Dexamethasone Versus Prednisolone in Acute Exacerbation of Childhood Asthma

NCT ID: NCT07275593

Last Updated: 2025-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-03

Study Completion Date

2025-04-03

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Exacerbation of Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intravenous Dexamethasone Group

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

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Prednisolone

Intervention Type DRUG

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

Interventions

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Dexamethasone

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

Intervention Type DRUG

Prednisolone

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

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Muhammad Aamir Latif

OTHER

Sponsor Role lead

Responsible Party

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Muhammad Aamir Latif

Research Consultant

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Asif Abrar

Role: PRINCIPAL_INVESTIGATOR

Nishter Hospital Multan, Pakistan

Azam Khan

Role: STUDY_DIRECTOR

Nishter Hospital Multan, Pakistan

Locations

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Nishtar Medical University Hospital

Multan, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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DR-ASIF-MULTAN

Identifier Type: -

Identifier Source: org_study_id

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