Efficacy of budesonide inhalation suspension in infants and young children with persistent asthma. Budesonide Inhalation Suspension Study Group.

This paper reviews the results from 3 randomized, double-blind, placebo-controlled, multicenter studies that assessed the efficacy and safety of once- and twice-daily dosing of budesonide inhalation suspension (BIS) in infants and young children with persistent asthma. In children with mild persistent asthma that was previously treated with bronchodilators or noncorticosteroid anti-inflammatory agents (study A), nighttime and daytime asthma symptoms were significantly improved in 0.25-mg once daily, 0.5-mg once daily, and 1.0-mg once daily BIS treatment groups compared with placebo (P </=. 05). Rescue medications were used significantly less in all BIS groups (approximately 2 days of every 14 days) compared with placebo (P <.05). The proportion of patients who discontinued this therapy because of worsening asthma was greater in the placebo group than in the BIS groups, with the difference between placebo (23%) and the 1. 0-mg BIS group (13%) being statistically significant (P =.020). All BIS doses except 0.5 mg once daily showed nonsignificant numeric improvement in morning and evening peak expiratory flow (PEF) compared with placebo. In children with asthma that was previously treated with inhaled corticosteroids (study B), BIS doses of 0.25 mg, 0.5 mg, and 1.0 mg twice daily resulted in significant improvements in nighttime symptoms scores versus placebo (P </=.026). Rescue medications were used significantly less in all BIS groups (approximately 2.5 to 3.5 days of every 14 days) compared with placebo (P </=.032). The proportion of patients receiving placebo who discontinued therapy because of worsening asthma symptoms (36%) was significantly greater compared with the BIS groups (9%; P </=. 015). Morning PEF levels were significantly greater in each BIS group compared with placebo (P </=.03). For evening PEF levels, all BIS treatment groups showed numeric improvements compared with placebo; the 0.25-mg twice daily budesonide group showed statistically significant improvement (P <.05). In children with moderate persistent asthma that was previously maintained either on bronchodilators or inhaled corticosteroids (study C), nighttime asthma symptoms significantly improved in the 0.25-mg twice daily, 0. 5-mg twice daily, and 1.0-mg once daily BIS groups compared with placebo (P <.01); there was a numeric improvement for the 0.25-mg once daily treatment group. Rescue medications were used significantly less in all BIS groups (approximately 2 to 3 days of every 14 days) compared with placebo (P </=.014). The proportion of patients who discontinued treatment because of worsening of asthma symptoms was greater in the placebo group than in the BIS groups; the difference between 0.25-mg twice daily group (13%) and the placebo group (26%) was statistically significant (P =.029). All BIS doses showed numeric improvement in morning PEF levels, and statistically significant improvements were observed in the 0.25-mg twice daily, 0.5-mg twice daily, and 1.0-mg once daily groups compared with placebo (P <.03). Significant improvements in evening PEF levels were observed for each BIS treatment group (P </=.034), except for the 1.0-mg once daily group. Overall, the 3 studies show that once- and twice-daily dosing of BIS effectively relieves asthma symptoms and improves pulmonary function in infants and young children with mild-to-severe persistent asthma.