EFFECTIVENESS OF SINGLE DOSE ORAL DEXAMETHASONE VERSUS MULTIDOSE PREDNISOLONE FOR TREATMENT OF ACUTE EXACERBATIONS OF ASTHMA AMONG CHILDREN ATTENDING THE EMERGENCY DEPARTMENT OF CHILDREN HOSPITAL, ISLAMABAD

May 8, 2023 updated by: DR. MOHAMMAD ALI ARIF
In this Study i'll compare the effectiveness of two drugs used in acute exacerbation of asthma by their sideffects, complaince and improvement in the PRAM score. The better one would be adapted in our clinical practice.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

192

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
      • Islamabad, Pakistan, 46000
        • Asim Nawaz Niazi

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:

  • i.Ages 2 to 12years ii. Previous history of asthma as diagnosed by a physician. iii. Presentation with acute exacerbation of asthma with symptoms of cough, wheeze, dyspnoea and oxygen saturation of less than 95% and with PRAM score of more than or equal to 6

Exclusion Criteria:

  • i.Critical or life-threatening asthma i.e. patient with silent chest, cyanosis, drowsy, unable to verbalize, marked tachycardia and respiratory distress. ii.Known TB exposure iii.Fever more than 39. 5°C iv.Use of corticosteroids in previous 4 weeks v.Significant co-morbid disease: lung, cardiac, immune, liver, endocrine, neurological or psychiatric

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: Other
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Oral Single dose dexamethsone in acute exacerbation of asthma
Drug: Dexamethasone
Oral Dexamethasone a longer and potent corticosteroid with lesser sideffects and good compliance
Active Comparator: Oral Multidose Prednisolone in acute exacerbation of asthma
Drug: Prednisolone
Oral Multidose Prednisolone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in PRAM score
Time Frame: 4 days
PRAM will be evaluated at day 4
4 days

Collaborators and Investigators

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

Sponsor

DR. MOHAMMAD ALI ARIF

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)

January 26, 2019

Primary Completion (Anticipated)

December 26, 2023

Study Completion (Anticipated)

December 26, 2023

Study Registration Dates

First Submitted

April 28, 2023

First Submitted That Met QC Criteria

May 8, 2023

First Posted (Actual)

May 9, 2023

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERB/SZABMU/2021-192

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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