2008 Volume 22 Issue 1 Pages 116-128
An open long-term extension study was conducted to investigate long-term safety of the budesonide inhalation suspension in infants with bronchial asthma, following an open, randomized, parallel-group study to investigate efficacy and safety of 24-week treatment of the drug. Of the 57 patients who completed the open, randomized, parallel-group study, 54 patients entered this study and all were evaluated for safety. The treatment period was 34 to 144 weeks (mean 102 weeks). The adverse event profile observed in this study was comparable to that in the open, randomized, parallel-group study, i.e., there were no new clinically relevant adverse events and frequency of adverse events did not increase along with the treatment extension. The mean plasma cortisol values were below the baseline of the open, randomized, parallel-group study throughout the treatment period, however, no further decrease was observed and there were no signs or symptoms suggesting adrenal suppression. No effects on growth were observed. Efficacy rate determined by the investigator was 80% or higher through the period of the study. The long-term treatment with budesonide inhalation suspension (maximum 168 weeks including the open, randomized, parallel-group study) in infants with bronchial asthma is suggested to be safe and effective.
