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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Republic of Korea
Ajou University Medical Center
RECRUITING
Suwon
Contact Information
Primary
Hyun-Seob Jeon, M.D.
googlingpenguin@gmail.com
+82-31-219-4612
Backup
Hae-Sim Park, M.D., Ph.D.
hspark@ajou.ac.kr
+82-31-219-4779
Time Frame
Start Date: 2023-12-30
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 20000
Sponsors
Leads: Ajou University School of Medicine
Collaborators: AstraZeneca

This content was sourced from clinicaltrials.gov