Jyw. Wong et al., No objective benefit from steroids inhaled via a spacer in infants recovering from bronchiolitis, EUR RESP J, 15(2), 2000, pp. 388-394
A double-blind randomized placebo-controlled trial was conducted to investi
gate the efficacy of 3 months' inhaled steroids delivered via a spacer devi
ce with face mask attachment to infants recovering from bronchiolitis,
Forty-eight previously healthy infants recovering from their first document
ed episode of acute bronchiolitis were randomized to receive 150 mu g fluti
casone propionate (FP) b.i.d. or placebo delivered via the Babyhaler spacer
. Longitudinal assessments were performed on seven occasions over 1 yr base
d on symptom diaries and health records, clinical examinations, overnight c
ough recordings and oxygen saturation readings. Lung function was measured
6 months after hospital discharge, Forty-three infants completed the trial
(FP 21, placebo 22),
There were no significant differences in the three objective end-points mea
sured, recorded night cough, oxygen saturation and lung function test resul
ts. Symptom scores were low in both the FP and placebo groups with the abse
nce of (0) or mild (1) symptoms greater than or equal to 90% of the trial d
ays. No statistical differences in symptom frequency, use of rescue respira
tory medications or hospital admissions between treatment groups were found
throughout the trial or follow-up periods.
In conclusion, the use of inhaled fluticasone propionate in infants recover
ing from acute bronchiolitis cannot be recommended.