Long-term Effect of Steroid on Metabolic Diseases in Asthmatics

NCT ID: NCT06279078

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

19968 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-30

Study Completion Date

2025-06-30

Brief Summary

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The goal of this retrospective/observational study is to compare the clinical outcomes between the high-cumulative-dose group and the low- cumulative-dose group of oral/inhaled corticosteroid in the long-term management of asthma patients. The main hypothesis are:

i. High cumulative dose of corticosteroid is related to the prevalence of osteoporosis/osteoporosis in the long-term management of adult asthma.

ii. High cumulative dose of corticosteroid can affect populations that have a high-risk of osteoporosis (females over 50 years of age).

iii. High cumulative dose of corticosteroid is related to the prevalence of diabetes mellitus, hypertension, and hyperlipidemia in the long-term management of adult asthma.

iv. High cumulative dose of corticosteroid affects bone metabolism-related diagnostic tests and laboratory values and the prescription rate of bone metabolism-related medications.

Detailed Description

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Conditions

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Asthma Osteoporosis, Osteopenia Osteoporosis Risk Osteoporotic Fractures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Corticosteroid

oral/inhaled corticosteroid

Intervention Type DRUG

Other Intervention Names

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inhaled corticosteroid

Eligibility Criteria

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Inclusion Criteria

ii. At least 1 asthma diagnosis within 1 year before the first corticosteroid exposure date by asthma specialists at Ajou University Medical Center (AUMC, Suwon, South Korea) with informed consent.

iii. A high cumulative dose is defined as the dose of corticosteroids above the mean cumulative dose of corticosteroids prescribed during 1 year.

iv. The equivalent dose will use for calculating the mean cumulative dose of each inhaled corticosteroid inhaler or systemic corticosteroid prescribed.

v. Prescriptions within 365 days from the first prescription will be assumed to be continuous, and the cohort end date will be defined as the end of the continuous drug exposure.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

Ajou University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Hyun-Seob Jeon

Clinical fellow, dept. of Allergy and Clinical Immunology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ajou University Medical Center

Suwon, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AJOUIRB-DB-2023-446

Identifier Type: -

Identifier Source: org_study_id

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