Long-term Effect of Steroid on Metabolic Diseases in Asthmatics

Asthma Clinical Trial

Official title:

Long-term Comparative Effectiveness for Osteoporosis/Osteoporosis and Metabolic Disease in Adult Asthmatic Patients Maintaining Inhaled/Systemic Corticosteroid: a Real-world Evidence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06279078
• Other study ID #: AJOUIRB-DB-2023-446
• Status: Recruiting
• Start date: December 30, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: February 2024
• Source: Ajou University School of Medicine
• Contact: Hyun-Seob Jeon, M.D.
• Phone: +82-31-219-4612
• Email: googlingpenguin[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: June 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

A. Inclusion criteria i. Adult asthmatics (over 18 years) who have maintained inhaled corticosteroid with or without systemic corticosteroid for more than 12 months before the index date in our Medical Center.

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.

B. Exclusion criteria i. Patients younger than 18 years ii. Patients younger than 50 years and males in high-risk population cohorts iii. Patients with osteoporosis or osteoporosis-related major fracture outcomes (pathological fracture due to osteoporosis, closed fracture of the femur, pelvis, and vertebral column) before the index date iv. Patients with corticosteroid-related outcomes (diabetes mellitus, hypertension, hyperlipidemia) before the index date (for secondary endpoint).

Related Conditions & MeSH terms

• Asthma
• Bone Diseases, Metabolic
• Metabolic Diseases
• Osteoporosis
• Osteoporosis Risk
• Osteoporosis, Osteopenia
• Osteoporotic Fractures

Intervention

Drug:
• Corticosteroid
oral/inhaled corticosteroid

Locations

Country	Name	City	State
Korea, Republic of	Ajou University Medical Center	Suwon	Gyeonggi

Sponsors (2)

Lead Sponsor	Collaborator
Ajou University School of Medicine	AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of osteoporosis/osteopenia	Prevalence of osteoporosis/osteopenia according to cumulative dose of steroid will be compared with incidence, incidence rate, and hazard ratio	5 years
Secondary	Bone mineral density (BMD) score	Change of BMD score (T-score), especially for L1-L4 and femur neck. (Z-score will also be evaluated for premenopausal women and men under 50 years of age)	5 years
Secondary	Total alkaline phosphatase	Change of bone metabolism-related tests	5 years
Secondary	Corrected calcium	Change of bone metabolism-related tests	5 years
Secondary	Serum phosphate	Change of bone metabolism-related tests	5 years
Secondary	Serum albumin	Change of bone metabolism-related tests (known to be reduced in osteoporosis patients)	5 years
Secondary	prevalence of steroid related comorbidities(Diabetes Mellitus, Hypertension, Hyperlipidemia, etc.)	Compare the prevalence of steroid related comorbidities(Diabetes Mellitus, Hypertension, Hyperlipidemia, etc.) according to cumulative dose of steroid with incidence, incidence rate, and hazard ratio	5 years