A trial to investigate if a single dose of the oral corticosteroid, Dexamethasone is as effective in treating exacerbations of asthma in children as 3 days of treatment with another oral corticosteroid, Prednisolone

• Conditions: Exacerbation of asthma in children presenting to the Emergency Department; MedDRA version: 13.1Level: LLTClassification code 10003566Term: Asthmatic attackSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 13.1Level: LLTClassification code 10015575Term: Exacerbation of asthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2010-022001-18-IE
• Lead Sponsor: niversity College Dublin Clinical Research Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-05
• Last Update Posted: 22 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 232

Inclusion Criteria

•Ages 2 – 16 years

•Background history of asthma.
Asthma for the purpose of this study will be defined as either: at least one previous episode of ß2-agonist-responsive wheeze in a child two years of age or over; or a prior diagnosis of asthma, made by a paediatrician, or clinician of comparable experience.

•Presentation with an asthma exacerbation
An exacerbation of asthma, for the purpose of this study, will be defined as acute asthma which prompts assessment at the Emergency Department, and has any, or all, of the following clinical features:
o Dyspnoea
o Wheeze
o Acute cough
o Increased work of breathing
o Increased requirement for ß2-agonist from baseline use
o SpO2 <95%

Are the trial subjects under 18? yes
Number of subjects for this age range: 232
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Less than 2 years old or over 16 years

•Critical or life-threatening asthma, defined as patients displaying one or more of the following clinical features:
o Confused/drowsy
o Maximal accessory muscle use/recession
o Poor respiratory effort (including bradypnoea)
o Exhaustion
o Silent chest
o Cyanosis
o O2 saturation < 90% in air
o Marked tachycardia
o Unable to verbalise normally
o Pneumothorax

•Known TB exposure

•Active varicella or herpes simplex infection

•Documented concurrent infection with RSV

•Fever >39.5 degrees Celcius

•Use of oral corticosteroids in the previous 4 weeks

•Concurrent stridor

•Significant co-morbid disease:
Lung, cardiac, immune, liver, endocrine, neurological or psychiatric

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified