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NCT07731217

Overview

NCT ID: NCT07731217
Lead Sponsor: Istanbul Medeniyet UniversityOTHER
Official Title: INTRAVENOUS DEXAMETHASONE VERSUS METHYLPREDNISOLONE IN WITH SEVERE ASTHMA EXACERBATION: A RANDOMISED, OPEN-LABEL, SINGLE-CENTRE STUDY
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

Status and Timeline

Status: Completed
Last Update Posted: Jul 28, 2026Actual
Start Date: Sep 1, 2025Actual
Primary Completion Date: Jul 1, 2026Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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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Study Plan

Study Type: Interventional
Phase: Phase 4
Enrollment: 129Actual
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: No data available
Locations: Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital

Similar Studies

Participant Group/Arms

Intravenous DexamethasoneExperimental

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 MethylprednisoloneActive 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