Dexamethasone Versus Prednisolone in Acute Exacerbation of Childhood Asthma

NCT07275593 | Completed

• 1 other identifier: DR-ASIF-MULTAN
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief Summary

Because of insufficient local comparative data, this study was designed to determine the outcome of intravenous dexamethasone in contrast to oral prednisolone in acute exacerbation of asthmatic children.

Conditions

Acute Exacerbation of Asthma

Outcome Measures

Primary Outcomes (1)

• Asthma exacerbation

  The Pediatric Respiratory Assessment Measure (PRAM) score was used to assess the severity of asthma exacerbation. This score consisted of 5 items and had a maximum score of 12: suprasternal retractions (0-2), scalene muscle contraction (0-2), air entry in chest (0-3), wheeze (0-3), and oxygen saturation (0-2). A score of 1-3 showed mild exacerbation, 4-7 showed moderate exacerbation, and 8-12 revealed severe exacerbation of asthma.

  4 days

Study Arms (2)

Intravenous Dexamethasone Group

EXPERIMENTAL

Patients received a single IV dose of dexamethasone at a dose of 0.6 mg/kg.

Drug: Dexamethasone

Oral Prednisone Group

EXPERIMENTAL

Patients were given oral prednisone at a dose of 2 mg/kg/day (max 60 mg) as a single dose for 3 days.

Drug: Prednisolone

Interventions

Prednisolone DRUG

Patients received oral prednisone at a dose of 2 mg/kg/day (max 60 mg) as a single dose for 3 days.

Oral Prednisone Group

Dexamethasone DRUG

Patients received single IV dose of Dexamethasone at a dose of 0.6 mg/kg

Intravenous Dexamethasone Group

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children of any gender
• Aged 2-12 years
• Presenting with acute exacerbation of asthma within 24-hours

You may not qualify if:

• Children with PRAM score of ≥ 10
• Used oral or parenteral corticosteroids in last 4-weeks
• With any chronic condition of lungs (TB, cystic fibrosis), liver (chronic liver disease), kidneys (chronic kidney disease, nephrotic syndrome) or blood (thalassemia, malignancy)

Sponsors & Collaborators

• Muhammad Aamir Latif: lead

Study Sites (1)

Nishtar Medical University Hospital

Multan, Punjab Province, 66000, Pakistan

Location

MeSH Terms

Interventions

Dexamethasone; Prednisolone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Asif Abrar

  Nishter Hospital Multan, Pakistan

  PRINCIPAL INVESTIGATOR

• Azam Khan

  Nishter Hospital Multan, Pakistan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Consultant

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 10, 2025
• Study Start: November 3, 2024
• Primary Completion: April 3, 2025
• Study Completion: April 3, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)