To examine the safety of budesonide inhalation suspension (BIS) in infants.

A 12-week, double-blind, placebo-controlled, parallel-group study was conducted in infants aged 6-12 months with mild to moderate asthma or recurrent wheeze who were randomized to once-daily BIS 0.5 or 1.0 mg, or placebo. Safety was assessed by adverse events (AEs), changes from baseline in vital signs, physical examinations, oropharyngeal and nasal fungal cultures, and laboratory results. Analysis included all patients who received ≥1 dose and had ≥1 observation (n=141).

The majority of AEs were mild to moderate; 43 (97.7%), 43 (89.6%), and 43 (87.8%) patients receiving BIS 1 mg, 0.5 mg, and placebo had ≥1 AE, respectively. Five patients receiving BIS experienced serious AEs (2 aggravated asthma, 1 pneumonia, 1 respiratory and 1 viral infection) that were considered unrelated to treatment; 2 of these patients discontinued early. One patient receiving BIS 0.5 mg also discontinued prematurely because of a facial/neck rash. No serious AEs were reported for placebo. Changes in vital signs and laboratory results were comparable among groups. Although difficult to assess over a 12-week period, body length increased in all groups, with mean values of 3.1, 3.5, and 3.7 cm in the infants receiving BIS 1.0 mg, BIS 0.5 mg, and placebo, respectively (P>0.5). No significant differences between groups in baseline-adjusted oropharyngeal or nasal fungal cultures occurred.

Consistent with long-term safety of BIS in older pediatric patients, once-daily BIS in infants aged 6 to 12 months was well tolerated and comparable with placebo.