Effects of nebulized high-dose budesonide on moderate-to-severe acute exacerbation of asthma in children: A randomized, double-blind, placebo-controlled study

Background and objectiveThe efficacy of inhaled corticosteroids (ICS) in asthma exacerbation are yet to be clarified. The aim of this study was to investigate the efficacy of nebulized ICS in children with moderate-to-severe acute exacerbation of asthma in an emergency room setting in order to elucidate the potential use of ICS as the first-line therapy in the management of acute exacerbation of asthma. MethodsThis was a prospective, randomized, double-blind, placebo-controlled study. Paediatric patients with moderate-to-severe acute exacerbation of asthma in emergency room were randomized to receive nebulized salbutamol and ipratropium bromide, with the addition of nebulized high-dose budesonide (BUD group, n=60) or normal saline (control group, n=58), three doses in the first hour. ResultsThe improvement in forced expiratory volume in 1s was similar in both groups at 0h after three doses of nebulization, but there was significantly further improvement at 1 and 2h in the BUD group (0.0950.062L and 0.1000.120L, respectively) compared with the control group (0.059 +/- 0.082L and 0.021 +/- 0.128L, respectively), P=0.013 and 0.001, respectively. Complete remission rate was significantly higher (84.7% vs 46.3%, P=0.004) and need for oral corticosteroids was significantly lower (16.9% vs 46.3%, P=0.011) in BUD group than in control group. ConclusionOn the basis of nebulized short-acting bronchodilators, addition of nebulized high-dose budesonide resulted in clinical improvement in children with moderate-to-severe acute exacerbation of asthma, suggesting that nebulized high-dose ICS can be used as first-line therapy for non-life-threatening acute exacerbation of asthma in children. This prospective, randomized, double-blind, placebo-controlled study showed that on the basis of nebulized salbutamol and ipratropium bromide, nebulized high-dose budesonide as the first-line therapy for paediatric patients with moderate-to-severe acute exacerbation of asthma is effective in improving symptoms and reducing the need of systemic corticosteroid and hospitalization.