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

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.

Study Overview

• Status: Completed
• Conditions: Pediatric Obesity; Asthma in Children
• Intervention / Treatment: Drug: Methylprednisolone

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.

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

1. Age between 2 years and 20 years inclusive
2. Written informed consent provided by a parent or legal guardian
3. Admitted to Duke Children's Hospital for primary reason of asthma exacerbation (and treated with methylprednisolone)
4. BMI-percentile greater than 95th for obese subjects and BMI less than 95th percentile for non-obese subjects

Exclusion Criteria:

1. Patients with suspected liver failure, renal failure, sepsis, or cardiopulmonary instability deemed by the PI.
2. Receiving any extracorporeal life support including extracorporeal membrane oxygenation, ventricular assist devices, and renal replacement therapy at enrollment
3. Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the data.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Caitlin King, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2021
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: May 3, 2021
• First Submitted That Met QC Criteria: May 3, 2021
• First Posted (Actual): May 5, 2021

Study Record Updates

• Last Update Posted (Actual): July 1, 2022
• Last Update Submitted That Met QC Criteria: June 30, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Respiratory Hypersensitivity; Hypersensitivity; Obesity; Asthma; Pediatric Obesity; Status Asthmaticus; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• Other Study ID Numbers: Pro00108152

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No