Safety of budesonide inhalation suspension in infants aged six to twelve months with mild to moderate persistent asthma or recurrent wheeze

Objective To compare the safety of budesonide inhalation suspension (BIS) with placebo in infants 6 to 12 months of age with mild to moderate persistent asthma or recurrent wheeze. Study design in this multicenter, randomized, donble-blinded, parallel-group, placebo-controlled study, 141 patients received 0.5 mg BIS (n = 48), 1.0 mg BIS (n = 44), or placebo (n 49) once daily for 12 weeks. The primary variable wits adrenal function based on cosyntropin-stimulated plasma cortisol levels. Spontaneous adverse, events and clinical laboratory findings also were monitored. Results Overall, the types and frequencies of adverse events reported during the study were comparable across treatment groups. The response to cosyntropin stimulation wits similar across treatment groups, with no significant difference between BIS treatment and placebo. Conclusions The safety profile of BIS was similar to that of placebo, with no suppressive effect on adrenal function in patients 6 to 12 months of age with mild to moderate persistent asthma or recurrent wheeze.