Effects of long-term steroid use on metabolic diseases in asthma patients
Long-term Comparative Effectiveness for Osteoporosis/Osteoporosis and Metabolic Disease in Adult Asthmatic Patients Maintaining Inhaled/Systemic Corticosteroid: a Real-world Evidence
This study is trying to see how long-term use of different doses of asthma steroids affects the risk of conditions like osteoporosis, diabetes, and high blood pressure in adults with asthma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ajou University School of Medicine Academic / other |
| Locations | 1 site (Suwon, Gyeonggi) |
| Trial ID | NCT06279078 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare clinical outcomes between asthma patients receiving high and low cumulative doses of corticosteroids over the long term. It investigates the relationship between high corticosteroid doses and the prevalence of osteoporosis, diabetes, hypertension, and hyperlipidemia in adult asthmatics. The study focuses on adults over 18 years who have been on inhaled corticosteroids for more than 12 months, assessing how these medications impact bone health and metabolic conditions. The research will analyze data from patients at Ajou University Medical Center in South Korea.
Who should consider this trial
Good fit: Ideal candidates are adult asthmatics over 18 years who have been on inhaled corticosteroids for over 12 months.
Not a fit: Patients younger than 18 years or males under 50 years with low osteoporosis risk may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the long-term risks associated with corticosteroid use in asthma patients, potentially guiding safer treatment strategies.
How similar studies have performed: Other studies have indicated potential risks associated with high-dose corticosteroid use, suggesting this approach is relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Suwon, Gyeonggi
- Ajou University Medical Center — Suwon, Gyeonggi, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Hyun-Seob Jeon, M.D.
- Email: googlingpenguin@gmail.com
- Phone: +82-31-219-4612
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.