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 OBJECTIVE: The 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. METHODS: This 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. RESULTS: The improvement in forced expiratory volume in 1 s was similar in both groups at 0 h after three doses of nebulization, but there was significantly further improvement at 1 and 2 h in the BUD group (0.095 ± 0.062 L and 0.100 ± 0.120 L, respectively) compared with the control group (0.059 ± 0.082 L and 0.021 ± 0.128 L, 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. CONCLUSION: On 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.

[The efficacy of nebulized budesonide in acute moderate to severe exacerbations of asthma in children].

OBJECTIVE: To evaluate the effect of nebulized budesonide (BUD) in acute moderate to severe exacerbations of asthma in children. METHODS: Forty children, 5 to 15 years of age, with acute moderate to severe attacks of asthma, were randomized into BUD group and control group, receiving nebulized 0.5% salbutamol (150 µg/kg) + 0.025% ipratropium bromide (1 ml) + 0.05% budesonide (2 ml) or nebulized 0.5% salbutamol (150 µg/kg) + 0.025% ipratropium bromide (1 ml) + saline (2 ml) at half-hourly intervals for 3 doses respectively. Lung function, respiratory rate (RR), heart rate(HR), oxygen saturation (SaO2) and clinical score (CS) were monitored. RESULTS: The baseline characteristics of the 2 groups were similar. After 3 doses of nebulization, CS, RR, SaO2, FEV(1) and FEV(1)% were significantly improved in both groups (P < 0.05). The CS in BUD group was significantly lower than that in control group at the end of 2 h after the third dose of nebulization 0 (0) vs 0 (1), Z = 2.522, P = 0.012. There were no significant differences in RR, HR and SaO2 between 2 groups (P > 0.05). The improvement of FEV(1)% in the first hour and the second hour after 3 doses of nebulization was 8.0 (6.8)% and 5.5 (6.5)% in BUD group, and 6.0 (8.5)% and 1.0 (6.5)% in control group, the improvement in BUD group being significantly greater than that in control group (Z = 2.270 and 2.686, P = 0.023 and 0.007 respectively). The improvement of FEV(1) in the second hour after 3 doses of nebulization was significantly greater in BUD group than in control group 0.07 (0.12) L vs 0.01 (0.10) L, Z = 2.455, P = 0.014. The full recovery rate in BUD group at the end of 2 h after completion of nebulization was significantly higher than that in control group (17/20, 85.0% vs 9/18, 50.0%, χ(2) = 5.371, P = 0.024). The proportion of patients who needed to use oral corticosteroids was significantly lower in BUD group than in control group (3/20, 15.0% vs 8/18, 44.4%, χ(2) = 3.993, P = 0.046). The hospitalization rate was 5% (1/20) in BUD group, and 17% (3/18) in control group, but the difference was not statistically significant (P > 0.05). CONCLUSION: Nebulized BUD in high dose and at short intervals combined with rapid-acting bronchodilators has an additional bronchodilator response, associated with more rapid and better improvement in clinical symptoms and lung function, indicating that it is preferred in the early management of acute moderate to severe exacerbation of asthma in children.