Duke University Hospital
Durham, North Carolina, 27705, United States
NCT Number: NCT04874610
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.
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Notify Me2 year–20 year
All sexes
Observational
Durham, North Carolina, 27705, United States
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administration of methylprednisolone Prescribed per Standard of care
Time frame: 0, 24, 48, 72, 96 hours after methylprednisolone dosing
Prednisolone levels at steady state concentration
Time frame: Up to 72 hours after methylprednisolone dosing
11-beta-hydroxysteroid dehydrogenase levels
Duke University
Other
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