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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age3-17
SponsorJohns Hopkins All Children's Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Age 3-17 years

Intensive care unit admission

Treatment for critical asthma

Disqualifiers

History of unrepaired critical congenital heart disease

History of cystic fibrosis

Active tracheostomy dependence

Trial design

Treatments tested in this trial

  • Dexamethasone (0.6mg/kg; Max 16mg) Once Daily
  • Dexamethasone (0.25 mg/kg/dose, Max dose 16mg) every 6-hours
  • Methylprednisolone

Treatment groups

159 Participants
are divided into 3 treatment groups