeongki

Sponsors (4)

Lead Sponsor	Collaborator
Joon Young Choi	Hallym University Medical Center, Konkuk University Hospital, Seoul St. Mary's Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OCS prescription rates	Analysis the OCS prescription in all patients with asthma	1-year
Secondary	OCS prescription according to the asthma severity		1-year
Secondary	OCS prescription according to age		1-year
Secondary	OCS prescription according to sex		1-year
Secondary	OCS prescription according to socioeconomic status		1-year
Secondary	OCS prescription according to the type of hospital		1-year