What this study is
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.
What's being tested
- Dexamethasone (0.6mg/kg; Max 16mg) Once Daily
Intervention · 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
Intervention · 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
Intervention · 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
- Official title
- Pediatric Asthma Trial of Corticosteroid Heterogeneity (PATCH): A Phase 2 Prospective Randomized Open Blinded End-point (PROBE) Design, Randomized Clinical Trial of Dexamethasone Versus Methylprednisolone for Pediatric Critical Asthma
- Sponsor
- Johns Hopkins All Children's Hospital
- Conditions
- Asthma (Diagnosis)
- Enrolling
- 159 people
- Starts
- 2026-08-01
- Est. completion
- 2028-08-14
- Design
- Single-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 3 Years – 17 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Age 3-17 years
- Intensive care unit admission
- Treatment for critical asthma
You can't join if
- History of unrepaired critical congenital heart disease
- History of cystic fibrosis
- Active tracheostomy dependence
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openJohns Hopkins All Children's Hospital
St. Petersburg, Florida, United States
- Meghan Sorondo, PharmD · Contact727-767-7044mroddy4@jhmi.edu
- Anthony Sochet, MD, MSc · Contact7277672912sochet@jh.edu
- Meghan Sorondo, PharmD · Principal investigator
Recruiting
Study team
Sponsor
Johns Hopkins All Children's Hospital
Study ID IRB00544439
Principal investigator
Meghan Sorondo, PharmD
Johns Hopkins All Children's Hospital
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.