The Nationwide Real-world Status of Oral Corticosteroid U... | NCT05750797

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

NCT05750797

Sponsor

Joon Young Choi

Status

Unknown status

Last Update Posted

Mar 6, 2023Actual

Enrollment

800,000Estimated

Phase

Not provided

Conditions

Asthma
Corticosteroid

Interventions

Oral corticosteroids

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2023Estimated

Primary Completion Date

Dec 2023Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

Feb 20, 2023

First Submission Date that Met QC Criteria

Feb 20, 2023

First Posted Date

Mar 2, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2023

Last Update Posted Date

Mar 6, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Joon Young Choi, Clinical assistant professor, Incheon St.Mary's HospitalSponsor-Investigator

Lead Sponsor

Joon Young ChoiOTHER

Collaborators

Name	Class
Seoul St. Mary's Hospital	OTHER
Hallym University Medical Center	OTHER
Konkuk University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

800,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oral corticosteroids	Drug	The prescription of OCS will be analyzed. OCS included betamethasone, deflazacort, dexamethasone, hydrocortisone, methylprednisolone, prednisolone, and triamcinolone.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
OCS prescription rates	Analysis the OCS prescription in all patients with asthma	1-year

Secondary Outcomes

Measure	Description	Time Frame
OCS prescription according to the asthma severity		1-year
OCS prescription according to age		1-year
OCS prescription according to sex

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Those who were diagnosed and treated as Asthma from 1-Jan-2019 to 31-Dec-2019

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Joon Young Choi, MD.PhD	Contact	82 10 5313 2937		tawoe@naver.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Incheon St. Mary's Hospital		Incheon	Gyeongki	21431	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

IPD cannot be publicaly available due to restriction.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000305	Adrenal Cortex Hormones

Ancestor Terms

ID	Term
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists

Browse Leaves

Not provided

Browse Branches

Not provided