Randomised placebo controlled trial of nebulised corticosteroids in acute respiratory syncytial viral bronchiolitis.
OBJECTIVE
To evaluate short and long term effects of giving nebulised budesonide early in respiratory syncytial viral (RSV) bronchiolitis.


METHODS
A multicentre randomised double blind placebo controlled trial.


METHODS
Infants admitted to hospital with their first episode of RSV positive bronchiolitis.


METHODS
Randomisation 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.


METHODS
Duration of hospital admission, time taken to become symptom free, re-admission rates, general practitioner consultation rates, and use of anti-wheeze medication during follow up.


RESULTS
161 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 anti-wheeze 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).


CONCLUSIONS
There are no short or long term clinical benefits from the administration of nebulised corticosteroids in the acute phase of RSV bronchiolitis.
Cade
A
A
Department of Paediatrics and Child Health, Clarendon Wing, Leeds General Infirmary, Belmont Grove, Leeds LS2 9NS, UK.
Brownlee
K G
KG
Conway
S P
SP
Haigh
D
D
Short
A
A
Brown
J
J
Dassu
D
D
Mason
S A
SA
Phillips
A
A
Eglin
R
R
Graham
M
M
Chetcuti
A
A
Chatrath
M
M
Hudson
N
N
Thomas
A
A
Chetcuti
P A
PA
D000208:Acute Disease; D000287:Administration, Topical; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D001990:Bronchiolitis, Viral / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000627:therapeutic use*; D019819:Budesonide / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids; D006760:Hospitalization; D006801:Humans; D007223:Infant; D008297:Male; D009330:Nebulizers and Vaporizers; D018357:Respiratory Syncytial Virus Infections / Q000188:drug therapy*
D000893:Anti-Inflammatory Agents; D001993:Bronchodilator Agents; D005938:Glucocorticoids; D019819:Budesonide