Recruiting
Phase 2

Dexamethasone & Methylprednisolone

Sponsor:

Johns Hopkins All Children's Hospital

Code:

NCT07455396

Conditions

Asthma (Diagnosis)

Eligibility Criteria

Sex: All

Age: 3 - 17

Healthy Volunteers: Not accepted

Interventions

Dexamethasone (0.6mg/kg; Max 16mg) Once Daily

Dexamethasone (0.25 mg/kg/dose, Max dose 16mg) every 6-hours

Methylprednisolone

Study Details

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.

Conditions

Asthma (Diagnosis)

Study ID

NCT07455396

Start date

Aug 1, 2026

Status verified date

Aug, 2026

Completion date

Aug 14, 2028

Anticipated

Primary completion date

Aug 14, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

159 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Dexamethasone Once Daily Dosing for 2days

Dexamethasone Intravenous 0.6mg/kg/dose once daily for two days (Max Dose: 16mg)

active comparator: Dexamethasone Every 6-Hours Dosing for 2 days

Dexamethasone 0.25mg/kg/dose every 6-hours for 8-total doses (i.e., 2 days) Max Dose 16mg per administration

active comparator: Methylprednisolone Every 6-hours Dosing for 5-days

Methylprednisolone 1mg/kg every 6-hours for 5-days

Interventions

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

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

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

Primary outcome measure

  • Post-Discharge Systemic Corticosteroid Exposure [ Time Frame: Within 30 days of hospital discharge ]
  • Cumulative Adverse Events of Special Interest [ Time Frame: From enrollment through 30-days following hospital discharge ]

Central Contacts and Locations

Central contacts

Meghan Sorondo, PharmD

727-767-7044mroddy4@jhmi.edu

Locations

Johns Hopkins All Children's Hospital

Recruiting

St. Petersburg, Florida, United States, 33701

Contacts

Meghan Sorondo, PharmD

727-767-7044mroddy4@jhmi.edu

Anthony Sochet, MD, MSc

7277672912sochet@jh.edu

Principal Investigator:

Meghan Sorondo, PharmD

More Information

Sponsor

Johns Hopkins All Children's Hospital

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Keywords

  • pediatric critical asthma
  • pediatric intensive care unit
  • status asthmaticus
  • systemic corticosteroids
  • methylprednisolone
  • dexamethasone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins All Children's Hospital on 2026-08-12.