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
Johns Hopkins All Children's Hospital
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.
Description
Acute asthma exacerbation is caused by dysregulated pulmonary inflammatory pathways such that standard treatment includes prompt administration of exogenous SCs.17 These agents placate the inflammatory process mediated by airway and systemic leukocytes and have been shown to improve the efficacy of nebulized bronchodilators (i.e., β-2 agonists).18-23 There remains an ongoing dialogue among the expert medical community regarding the superiority of specific SCs including dose, frequency of administration, route, and delivery. While the benefits of SCs for asthma exacerbation have been demonstrat…
Eligibility
- Age range
- 3–17 years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- DrugDexamethasone (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
- DrugDexamethasone (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
- DrugMethylprednisolone
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
Location
- Johns Hopkins All Children's HospitalSt. Petersburg, Florida