Pediatric Asthma Trial of Corticosteroid Heterogeneity (PATCH): Trial of Dexamethasone Versus Methylprednisolone for Pediatric Critical Asthma
PATCH
1 other identifier
interventional
159
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2026
CompletedFirst Posted
Study publicly available on registry
March 6, 2026
CompletedStudy Start
First participant enrolled
May 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 14, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 14, 2028
March 6, 2026
March 1, 2026
2 years
March 3, 2026
March 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Post-Discharge Systemic Corticosteroid Exposure
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
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 Outcomes (2)
Pediatric Asthma Quality of Life
Measured at 30-days post hospital discharge
Critical Asthma Adjunct Intervention Free Hours
From Enrollment through 30 days post Hospital Discharge
Study Arms (3)
Dexamethasone Once Daily Dosing for 2days
ACTIVE COMPARATORDexamethasone Intravenous 0.6mg/kg/dose once daily for two days (Max Dose: 16mg)
Dexamethasone Every 6-Hours Dosing for 2 days
ACTIVE COMPARATORDexamethasone 0.25mg/kg/dose every 6-hours for 8-total doses (i.e., 2 days) Max Dose 16mg per administration
Methylprednisolone Every 6-hours Dosing for 5-days
ACTIVE COMPARATORMethylprednisolone 1mg/kg every 6-hours for 5-days
Interventions
For this intervention, Dexamethasone will be administered at 0.6mg/kg/dose once daily for a maximum dose of 16 mg for 2 days
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
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
Eligibility Criteria
You may qualify if:
- Age 3-17 years
- Intensive care unit admission
- Treatment for critical asthma
You may not qualify if:
- History of unrepaired critical congenital heart disease
- History of cystic fibrosis
- Active tracheostomy dependence
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701, United States
Related Publications (3)
Sellers AR, Roddy MR, Darville KK, Sanchez-Teppa B, McKinley SD, Sochet AA. Dexamethasone for Pediatric Critical Asthma: A Multicenter Descriptive Study. J Intensive Care Med. 2022 Nov;37(11):1520-1527. doi: 10.1177/08850666221082540. Epub 2022 Mar 3.
PMID: 35236174BACKGROUNDRoddy MR, Sellers AR, Darville KK, Teppa-Sanchez B, McKinley SD, Martin M, Goldenberg NA, Nakagawa TA, Sochet AA. Dexamethasone versus methylprednisolone for critical asthma: A single center, open-label, parallel-group clinical trial. Pediatr Pulmonol. 2023 Jun;58(6):1719-1727. doi: 10.1002/ppul.26386. Epub 2023 Mar 17.
PMID: 36929864BACKGROUNDFowler CA, Ryder JM, Roberts AR, Sochet AA, Roddy MR. Methylprednisolone dosing for pediatric critical asthma: a single-center cohort study. J Asthma. 2024 Dec;61(12):1672-1678. doi: 10.1080/02770903.2024.2375276. Epub 2024 Jul 6.
PMID: 38954523BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Meghan Sorondo, PharmD
Johns Hopkins All Children's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2026
First Posted
March 6, 2026
Study Start
May 15, 2026
Primary Completion (Estimated)
May 14, 2028
Study Completion (Estimated)
May 14, 2028
Last Updated
March 6, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share