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Completed

NCT Number: NCT07731217

IV DEXAMETHASONE VS. METHYLPREDNISOLONE IN CHILDREN WITH SEVERE ASTHMA EXACERBATION

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.

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Key information

Conditions

Status Asthmaticus Asthma Asthma (Diagnosis) Asthma Exacerbations Bronchial Diseases Disease Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Aged between 2 and 18 years.

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).

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Exclusion criteria

Patients with suspected or confirmed foreign body aspiration.

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.

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Treatment and study plan

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 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

Primary outcomes

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

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

    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.

  2. PRAM Score on the 2nd Day Post-Discharge

    Time frame: 2 days after discharge from the hospital

    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.

Secondary outcomes

  1. Total Number of Salbutamol Doses

    Time frame: Up to 14 days post-discharge.

    The total number of short-acting beta-agonist (salbutamol) doses required by the patient after discharge.

  2. Hospitalization Rate

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

    The percentage of patients who require admission to the pediatric allergy ward or intensive care unit due to inadequate response to emergency treatment.

  3. Length of Hospital Stay

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

    The total duration the patient remains in the hospital (emergency department, ward, or ICU) from admission to discharge.

  4. Rate of Re-presentation to the Hospital

    Time frame: Within 14 days post-discharge

    The percentage of patients who return to the emergency department or outpatient clinic with a new or worsened asthma exacerbation.

  5. Re-hospitalization Rate

    Time frame: Within 14 days post-discharge

    The percentage of patients who require a new hospital admission due to asthma exacerbation after their initial discharge.

  6. Incidence of Adverse Events

    Time frame: Up to 14 days post-discharge

    The number of participants experiencing corticosteroid-related adverse events, including vomiting, hyperglycemia, gastrointestinal bleeding, and hypertension.

Sponsors and collaborators

Lead sponsor

Istanbul Medeniyet University

Other

Registry information

Official study title

INTRAVENOUS DEXAMETHASONE VERSUS METHYLPREDNISOLONE IN WITH SEVERE ASTHMA EXACERBATION: A RANDOMISED, OPEN-LABEL, SINGLE-CENTRE STUDY

Acronym: IV:INTRAVENOUS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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