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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05750797
Other study ID # ESR-21-21329
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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