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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pediatric Obesity, Asthma in Children

Intervention / Treatment
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* Drug: Methylprednisolone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 2 years and 20 years inclusive Written informed consent provided by a parent or legal guardian Admitted to Duke Children's Hospital for primary reason of asthma exacerbation (and treated with methylprednisolone) BMI-percentile greater than 95th for obese subjects and BMI less than 95th percentile for non-obese subjects Exclusion Criteria: Patients with suspected liver failure, renal failure, sepsis, or cardiopulmonary instability deemed by the PI. Receiving any extracorporeal life support including extracorporeal membrane oxygenation, ventricular assist devices, and renal replacement therapy at enrollment Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the data.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BMI > 95<br>Cohort 1: greater than or equal to 95%ile body mass index | Drug: Methylprednisolone<br>* Administration of methylprednisolone Prescribed per Standard of care<br>|
| BMI < 95<br>Cohort 2: less than 95%ile body mass index | Drug: Methylprednisolone<br>* Administration of methylprednisolone Prescribed per Standard of care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Prednisolone concentration levels as measured by ELISA | Prednisolone levels at steady state concentration | 0, 24, 48, 72, 96 hours after methylprednisolone dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 11-beta-hydroxysteroid dehydrogenase as measured by ELISA | 11-beta-hydroxysteroid dehydrogenase levels | Up to 72 hours after methylprednisolone dosing |