Condition category
Respiratory
Date applied
27/04/2010
Date assigned
18/06/2010
Last edited
08/05/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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 measures

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

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 (Ireland)

Sponsor details

Our Lady's Children's Hospital
Crumlin
Dublin
12
Ireland
info@childrensresearchcentre.org

Sponsor type

Research organisation

Website

http://www.childrensresearchcentre.org/index.html

Funders

Funder type

Research organisation

Funder name

National Children's Research Centre (Ireland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22909281

Publication citations

  1. 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.

Additional files

Editorial Notes