Contact information
Type
Scientific
Primary contact
Prof Ronan O'Sullivan
ORCID ID
Contact details
Paediatric Emergency Research Unit
Department of Emergency Medicine
Our Lady's Children's Hospital
Crumlin
Dublin
12
Ireland
-
ronan.osullivan@olchc.ie
Additional identifiers
EudraCT number
2010-022001-18
ClinicalTrials.gov number
NCT03698630
Protocol/serial number
N/A
Study information
Scientific title
A randomised trial of single dose oral dexamethasone versus multi-dose prednisolone in the treatment of acute exacerbations of asthma in children who attend the Emergency Department
Acronym
Study hypothesis
Asthma is a major cause of paediatric morbidity and mortality. In acute exacerbations of asthma, corticosteroids reduce relapses, subsequent hospital admission and the need for beta-2 agonist therapy. The earlier corticosteroids are administered in an acute episode, the better the clinical outcome. In the 2008 British Guidelines on the Management of Asthma, the British Thoracic Society (BTS) recommends commencing oral prednisolone early for children presenting with exacerbations of asthma and if discharged, continuing treatment for up to three days.
Prednisolone is relatively short acting with a half-life of 12 to 36 hours, requiring daily dosing. Outpatient steroid therapy is effective once compliance is assured. However, many factors impact on patient compliance with medication. One study found that at least 7% of children seen in a paediatric ED never have their prescriptions filled. Prolonged treatment course, vomiting and in particular a bitter taste may reduce patient compliance with prednisolone. If effective, a single dose of corticosteroid would remove the problem of poor compliance and therefore reduce morbidity and the risk of relapse.
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, but is not specifically mentioned in the British Guideline on the Management of Asthma in children. It is well absorbed both orally and parenterally. Whereas intramuscular dexamethasone is invasive but ensures compliance, a single dose of oral dexamethasone would negate the need for an injection and retain the advantage of ensuring compliance.
The proposed trial will examine whether a single dose of oral dexamethasone phosphate (0.3 mg/kg) is non-inferior to prednisolone (1 mg/kg/day for 3 days) in the treatment of exacerbations of asthma of all levels of severity in children who attend the ED. This dosing regime is more reflective of current prescribing practices in paediatric emergency medicine in the UK and Ireland and also in Australasia.
Ethics approval
Ethics Committee of Our Lady's Children's Hospital, pending as of 27/04/2010
Study design
Single centre randomised double-blind non-inferiority clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Asthma
Intervention
Dexamethasone phosphate 0.3 mg/kg orally (PO) followed by one placebo dose daily for 2 days (3 doses in total) or prednisolone 1 mg/kg/day PO for 3 days.
Dexamethasone is licensed for use in the Republic of Ireland in a liquid or tablet form. The liquid preparation is available as a 2 mg/5 ml solution with a 150 ml bottle costing 80.18. The tablet preparation is available as a crushable 2 mg tablet costing 14.96 for a 100-tab pack. Prednisolone is available as dispersible 5 mg tablets costing 7.85 for a 20-tablet pack.
It is estimated that the study duration will be approximately 18 months.
Intervention type
Drug
Phase
Phase II
Drug names
Dexamethasone phosphate, prednisolone
Primary outcome measure
Exacerbations of asthma, as measured by the Pediatric Respiratory Assessment Measure (PRAM), measured at enrolment, pre-ED discharge (4 hours) and at 4 days.
Secondary outcome measures
1. Relapse rates, measured at 4 and 14 days
2. Treatment cost
Overall trial start date
01/07/2010
Overall trial end date
31/12/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 2 - 16 years, either sex
2. Presentation with acute asthma, defined as:
2.1. At least two previous episodes of beta-2-agonist responsive wheeze in a child 2 years of age or over
2.2. A prior diagnosis of asthma, made by a paediatrician, or clinician of comparable experience
3. Present to the ED of Our Ladys Childrens Hospital, Crumlin (OLCHC), Dublin, Ireland
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
286 participants
Participant exclusion criteria
1. Less than 2 years old or over 16 years
2. Previous enrolment in the study
3. Critical or life threatening asthma
4. Known tuberculosis (TB) exposure
5. Active varicella or herpes simplex infection
6. History of acute allergic reaction
7. Documented concurrent infection with respiratory syncytial virus (RSV)
8. Fever greater than 39.5°C
9. Use of oral corticosteroids or admission for asthma in the previous 4 weeks
10. Concurrent stridor
11. Possible intrathoracic foreign body
12. Significant co-morbid disease, i.e., lung, cardiac, immune, liver, endocrine, neurological or psychiatric
Recruitment start date
01/07/2010
Recruitment end date
31/12/2011
Locations
Countries of recruitment
Ireland
Trial participating centre
Paediatric Emergency Research Unit
Dublin
12
Ireland
Sponsor information
Organisation
National Children’s Research Centre
Sponsor details
Our Lady's Children's Hospital
Crumlin
Dublin
12
Ireland
-
info@childrensresearchcentre.org
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
National Children's Research Centre
Alternative name(s)
NCRC
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit
Location
Ireland
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
https://www.clinicaltrialsregister.eu/ctr-search/trial/2010-022001-18/results (added 28/05/2020)
Publication list
1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22909281
Publication citations
-
Protocol
Cronin J, Kennedy U, McCoy S, An Fhailí SN, Crispino-O'Connell G, Hayden J, Wakai A, Walsh S, O'Sullivan R, Single dose oral dexamethasone versus multi-dose prednisolone in the treatment of acute exacerbations of asthma in children who attend the emergency department: study protocol for a randomized controlled trial., Trials, 2012, 13, 141, doi: 10.1186/1745-6215-13-141.