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NCT07455396 · ClinicalTrials.gov registry record · Phase 2
Pediatric Asthma Trial of Corticosteroid Heterogeneity (PATCH): Trial of Dexamethasone Versus Methylprednisolone for Pediatric Critical Asthma
A Phase 2 study, sponsored by Johns Hopkins All Children's Hospital.
- Not yet
- Registry status
- Phase 2
- Development phase
- 159
- Enrollment target
NCT07455396 is a Phase 2 study that has not yet begun recruiting, run by Johns Hopkins All Children's Hospital. The registered enrollment target is 159 participants.
The verdict
NCT07455396, a Phase 2 study, has not yet begun recruiting, sponsored by Johns Hopkins All Children's Hospital.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 159 participants
- Enrollment target
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.
Interventions
- DRUG Methylprednisolone
- DRUG Dexamethasone (0.6mg/kg; Max 16mg) Once Daily
- DRUG Dexamethasone (0.25 mg/kg/dose, Max dose 16mg) every 6-hours
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 159 participants |
| Start Date | 2026-05-15 |
| Est. Completion | 2028-05-14 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07455396
The ClinicalTrials.gov registry entry for NCT07455396 describes a study currently listed as not yet recruiting, categorized as Phase 2. The registered enrollment target is 159 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins All Children's Hospital, which has 24 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Methylprednisolone is the first listed.
NCT07455396 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07455396 about?
NCT07455396 is a clinical study titled "Pediatric Asthma Trial of Corticosteroid Heterogeneity (PATCH): Trial of Dexamethasone Versus Methylprednisolone for Pediatric Critical Asthma". 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 ...
What is the current status of trial NCT07455396?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 159 participants. The study started on 2026-05-15. Estimated completion is 2028-05-14.
What interventions are being tested in trial NCT07455396?
The interventions under investigation include: Methylprednisolone (DRUG), Dexamethasone (0.6mg/kg; Max 16mg) Once Daily (DRUG), Dexamethasone (0.25 mg/kg/dose, Max dose 16mg) every 6-hours (DRUG).
Who is sponsoring clinical trial NCT07455396?
This trial is sponsored by Johns Hopkins All Children's Hospital, which has 24 total clinical trials registered on ClinicalTrials.gov.
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