Dexamethasone Versus Prednisolone in Acute Exacerbation of Childhood Asthma

November 27, 2025 updated by: Muhammad Aamir Latif

Comparison of Outcome Between Dexamethasone Versus Prednisolone Administration in Acute Exacerbation of Childhood Asthma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The findings of this study would furnish the local data. The results would also provide recommendations to use more appropriate steroid options in the local settings, resulting in aid to improve the quality of life of asthmatic children and their quicker return to daily routine activities.

Study Type

Interventional

Enrollment (Actual)

224

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Multan, Punjab Province, Pakistan, 66000
        • Nishtar Medical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intravenous Dexamethasone Group
Patients received a single IV dose of dexamethasone at a dose of 0.6 mg/kg.
Drug: Dexamethasone
Patients received single IV dose of Dexamethasone at a dose of 0.6 mg/kg
Experimental: Oral Prednisone Group
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
Patients received oral prednisone at a dose of 2 mg/kg/day (max 60 mg) as a single dose for 3 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asthma exacerbation
Time Frame: 4 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Muhammad Aamir Latif

Investigators

  • Principal Investigator: Asif Abrar, Nishter Hospital Multan, Pakistan
  • Study Director: Azam Khan, Nishter Hospital Multan, Pakistan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2024

Primary Completion (Actual)

April 3, 2025

Study Completion (Actual)

April 3, 2025

Study Registration Dates

First Submitted

November 27, 2025

First Submitted That Met QC Criteria

November 27, 2025

First Posted (Actual)

December 10, 2025

Study Record Updates

Last Update Posted (Actual)

December 10, 2025

Last Update Submitted That Met QC Criteria

November 27, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DR-ASIF-MULTAN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data can be shared on a reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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