Is a single dose of steroids no worse than multiple doses in treating acute asthma episodes in children?

ISRCTN	ISRCTN26944158
DOI	https://doi.org/10.1186/ISRCTN26944158
EudraCT/CTIS number	2010-022001-18
ClinicalTrials.gov number	NCT03698630
Secondary identifying numbers	N/A

Submission date: 27/04/2010
Registration date: 18/06/2010
Last edited: 28/05/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Ronan O'Sullivan
Scientific

Paediatric Emergency Research Unit
Department of Emergency Medicine
Our Lady's Children's Hospital
Crumlin
Dublin
12
Ireland

Email	ronan.osullivan@olchc.ie

Study information

Study design	Single centre randomised double-blind non-inferiority clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	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(s)	Ethics Committee of Our Lady's Children's Hospital, pending as of 27/04/2010
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase II
Drug / device / biological / vaccine name(s)	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 study start date	01/07/2010
Completion date	31/12/2011

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	2 Years
Upper age limit	16 Years
Sex	Both
Target number of participants	286 participants
Key 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
Key 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
Date of first enrolment	01/07/2010
Date of final enrolment	31/12/2011

Locations

Countries of recruitment

Ireland

Study participating centre

Paediatric Emergency Research Unit

Dublin
12
Ireland

Sponsor information

National Children’s Research Centre
Research organisation

Our Lady's Children's Hospital
Crumlin
Dublin
12
Ireland

Email	info@childrensresearchcentre.org
Website	http://www.childrensresearchcentre.org/index.html
"ROR"	https://ror.org/02typaz40

Funders

Funder type

Research organisation

National Children's Research Centre
Government organisation / Research institutes and centers

Alternative name(s): NCRC
Location: Ireland

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	21/08/2012		Yes	No
Basic results			28/05/2020	No	No

Editorial Notes

28/05/2020: Added clinicaltrialsregister.eu link to basic results (scientific).
13/02/2020: ClinicalTrials.gov number added.