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

Part of paid clinical trials in St. Petersburg, Florida.

Sponsor
Johns Hopkins All Children's Hospital
Study ID
NCT07455396
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Asthma (Diagnosis)

Eligibility Criteria

Sex
ALL
Age
3 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Dexamethasone (0.6mg/kg; Max 16mg) Once Daily — DRUG
    For 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 — DRUG
    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
  • Methylprednisolone — DRUG
    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

Study Details

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.

Key Dates

Start date
May 15, 2026
Status verified
Mar 2026
Primary completion
May 14, 2028
Completion
May 14, 2028

Study Design

Enrollment
159 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Dexamethasone Once Daily Dosing for 2days
    Dexamethasone Intravenous 0.6mg/kg/dose once daily for two days (Max Dose: 16mg)
  • Active Comparator: Dexamethasone Every 6-Hours Dosing for 2 days
    Dexamethasone 0.25mg/kg/dose every 6-hours for 8-total doses (i.e., 2 days) Max Dose 16mg per administration
  • Active Comparator: Methylprednisolone Every 6-hours Dosing for 5-days
    Methylprednisolone 1mg/kg every 6-hours for 5-days

Primary Outcome Measure

Post-Discharge Systemic Corticosteroid Exposure [ Time Frame: Within 30 days of hospital discharge ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins All Children's HospitalSt. PetersburgFlorida33701
Meghan Sorondo, PharmD
[email protected]
727-767-7044
Anthony Sochet, MD, MSc
[email protected]
7277672912
Meghan Sorondo, PharmD (PRINCIPAL_INVESTIGATOR)

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