Objective: To evaluate the efficacy of aerosolized budesonide therapy (with
metered dose inhaler and spacer) early in the emergency room treatment of
acute moderate exacerbations of bronchial asthma in children.
Design: Randomized, double-blind, placebo-controlled trial.
Setting: Paediatric Emergency Service of an urban teaching hospital and a t
ertiary case referral centre.
Study population: Sixty children between 3 and 12 years of age with an acut
e moderate exacerbation of asthma.
Intervention: All patients received humidified oxygen (5-8 L/min by Venturi
(R) mask; Hudson Respiratory Care, Temecula, CA, USA), nebulized salbutamol
(0.15 mg/kg in 3 mt saline) and were randomized to receive either budesoni
de (400 mu g) or placebo inhalation (MDI and spacer) at half hourly interva
ls for three doses, if there was an inadequate response or no response to t
reatment at the end of 2 h, oxygen and salbutamol therapy were continued an
d the patient was given one of dose intravenous hydrocortisone and was star
ted on an aminophylline infusion. if there was no response at the end of a
further 4 h, the patient was hospitalized.
Initial evaluation and monitoring: Colour, respiratory rate (RR), heart rat
e, accessory muscle usage, chest retraction, wheeze, oxygen saturation (by
pulse oximetery) and peak expiratory flow rate (PEFR) was recorded at admis
sion and thereafter at hourly intervals for 3 h or until till the child rec
overed. The need for oxygen therapy after 2 h and need for hospitalization
were recorded.
Main results: Both groups showed a significant improvement in respiratory s
tatus at the end of 2 h. However, children in the intervention group showed
greater improvements in RR and PEFR (P < 0.05) and respiratory distress sc
ore (P < 0.1). A significantly lower proportion of the intervention group p
atients required oxygen therapy for more than 2 h (23% vs 50%; P < 0.05) an
d aminophylline infusion and systemic corticosteroid therapy (7% vs 27%; P
< 0.05). None of the children in the budesonide group, in contrast to 23% o
f those in the placebo group, required hospitalization (P < 0.05). The leng
th of hospital stay (i.e. time taken to recover from acute asthma) was sign
ificantly shorter in the intervention group (3.2 +/- 2.5 h) than in the pla
cebo group (7.8 +/- 11.3 h; P < 0.01).
Conclusion: Aerosolized budesonide therapy (with MDI and spacer) together w
ith nebulized salbutamol early in the emergency room treatment of acute mod
erate exacerbations of asthma helped in early recovery and decreased the ne
ed for hospitalization. It may be worthwhile calculating this regimen for h
ome-based early treatment of acute exacerbations.