The efficacy and safety of budesonide inhalation suspension: a nebulizable corticosteroid for persistent asthma in infants and young children.

OBJECTIVE: This study evaluated the efficacy and safety of four dosing regimens of budesonide inhalation suspension in children ages 6 months to 8 years with moderate persistent asthma.

METHODS: This 12-week, randomized, double-blind, placebo-controlled, parallel-group study involved 481 children at 38 centers throughout the United States. Active treatment groups were budesonide inhalation suspension .25 mg once daily (QD), .25-mg two times daily (BID), .5-mg BID, or 1-mg QD. Efficacy was assessed by recording nighttime and daytime asthma symptoms, use of rescue medication, and discontinuation from the study because of worsening asthma and/or a requirement for systemic steroids. Objective measures of pulmonary function were assessed in children who were capable of consistently performing pulmonary function tests; peak expiratory flow (PEF) measurements were recorded twice daily on diary cards, and spirometry was recorded at clinic visits.

RESULTS: Baseline patient demographics, nighttime and daytime symptom scores, and pulmonary function data were similar across placebo and budesonide treatment groups. The majority of patients were male (64%) with a mean age of 55.0 +/- 26.3 months. The mean duration of asthma was 34.2 +/- 22.9 months, and mean baseline forced expiratory volume in 1 second (FEV1) was 79.8% of predicted, with 29.1% reversibility. Significant improvements in nighttime and daytime asthma symptoms scores were observed in budesonide treatment groups, compared with placebo. The mean change from baseline to week 0-12 for nighttime and daytime asthma symptom scores was significantly greater for the .25-mg BID, .5-mg BID, and 1-mg QD budesonide treatment groups, compared with placebo; significant clinical improvement was observed by the second week of treatment. The lowest budesonide dose used (.25 mg QD) resulted in numerical improvements in symptom scores that were not statistically significant when compared to placebo. Significant improvements in morning PEF were observed in all budesonide treatment groups, except for the .25-mg QD group, compared with placebo. All treatment groups showed numerical improvement in FEV1, but only the .5-mg BID dose was significantly different from placebo.

CONCLUSIONS: The results of this study demonstrate that budesonide inhalation suspension is effective and well tolerated for infants and young children with moderate persistent asthma. Budesonide inhalation suspension is an important therapeutic option for young children who are not able to use other available delivery devices.