Clinical Trial

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

Study acronym: PATCH
Recruiting Phase 2
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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.
Protocol Amendment History 3 changes
critical Recruitment opened 2026-08-13
notable Primary completion pushed: 2028-05-14 -> 2028-08-14 2026-07-16
minor Completion pushed: 2028-05-14 -> 2028-08-14 2026-07-16
Trial Details
NCT Number NCT07455396
Lead Sponsor Johns Hopkins All Children's Hospital
Conditions Asthma (Diagnosis)
Enrollment 159 participants
Start Date 2026-08-01
Primary Completion 2028-08-14 (estimated)
Study Completion 2028-08-14 (estimated)
Updated on ClinicalTrials.gov 2026-08-12