Pediatric Asthma Trial of Corticosteroid Heterogeneity (PATCH): Trial of Dexamethasone Versus Methylprednisolone for Pediatric Critical Asthma
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
Who can join
Ages 3 to 17 · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- Dexamethasone (0.6mg/kg; Max 16mg) Once Daily (drug)
- Dexamethasone (0.25 mg/kg/dose, Max dose 16mg) every 6-hours (drug)
- Methylprednisolone (drug)
Sponsor: Johns Hopkins All Children's Hospital · Participants: 159 · Started: Aug 1, 2026
Contact the study team
- Meghan Sorondo, PharmD · Phone: 727-767-7044
Official record on ClinicalTrials.gov — NCT07455396
Locations in the U.S.
| Florida | Johns Hopkins All Children's Hospital, St. Petersburg |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.