Budesonide inhalation suspension (BIS) is a safe asthma treatment for infants, according to a new study.

Although previous trials have shown that BIS can be safely used to treat children, only a few infants less than a year old were included in these studies. As such, the US Food and Drug Administration requested additional data showing that budesonide inhalation is safe for this group.

The current study, reported in the Journal of Pediatrics, involved 141 infants 6 to 12 months of age with mild-to-moderate persistent asthma or recurrent wheeze. The infants were randomly assigned to treatment with one of two doses of BIS or and inactive placebo once daily for 12 weeks.

Overall, no significant differences were seen between the groups in the type or frequency of adverse events, lead author Dr. William E. Berger, from Allergy and Asthma Associates of Southern California in Mission Viejo, and colleagues note.

The results indicate that BIS is a safe and well-tolerated treatment for asthma and wheeze in infants, the investigators conclude.

The study was supported by AstraZeneca LP, which markets BIS as Pulmicort Respules.

SOURCE: Journal of Pediatrics, January 2005.