Pediatric Asthma Trial of Corticosteroid Heterogeneity (PATCH): Trial of Dexamethasone Versus Methylprednisolone for Pediatric Critical Asthma (PATCH)

March 3, 2026 updated by: Johns Hopkins All Children's Hospital

Pediatric Asthma Trial of Corticosteroid Heterogeneity (PATCH): A Phase 2 Prospective Randomized Open Blinded End-point (PROBE) Design, Randomized Clinical Trial of Dexamethasone Versus Methylprednisolone for Pediatric Critical Asthma

Acute asthma exacerbation is caused by dysregulated pulmonary inflammatory pathways such that standard treatment includes prompt administration of exogenous systemic corticosteroids (SCs), but there remains an ongoing dialogue among the expert medical community regarding the superiority of specific SCs including dose, frequency of administration, route, and delivery. Regimens are often chosen based on provider preference, and different strategies include once-daily dosing (ODD) dexamethasone (DM) 0.6 mg/kg/dose for 2 days, every 6 hours (q6h) DM 0.25 mg/kg/dose for 2 days, and methylprednisolone (MP) 1 mg/kg/dose every 6 hours for 5-days.

To address this knowledge gap, the investigators plan to perform a single-center, phase 2, randomized clinical trial of children 3-17 years of age hospitalized for critical asthma (CA) randomized to one of three regimens above. The study would be powered to evaluate rates of additional prescriptions of SC and also secondarily evaluate quality of life metrics.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Acute asthma exacerbation is caused by dysregulated pulmonary inflammatory pathways such that standard treatment includes prompt administration of exogenous SCs.17 These agents placate the inflammatory process mediated by airway and systemic leukocytes and have been shown to improve the efficacy of nebulized bronchodilators (i.e., β-2 agonists).18-23 There remains an ongoing dialogue among the expert medical community regarding the superiority of specific SCs including dose, frequency of administration, route, and delivery. While the benefits of SCs for asthma exacerbation have been demonstrated in observational data and rare early phase trials, only one prospective trial conducted by the investigators group 6 has specifically compared IV SCs in the Pediatric Intensive Care Unit (PICU) setting among children hospitalized with CA.1 As a result, specific IV SCs for CA are chosen at the discretion of clinical providers with wide variety observed including ODD DM at 0.6mg/kg/dose for 2 days, q6h DM at 0.25 mg/kg/dose for 2 days, and MP 1mg/kg/dose every 6 hours for 5-days24.

In the investigators early phase clinical trial for SCs for pediatric CA, the investigators compared q6H DM to MP and detected no difference in SC-related adverse events of special interest (AESI), continuous β-2-agonist exposure, and hospital LOS.6 Routine endpoints (i.e., mortality, invasive mechanical ventilation (IMV), and LOS) exhibit limited variability and are rare in cases of pediatric CA. As such, more pragmatic clinical endpoints have been proposed by the investigators research group and others including same cause rehospitalization rates, additional post-discharge SC exposure rate, and markers of QOL including the number of missed school days / sports, and a validated QOL scale (i.e., mini-Pediatric Asthma Quality of Life Questionnaire (PAQLQ12-16). For children discharged from Johns Hopkins All Children's with CA, the investigators estimate rehospitalization rates for CA with receipt of subsequent SCs ≤ 30 days of discharge are between 18-45%, with lower rates observed for MP over DM.

To rigorously address these knowledge gaps, the investigators plan to perform a single-center, phase 2, randomized clinical trial of children 3-17 years of age hospitalized for CA randomized to IV DM (stratified further by q6h and ODD dosing regimens) or IV MP powered to evaluate pragmatic post-discharge endpoints including the rate of additional SC exposure ≤ 30-days of hospital discharge and QOL measures at 30-days after hospital discharge measured by the mini-PAQLQ, the number of missed school days, and number of missed days of play and sports. The investigators will additionally characterize and compare safety (i.e., SC-related AESI and serious adverse events (SAEs) and acute inpatient clinical efficacy (i.e., CA-adjunct intervention free hours) endpoints by randomized SC arms.

Study Type

Interventional

Enrollment (Estimated)

159

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Meghan Sorondo, PharmD
  • Phone Number: 727-767-7044
  • Email: mroddy4@jhmi.edu

Study Locations

  • United States
    • Florida
      • St. Petersburg, Florida, United States, 33701
        • Johns Hopkins All Children's Hospital
        • Contact:
        • Contact:
          • Anthony Sochet, MD, MSc
          • Phone Number: 7277672912
          • Email: sochet@jh.edu
        • Principal Investigator:
          • Meghan Sorondo, PharmD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 3-17 years
  • Intensive care unit admission
  • Treatment for critical asthma

Exclusion Criteria:

  • History of unrepaired critical congenital heart disease
  • History of cystic fibrosis
  • Active tracheostomy dependence

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dexamethasone Once Daily Dosing for 2days
Dexamethasone Intravenous 0.6mg/kg/dose once daily for two days (Max Dose: 16mg)
Drug: Dexamethasone (0.6mg/kg; Max 16mg) Once Daily
For this intervention, Dexamethasone will be administered at 0.6mg/kg/dose once daily for a maximum dose of 16 mg for 2 days
Active Comparator: Dexamethasone Every 6-Hours Dosing for 2 days
Dexamethasone 0.25mg/kg/dose every 6-hours for 8-total doses (i.e., 2 days) Max Dose 16mg per administration
Drug: Dexamethasone (0.25 mg/kg/dose, Max dose 16mg) every 6-hours
For this intervention, Dexamethasone will be administered at 0.25mg/kg/dose every 6 hours for a maximum dose of 16 mg for 2 days
Active Comparator: Methylprednisolone Every 6-hours Dosing for 5-days
Methylprednisolone 1mg/kg every 6-hours for 5-days
Drug: Methylprednisolone
For this intervention, Methylprednisolone will be administered at 1 mg/kg/dose every 6 hours for a maximum dose of 60 mg for 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-Discharge Systemic Corticosteroid Exposure
Time Frame: Within 30 days of hospital discharge
Aggregate occurrence rate (i.e., risk) of systemic corticosteroid exposures after hospital discharge
Within 30 days of hospital discharge
Cumulative Adverse Events of Special Interest
Time Frame: From enrollment through 30-days following hospital discharge
Cumulative Adverse Events of Special Interest are inclusive of symptomatic hypertension requiring an antihypertensive agent, symptomatic hyperglycemia requiring insulin, symptomatic agitation requiring antipsychotic agent or sedative administration, adrenal insufficiency, and candidiasis.
From enrollment through 30-days following hospital discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pediatric Asthma Quality of Life
Time Frame: Measured at 30-days post hospital discharge
Pediatric Asthma Quality of Life Questionnaire. Mean scores range from 1 to 7. Higher score indicating higher quality of life.
Measured at 30-days post hospital discharge
Critical Asthma Adjunct Intervention Free Hours
Time Frame: From Enrollment through 30 days post Hospital Discharge
Critical Asthma Adjunct Intervention Free Hours includes the cumulative number of hours during hospitalization where no critical asthma adjunct interventions are administered.
From Enrollment through 30 days post Hospital Discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins All Children's Hospital

Investigators

  • Principal Investigator: Meghan Sorondo, PharmD, Johns Hopkins All Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 15, 2026

Primary Completion (Estimated)

May 14, 2028

Study Completion (Estimated)

May 14, 2028

Study Registration Dates

First Submitted

March 3, 2026

First Submitted That Met QC Criteria

March 3, 2026

First Posted (Actual)

March 6, 2026

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00544439

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

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Asthma (Diagnosis)

Clinical Trials on Dexamethasone (0.6mg/kg; Max 16mg) Once Daily

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe