Purpose of the Study. To compare the safety of budesonide inhalation suspension (BIS) with placebo.
Study Population. Infants (aged 6–12 months) with mild-to-moderate persistent asthma or recurrent wheeze.
Methods. A multicenter, randomized, double-blinded, parallel-group, placebo-controlled study, in which 141 infants received 0.5 mg of BIS (n = 48), 1.0 mg of BIS (n = 44), or placebo (n = 49) once daily for 12 weeks. The primary variable was adrenal function, which was based on cosyntropin-stimulated plasma cortisol levels. Spontaneous adverse events and clinical laboratory findings 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 was 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.
Reviewer Comments. Inhaled corticosteroids remain the preferred choice for the long-term management of persistent asthma in pediatric patients. In addition, because BIS has become available for clinical use, more and more infants and young children with persistent asthma and/or recurrent episodes of wheezing have been managed with this inhaled antiinflammatory medication. In turn, appropriate questions have arisen from caregivers and providers about the overall safety of this therapy in these very young patients. Although the safety and efficacy of nebulized BIS have been confirmed in well-designed investigations in patients 6 months to 8 years of age, controlled clinical studies addressing the safety and efficacy of inhaled corticosteroids exclusively in the infant age range have been lacking. This current investigation provides very useful safety data for BIS in this understudied infant population. The data demonstrate that once-daily administration of BIS, 0.5 or 1.0 mg, was not associated with a decrease in adrenal function, which was based on cosyntropin-stimulated plasma cortisol levels. This information should be very useful to health care providers who prescribe this medication for young infants with mild-to-moderate persistent asthma or recurrent wheeze.
- Copyright © 2006 by the American Academy of Pediatrics