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 |
| ClinicalTrials.gov (NCT) | NCT03698630 |
| Clinical Trials Information System (CTIS) | 2010-022001-18 |
| Protocol serial number | N/A |
| Sponsor | National Children’s Research Centre |
| Funder | National Children's Research Centre |
- 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
Scientific
Paediatric Emergency Research Unit
Department of Emergency Medicine
Our Lady's Children's Hospital
Crumlin
Dublin
12
Ireland
| ronan.osullivan@olchc.ie |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre randomised double-blind non-inferiority clinical trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Dexamethasone phosphate, prednisolone |
| Primary outcome measure(s) |
Exacerbations of asthma, as measured by the Pediatric Respiratory Assessment Measure (PRAM), measured at enrolment, pre-ED discharge (4 hours) and at 4 days. |
| Key secondary outcome measure(s) |
1. Relapse rates, measured at 4 and 14 days |
| Completion date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2 Years |
| Upper age limit | 16 Years |
| Sex | All |
| Target sample size at registration | 286 |
| 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
12
Ireland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
28/05/2020: Added clinicaltrialsregister.eu link to basic results (scientific).
13/02/2020: ClinicalTrials.gov number added.
