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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-16

Study Completion Date

2022-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of Mometasone Furoate Metered Dose Inhaler in Children With Persistent Asthma (P04223)

NCT01502371

Asthma

COMPLETED PHASE2

Oral Prednisolone Dosing in Children Hospitalized With Asthma

NCT00257933

Asthma

COMPLETED PHASE4

Mechanisms for Dyspnea on Exertion in Children With Obesity and Asthma: Distinct Physiological Phenotypes

NCT04184609

Asthma in Children Dyspnea; Asthmatic Obesity, Childhood

WITHDRAWN PHASE4

Steroids in Children Hospitalized With Asthma

NCT02780479

Asthma Status Asthmaticus Wheezes

TERMINATED PHASE4

Steroids In The Management Of Acute Asthma Exacerbations In Children, Which Form Is More Suitable?

NCT03204760

Steroids In Management Of Acute Asthma Exacerbations

UNKNOWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Pediatric Obesity Asthma in Children

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BMI > 95

Cohort 1: greater than or equal to 95%ile body mass index

Methylprednisolone

Intervention Type DRUG

Administration of methylprednisolone Prescribed per Standard of care

BMI < 95

Cohort 2: less than 95%ile body mass index

Methylprednisolone

Intervention Type DRUG

Administration of methylprednisolone Prescribed per Standard of care

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Methylprednisolone

Administration of methylprednisolone Prescribed per Standard of care

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No