Arch Dis Child 2000;82:126-130 ( February )

Article

Randomised placebo controlled trial of nebulised corticosteroids in acute respiratory syncytial viral bronchiolitis A Cade^a, K G Brownlee^b, S P Conway^c, D Haigh^d, A Short^e, J Brown^f, D Dassu^f, S A Mason^f, A Phillips^f, R Eglin^c, M Graham^b, A Chetcuti^a, M Chatrath^b, N Hudson^d, A Thomas^e, P A J Chetcuti^a

^a Department of Paediatrics and Child Health, Clarendon Wing, Leeds General Infirmary, Belmont Grove, Leeds LS2 9NS, UK, ^b St James's University Hospital, Leeds LS9 7TF, UK, ^c Seacroft Hospital, Leeds LS14 6UH, UK, ^d St Luke's Hospital, Bradford BD5 0NA, UK, ^e Huddersfield Royal Infirmary, Huddersfield HO3 3AE, UK, ^f Northern and Yorkshire Clinical Trials and Research Unit, Leeds LS16 6QB, UK

Correspondence to: Dr Cade

Accepted 14 October 1999

OBJECTIVETo evaluate short and long term effects of giving nebulised budesonide early in respiratory syncytial viral (RSV) bronchiolitis.
DESIGNA multicentre randomised double blind placebo controlled trial.
SUBJECTSInfants admitted to hospital with their first episode of RSV positive bronchiolitis.
INTERVENTIONRandomisation to receive either 1 mg of nebulised budesonide (Bud) or placebo (Pla) twice daily from admission until 2 weeks after discharge. Follow up was for 12 months.
MAIN OUTCOME MEASURESDuration of hospital admission, time taken to become symptom free, re-admission rates, general practitioner consultation rates, and use of antiwheeze medication during follow up.
RESULTS161 infants were studied. Both arms were similar with respect to initial clinical severity, age, sex, socioeconomic class, and tobacco exposure. Median time from first nebulisation to discharge: Bud and Pla, 2 days. Median number of days for 50% of infants to be symptom free for 48 hours: Bud, 10 days; Pla, 12 days. Respiratory re-admission rates in the 12 month follow up: Bud, 16%; Pla, 18%; median difference (95% confidence interval (CI)), 2 (14 to 10). Median respiratory related general practitioner attendances: Bud, 4.0; Pla, 4.5; median difference (95% CI), 1 (2 to 0). Percentage of infants receiving at least one prescription for antiwheeze medication during follow up, corticosteroids: Bud, 50%; Pla, 60%; difference (95% CI), 10 (26 to 6); bronchodilators: Bud, 60%; Pla, 67%; difference (95% CI), 7 (22 to 8).
CONCLUSIONSThere are no short or long term clinical benefits from the administration of nebulised corticosteroids in the acute phase of RSV bronchiolitis.


Keywords: acute viral bronchiolitis; respiratory syncytial virus; inhaled corticosteroids

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© 2000 by Archives of Disease in Childhood
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