IV DEXAMETHASONE VS. METHYLPREDNISOLONE IN CHILDREN WITH SEVERE ASTHMA EXACERBATION

NCT07731217 | Completed Phase 4

• 1 other identifier: 2025/0050
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to determine whether a two-day intravenous course of dexamethasone is non-inferior to a conventional five-day intravenous course of methylprednisolone in children presenting with severe asthma exacerbations. To answer this question, researchers randomly assign eligible children to receive either IV dexamethasone or IV methylprednisolone. The clinical response to the treatments is objectively evaluated and compared using the Pediatric Respiratory Assessment Measure (PRAM) score at the 4th hour of treatment and on the 2nd day following hospital discharge.

Conditions

Status Asthmaticus; Asthma (Diagnosis); Asthma Exacerbations

Keywords

PRAM score; Severe Asthma Exacerbation; Acute Asthma; Dexamethasone; Methylprednisolone

Outcome Measures

Primary Outcomes (2)

• PRAM (Pediatric Respiratory Assessment Measure) Score at 4th Hour

  The PRAM score is a validated clinical scoring system used to assess asthma severity in children. It evaluates clinical signs including suprasternal retractions, scalene muscle contraction, air entry, wheezing, and O2 saturation. The total score ranges from 0 to 12, with higher scores indicating more severe respiratory distress.

  At 4 hours after the initiation of treatment in the emergency department.

• PRAM Score on the 2nd Day Post-Discharge

  The PRAM score will be calculated to assess the patient's respiratory status during the follow-up visit. The total score ranges from 0 to 12, with higher scores indicating more severe respiratory distress.

  2 days after discharge from the hospital

Secondary Outcomes (6)

• Total Number of Salbutamol Doses

  Up to 14 days post-discharge.

• Hospitalization Rate

  Up to 4 hours post-treatment initiation in the emergency department.

• Length of Hospital Stay

  From hospital admission to hospital discharge (an expected average of 2 to 5 days)

• Rate of Re-presentation to the Hospital

  Within 14 days post-discharge

• Re-hospitalization Rate

  Within 14 days post-discharge

Study Arms (2)

Intravenous Dexamethasone

EXPERIMENTAL

Patients in this arm will receive intravenous dexamethasone at a dose of 0.6 mg/kg/day (maximum 16 mg/day), divided every 12 hours, for a total of 2 days. This is administered in addition to the standard emergency asthma exacerbation treatment.

Drug: Intravenous Dexamethasone

Intravenous Methylprednisolone

ACTIVE COMPARATOR

Patients in this arm will receive intravenous methylprednisolone at a dose of 2 mg/kg/day (maximum doses: 30 mg/day for 2-5 years; 60 mg/day for 5-12 years; 80 mg/day for ≥12 years), divided every 12 hours, for a total of 5 days. This is administered in addition to the standard emergency asthma exacerbation treatment.

Drug: Intravenous Methylprednisolone

Interventions

Intravenous Dexamethasone DRUG

Patients assigned to this intervention will receive intravenous dexamethasone at a dosage of 0.6 mg/kg/day. The total daily dose will be divided and administered every 12 hours. The maximum allowable dose is 16 mg/day, and the total duration of this treatment protocol is 2 days. If a patient is discharged from the hospital before the completion of the 2-day steroid protocol, the remaining treatment will be completed orally at home.

Intravenous Dexamethasone

Intravenous Methylprednisolone DRUG

Patients assigned to this intervention will receive intravenous methylprednisolone at a dosage of 2 mg/kg/day. The total daily dose will be divided and administered every 12 hours. The maximum daily dose is age-dependent (30 mg/day for children aged 2-5 years; 60 mg/day for children aged 5-12 years; and 80 mg/day for children aged 12 years and older). The total duration of this standard treatment protocol is 5 days. If a patient is discharged from the hospital before the completion of the 5-day steroid protocol, the remaining treatment will be completed oral

Intravenous Methylprednisolone

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• History of receiving salbutamol ± steroid treatment for two or more previous wheezing attacks, OR physician-diagnosed asthma.
• Patients admitted to the Pediatric Emergency Department due to severe asthma exacerbation (Pediatric Respiratory Assessment Measure \[PRAM\] score ≥8).

You may not qualify if:

• Patients with concurrent croup.
• Presence of comorbidities (cardiovascular, neurological, malignancy, chronic kidney or lung disease).
• Patients with pneumonia.
• Patients with air leaks (pneumothorax, pneumomediastinum).
• Patients requiring immediate Intensive Care Unit (ICU) admission.
• Systemic steroid use within the last 8 weeks.
• Failure to obtain informed consent.

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Status Asthmaticus; Asthma; Disease

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Lung Diseases, Obstructive; Lung Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 28, 2026
• Study Start: September 1, 2025
• Primary Completion: July 1, 2026
• Study Completion: July 15, 2026
• Last Updated: July 28, 2026

Record last verified: 2026-07

Locations

TU (1)