Long-term Effect of Steroid on Metabolic Diseases in Asthmatics

Launched by AJOU UNIVERSITY SCHOOL OF MEDICINE · Feb 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the long-term effects of steroid medications on people with asthma, specifically looking at how different doses of these steroids might impact their bone health and risk of other health issues like diabetes and high blood pressure. Researchers want to find out if higher doses of steroids are linked to more cases of osteoporosis (a condition that weakens bones) and whether this is especially true for women over 50. They will also examine how these medications affect bone-related tests and the use of treatments for bone health.

To participate in this study, you need to be an adult over 18 years old who has been using inhaled corticosteroids for at least a year. However, certain people won't be eligible, such as those under 18, men under 50 who are at high risk, or anyone who has had major fractures due to osteoporosis before joining the study. Participants can expect to contribute to important research that could help improve asthma treatment and understand its side effects better. If you're interested, the study is currently recruiting participants at Ajou University Medical Center in South Korea.

Gender

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Eligibility criteria

• • 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).