NCT07455396 — drugset

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.

Timeline

Start: 2026-08-01
Primary completion: 2028-08-14
Completion: 2028-08-14

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Dexamethasone	Small molecule	0.25 mg/kg	Intravenous
Comparator	Dexamethasone	Small molecule	0.6 mg/kg	Intravenous
Comparator	Methylprednisolone	Other / unclassified	1 mg/kg	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications