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.
Age 3-17 years
Intensive care unit admission
Treatment for critical asthma
History of unrepaired critical congenital heart disease
History of cystic fibrosis
Active tracheostomy dependence
Parallel
Dexamethasone (0.6mg/kg; Max 16mg) Once Daily
DrugFor this intervention, Dexamethasone will be administered at 0.6mg/kg/dose once daily for a maximum dose of 16 mg for 2 days
Dexamethasone (0.25 mg/kg/dose, Max dose 16mg) every 6-hours
DrugFor this intervention, Dexamethasone will be administered at 0.25mg/kg/dose every 6 hours for a maximum dose of 16 mg for 2 days
Methylprednisolone
DrugFor this intervention, Methylprednisolone will be administered at 1 mg/kg/dose every 6 hours for a maximum dose of 60 mg for 5 days
Post-Discharge Systemic Corticosteroid Exposure
Aggregate occurrence rate (i.e., risk) of systemic corticosteroid exposures after hospital discharge
Cumulative Adverse Events of Special Interest
Cumulative Adverse Events of Special Interest are inclusive of symptomatic hypertension requiring an antihypertensive agent, symptomatic hyperglycemia requiring insulin, symptomatic agitation requiring antipsychotic agent or sedative administration, adrenal insufficiency, and candidiasis.
Pediatric Asthma Quality of Life
Pediatric Asthma Quality of Life Questionnaire. Mean scores range from 1 to 7. Higher score indicating higher quality of life.
Critical Asthma Adjunct Intervention Free Hours
Critical Asthma Adjunct Intervention Free Hours includes the cumulative number of hours during hospitalization where no critical asthma adjunct interventions are administered.
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