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

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).

Study Overview

• Status: Unknown
• Conditions: Steroids In Management Of Acute Asthma Exacerbations
• Intervention / Treatment: Drug: Dexamethasone 8Mg Solution for Injection; Drug: Prednisolone Oral, Per 5 Mg

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71511
    • Assiut University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dexamethasone; 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).	Drug: Dexamethasone 8Mg Solution for Injection; 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
Experimental: prednisolone; 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 .	Drug: Prednisolone Oral, Per 5 Mg; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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) .	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.

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Chair: Moustafa M. El-Saied, Ph.D.of pediatrics, Assiut University -Faculty of medecin( Pediaric department)

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): April 30, 2017
• Study Completion (Anticipated): February 28, 2018

Study Registration Dates

• First Submitted: June 22, 2017
• First Submitted That Met QC Criteria: June 29, 2017
• First Posted (Actual): July 2, 2017

Study Record Updates

• Last Update Posted (Actual): January 12, 2018
• Last Update Submitted That Met QC Criteria: January 10, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone; Prednisolone
• Other Study ID Numbers: Eman Alfy Ellia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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