search
Back to results

Steroids In The Management Of Acute Asthma Exacerbations In Children, Which Form Is More Suitable?

Primary Purpose

Steroids In Management Of Acute Asthma Exacerbations

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Dexamethasone 8Mg Solution for Injection
Prednisolone Oral, Per 5 Mg
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Steroids In Management Of Acute Asthma Exacerbations

Eligibility Criteria

2 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ages 2 to 16 years
  • Background history of asthma
  • Presentation with an asthma exacerbation requiring repeated salbutamol after 20 minutes.

Exclusion Criteria:

  • Less than 2 years old or over 16 years
  • Critical or life-threatening asthma
  • Known tuberculosis exposure
  • Active varicella or herpes simplex infection
  • Documented concurrent infection with Respiratory syncytial virus
  • Fever >39.5°C
  • Use of oral corticosteroids in the previous four weeks
  • Concurrent stridor
  • Significant co-morbid disease: lung, cardiac, immune, liver, endocrine, neurological or psychiatric

Sites / Locations

  • Assiut University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

dexamethasone

prednisolone

Arm Description

Dexamethasone is a long-acting glucocorticoid with a half-life of 36 to 72 hours . It has been used safely in children with croup and bacterial meningitis . It is well absorbed both orally and parenterally .Single dose of intramuscular dexamethasone (0.6 mg/kg to a maximum of 18 mg).

Prednisolone is relatively short acting with a half-life of 12 to 36 hours, thereby requiring daily dosing. Outpatient steroid therapy is effective once compliance is assured.. Prolonged treatment course, vomiting, and a bitter taste may reduce patient compliance with prednisolone. Oral prednisolone for 3 days (1 mg/kg to a maximum of 40 mg), given orally in two devided doses .

Outcomes

Primary Outcome Measures

The Pediatric Respiratory Assessment Measure (PRAM)
The Pediatric Respiratory Assessment Measure (PRAM) , a validated, responsive and reliable tool to determine asthma severity in children aged 2 to 16 years, appears to be the most appropriate as an application in the emergency care setting . The PRAM score consists of five components and has a maximum total of 12 points: suprasternal retractions (0 to 2), scalene muscle contraction (0 to 2), air entry (0 to 3), wheezing (0 to 3) and O2 saturation (0 to 2) .

Secondary Outcome Measures

Full Information

First Posted
June 22, 2017
Last Updated
January 10, 2018
Sponsor
Assiut University
search

1. Study Identification

Unique Protocol Identification Number
NCT03204760
Brief Title
Steroids In The Management Of Acute Asthma Exacerbations In Children, Which Form Is More Suitable?
Official Title
Steroids In The Management Of Acute Asthma Exacerbations In Children, Which Form Is More Suitable?
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
April 30, 2017 (Actual)
Study Completion Date
February 28, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to compare the efficacy of a single dose of intramuscular dexamethasone versus 3 days of twice-daily oral prednisolone in the management of mild to moderate asthma exacerbations in children and test whether this single dose of intramuscular dexamethasone 0.6 mg/kg (max. 18 mg) is equal to prednisolone 1 mg/kg/day (max. 40 mg) in the treatment of exacerbations of asthma in children, as measured by the Pediatric Respiratory Assessment Measure (PRAM).
Detailed Description
This study will be performed in Assiut university Children Hospital and will include patients with asthma exacerbations presented to the emergency department for three months. All children presenting to the emergency department with mild to moderate asthma exacerbations will be assessed to decide if the child needs treatment with salbutamol. Before starting treatment the Pediatric Respiratory Assessment Measure (PRAM), vital signs, and oxygen saturation will be recorded. Peak expiratory flow rate (PEFR) will also be recorded if the patient was 6 years or older. Children with mild to moderate asthma exacerbation will be given the first dose of salbutamol and will be reassessed after 20 min by the emergency department attending. If further salbutamol is needed, subjects automatically will receive the second dose 20 min apart and receive either single dose of intramuscular dexamethasone (0.6 mg/kg to a maximum of 18 mg) or oral prednisolone for 3 days (1 mg/kg to a maximum of 40 mg), given orally . A repeat physical examination will be performed, including oxygen saturation, vital signs, PRAM, PEFR after the 3rd dose of salbutamol and at the end of the third day to evaluate the effect of prednisolone and dexamethasone on the improvement of asthma scores. Patient compliance to prednisolone therapy for three days will be also recorded. This study will be performed in Pediatric hospital - Assiut university and will include patients with asthma exacerbations presented to the emergency department for three months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Steroids In Management Of Acute Asthma Exacerbations

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Children with mild to moderate asthma exacerbation will be given the first dose of salbutamol and will be reassessed after 20 min by the emergency department attending. If further salbutamol is needed, subjects automatically will receive the second dose 20 min apart and receive either single dose of intramuscular dexamethasone (0.6 mg/kg to a maximum of 18 mg) or prednisolone for 3 days (1 mg/kg to a maximum of 40 mg), given orally in two devided doses . A repeat physical examination will be performed, including oxygen saturation, vital signs, PRAM, PEFR after the 3rd dose of salbutamol and at the end of the third day to evaluate the effect of prednisolone and dexamethasone on the improvement of asthma scores. Patient compliance to prednisolone therapy for three days will be also recorded.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dexamethasone
Arm Type
Experimental
Arm Description
Dexamethasone is a long-acting glucocorticoid with a half-life of 36 to 72 hours . It has been used safely in children with croup and bacterial meningitis . It is well absorbed both orally and parenterally .Single dose of intramuscular dexamethasone (0.6 mg/kg to a maximum of 18 mg).
Arm Title
prednisolone
Arm Type
Experimental
Arm Description
Prednisolone is relatively short acting with a half-life of 12 to 36 hours, thereby requiring daily dosing. Outpatient steroid therapy is effective once compliance is assured.. Prolonged treatment course, vomiting, and a bitter taste may reduce patient compliance with prednisolone. Oral prednisolone for 3 days (1 mg/kg to a maximum of 40 mg), given orally in two devided doses .
Intervention Type
Drug
Intervention Name(s)
Dexamethasone 8Mg Solution for Injection
Intervention Description
Effect single dose of intramuscular dexamethasone (0.6 mg/kg to a maximum of 18 mg) in the treatment of mild to moderate acute asthma exacerbations in children
Intervention Type
Drug
Intervention Name(s)
Prednisolone Oral, Per 5 Mg
Intervention Description
Effect of prednisolone for 3 days (1 mg/kg to a maximum of 40 mg), given orally in two devided doses in the treatment of mild to moderate acute asthma exacerbations in children.
Primary Outcome Measure Information:
Title
The Pediatric Respiratory Assessment Measure (PRAM)
Description
The Pediatric Respiratory Assessment Measure (PRAM) , a validated, responsive and reliable tool to determine asthma severity in children aged 2 to 16 years, appears to be the most appropriate as an application in the emergency care setting . The PRAM score consists of five components and has a maximum total of 12 points: suprasternal retractions (0 to 2), scalene muscle contraction (0 to 2), air entry (0 to 3), wheezing (0 to 3) and O2 saturation (0 to 2) .
Time Frame
PRAM score is assessed at the end of the third day to evaluate the effect of prednisolone and dexamethasone on the improvement of asthma scores.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ages 2 to 16 years Background history of asthma Presentation with an asthma exacerbation requiring repeated salbutamol after 20 minutes. Exclusion Criteria: Less than 2 years old or over 16 years Critical or life-threatening asthma Known tuberculosis exposure Active varicella or herpes simplex infection Documented concurrent infection with Respiratory syncytial virus Fever >39.5°C Use of oral corticosteroids in the previous four weeks Concurrent stridor Significant co-morbid disease: lung, cardiac, immune, liver, endocrine, neurological or psychiatric
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moustafa M. El-Saied, Ph.D.of pediatrics
Organizational Affiliation
Assiut University -Faculty of medecin( Pediaric department)
Official's Role
Study Chair
Facility Information:
Facility Name
Assiut University
City
Assiut
ZIP/Postal Code
71511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Steroids In The Management Of Acute Asthma Exacerbations In Children, Which Form Is More Suitable?

We'll reach out to this number within 24 hrs