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

Sponsor
Joon Young Choi (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05750797
Collaborator
Seoul St. Mary's Hospital (Other), Hallym University Medical Center (Other), Konkuk University Hospital (Other)
800,000
Enrollment
1
Location
9
Anticipated Duration (Months)
88545.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
800000 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
The Nationwide Real-world Status of Oral Corticosteroid Use in Patients With Asthma
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Outcome Measures

Primary Outcome Measures

  1. OCS prescription rates [1-year]

    Analysis the OCS prescription in all patients with asthma

Secondary Outcome Measures

  1. OCS prescription according to the asthma severity [1-year]

  2. OCS prescription according to age [1-year]

  3. OCS prescription according to sex [1-year]

  4. OCS prescription according to socioeconomic status [1-year]

  5. OCS prescription according to the type of hospital [1-year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Incheon St. Mary's Hospital Incheon Gyeongki Korea, Republic of 21431

Sponsors and Collaborators

  • Joon Young Choi
  • Seoul St. Mary's Hospital
  • Hallym University Medical Center
  • Konkuk University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Joon Young Choi, Clinical assistant professor, Incheon St.Mary's Hospital
ClinicalTrials.gov Identifier:
NCT05750797
Other Study ID Numbers:
  • ESR-21-21329
First Posted:
Mar 2, 2023
Last Update Posted:
Mar 6, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Asthma

Study Results

No Results Posted as of Mar 6, 2023