A 5- versus 3-day course of oral corticosteroids for children with asthma exacerbations who are not hospitalised : a randomised controlled trial

Chang, Anne B., Clark, Ronald, Sloots, Theo P., Stone, David G., Petsky, Helen L., Thearle, Donna, Champion, Anita A., Wheeler, Coralie, & Acworth, Jason P. (2008) A 5- versus 3-day course of oral corticosteroids for children with asthma exacerbations who are not hospitalised : a randomised controlled trial. Medical Journal of Australia, 189(6), pp. 306-310.

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Abstract

Objective

To determine whether a 5-day course of oral prednisolone is superior to a 3-day course in reducing the 2-week morbidity of children with asthma exacerbations who are not hospitalised.

Design, setting and participants

Double-blind randomised controlled trial of asthma outcomes following a 5-day course of oral prednisolone (1 mg/kg) compared with a 3-day course of prednisolone plus placebo for 2 days. Participants were children aged 2–15 years who presented to the emergency departments of three Queensland hospitals between March 2004 and February 2007 with an acute exacerbation of asthma, but were not hospitalised. Sample size was defined a priori for a study power of 90%.

Main outcome measures

Difference in proportion of children who were symptom-free at Day 7, as measured by intention-to-treat (ITT) and per-protocol analysis; quality of life (QOL) on Days 7 and 14.

Results

201 children were enrolled, and there was an 82% completion rate. There was no difference between groups in the proportion of children who were symptom-free (observed difference, 0.04 [95% CI, − 0.09 to 0.18] by ITT analysis; 0.04 [95% CI, − 0.17 to 0.09] by per-protocol analysis). There was also no difference between groups in QOL (P = 0.42). The difference between groups for the primary outcome was within the equivalence range calculated post priori.

Conclusion

A 5-day course of oral prednisolone confers no advantage over a 3-day course for children with asthma exacerbations who are not hospitalised.

Impact and interest:

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ID Code: 71260
Item Type: Journal Article
Refereed: Yes
Keywords: asthma, oral corticosteroids, asthma exacerbations
ISSN: 0025-729X
Subjects: Australian and New Zealand Standard Research Classification > MEDICAL AND HEALTH SCIENCES (110000) > CARDIOVASCULAR MEDICINE AND HAEMATOLOGY (110200) > Respiratory Diseases (110203)
Australian and New Zealand Standard Research Classification > MEDICAL AND HEALTH SCIENCES (110000) > PAEDIATRICS AND REPRODUCTIVE MEDICINE (111400) > Paediatrics (111403)
Divisions: Current > QUT Faculties and Divisions > Faculty of Health
Current > Institutes > Institute of Health and Biomedical Innovation
Current > Schools > School of Public Health & Social Work
Deposited On: 28 Aug 2014 23:42
Last Modified: 29 Jan 2015 00:26

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