NCT07455396 Pediatric Asthma Trial of Corticosteroid Heterogeneity (PATCH): Trial of Dexamethasone Versus Methylprednisolone for Pediatric Critical Asthma
| NCT ID | NCT07455396 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Johns Hopkins All Children's Hospital |
| Condition | Asthma (Diagnosis) |
| Study Type | INTERVENTIONAL |
| Enrollment | 159 participants |
| Start Date | 2026-08-01 |
| Primary Completion | 2028-08-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 159 participants in total. It began in 2026-08-01 with a primary completion date of 2028-08-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Meghan Sorondo, PharmD
PRINCIPAL INVESTIGATOR
Johns Hopkins All Children's Hospital
Frequently Asked Questions
Who can join the NCT07455396 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 17 Years, studying Asthma (Diagnosis). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07455396 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07455396 currently recruiting?
Yes, NCT07455396 is actively recruiting participants. Contact the research team at mroddy4@jhmi.edu for enrollment information.
Where is the NCT07455396 trial being conducted?
This trial is being conducted at St. Petersburg, United States.
Who is sponsoring the NCT07455396 clinical trial?
NCT07455396 is sponsored by Johns Hopkins All Children's Hospital. The principal investigator is Meghan Sorondo, PharmD at Johns Hopkins All Children's Hospital. The trial plans to enroll 159 participants.
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