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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN26944158
Enrollment
286
Registered
2010-06-18
Start date
2010-07-01
Completion date
Unknown
Last updated
2020-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma Respiratory Asthma

Interventions

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

Sponsors

National Children’s Research Centre
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
1. Relapse rates, measured at 4 and 14 days 2. Treatment cost

Countries

Ireland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 25, 2026