NCT04874610

Steroid Metabolism in Obese and Non-Obese Pediatric Patients Hospitalized for Status Asthmaticus

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 15 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 2 Years – 20 Years
• Healthy volunteers: —

Summary

Single center, open-label, non-randomized study to assess the pharmacokinetic profile of methylprednisolone in healthy children 2-20 years of age admitted for asthma exacerbation.

Detailed description

This is a prospective study aiming to characterize the pharmacokinetics of methylprednisolone in obese and non-obese children hospitalized for asthma, and to build a metabolomic profile for each cohort. The primary hypothesis is that the obese cohort will have increased methylprednisolone clearance compared to the non-obese cohort. The secondary hypothesis is that the obese cohort will have decreased amounts of 11-β-hydroxysteroid dehydrogenase in the serum which will correlate to abnormalities in steroid clearance. The tertiary hypothesis is that the obese cohort will have increased levels of branched chain amino acids and inflammatory markers which will correlate to disease severity.

Conditions

• Pediatric Obesity
• Asthma in Children

Interventions

Type	Name	Description
DRUG	Methylprednisolone	Administration of methylprednisolone Prescribed per Standard of care

Timeline

• Start date: 2021-08-16
• Primary completion: 2022-03-31
• Completion: 2022-03-31
• First posted: 2021-05-05
• Last updated: 2022-07-01

Locations

1 site across 1 country: United States