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

NCT07455396 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2026-08-12

No results posted yet for this study

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.

Conditions

  • Asthma (Diagnosis)

Interventions

DRUG

Dexamethasone (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

DRUG

Dexamethasone (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

DRUG

Methylprednisolone

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

Sponsors & Collaborators

  • Johns Hopkins All Children's Hospital

    lead OTHER

Principal Investigators

  • Meghan Sorondo, PharmD · Johns Hopkins All Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2028-08-14
Completion
2028-08-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07455396 on ClinicalTrials.gov