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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMI > 95 | Cohort 1: greater than or equal to 95%ile body mass index |
| |
| BMI < 95 | Cohort 2: less than 95%ile body mass index |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone | Drug | Administration of methylprednisolone Prescribed per Standard of care |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 11-beta-hydroxysteroid dehydrogenase as measured by ELISA | 11-beta-hydroxysteroid dehydrogenase levels | Up to 72 hours after methylprednisolone dosing |
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Inclusion Criteria:
Exclusion Criteria:
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Children and young adults 2-20 years of age who are admitted to Duke Hospital for primary reason of asthma exacerbation and are treated with methylprednisolone.
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| Name | Affiliation | Role |
|---|---|---|
| Caitlin King, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Hospital | Durham | North Carolina | 27705 | United States |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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Plasma from blood
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |