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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: Clinical Trial Phase 2 study, sponsored by Johns Hopkins All Children's Hospital.
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, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Aggregate occurrence rate (i.e., risk) of systemic corticosteroid exposures after hospital discharge
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 |
What is known before NCT07455396 opens enrollment
NCT07455396 is an interventional study that assigns participants to a tested intervention. The registered 159 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% higher).
The record links to 0 conditions, and to 3 interventions - of which Methylprednisolone is the first listed.
NCT07455396 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07455396's enrollment target sits among peer trials
159 442nd of 2000 higher than 1,558 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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