Pediatric Asthma Trial of Corticosteroid Heterogeneity (PATCH): 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…
Conditions studied
Asthma (Diagnosis)
About this 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.
Interventions
- 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
- 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
- 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
Primary outcomes
- Post-Discharge Systemic Corticosteroid Exposure (Within 30 days of hospital discharge)
- Cumulative Adverse Events of Special Interest (From enrollment through 30-days following hospital discharge)
Eligibility information
Study locations
- Johns Hopkins All Children's Hospital, St. Petersburg, Florida 33701 United States
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.