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| |  AAAAI: START Trial Confirms Safety and Tolerability of Long-Term Once-Daily Budesonide in Pediatric Asthma By Bruce Sylvester SAN ANTONIO, TX -- March 21, 2005 -- Early intervention using once-daily budesonide is both safe and well tolerated in asthmatic children, with adverse event rates that are comparable to those seen with usual care, and less frequent asthma aggravations. The findings, from a pediatric subanalysis of data from the Inhaled Steroid as Regular Therapy in Early Asthma (START) study, were presented here on March 19th at the 61st annual meeting of the American Academy of Allergy, Asthma and Immunology. This 3-year trial involved patients aged 5 to 66 years; the pediatric subgroup consisted of nearly 2000 children aged 5 to 10 years who had mild persistent asthma. "The primary implication here is that this is a safe drug, it is very effective, and it is specifically so for the mild pediatric asthmatic," said presenter Albert Sheffer, MD, clinical professor of medicine, Harvard University, and director emeritus, Brigham and Women's Hospital Allergy Clinic, Boston, Massachusetts, United States. "The mild asthma pediatric patient is at risk for exacerbations, which sometimes can be fatal. We think that all young patients with mild asthma should receive at least a low dose of steroid." The analysis of START data involved 1981 children who were randomized to receive budesonide 200 mcg once daily (n = 1004) or placebo/usual care (n = 977) in addition to their usual asthma medications. Adverse events associated with infections occurred at the same rate in both groups (budesonide 43.8% and controls 43.8%) with fewer children reporting serious adverse events (106 budesonide vs. 128 placebo/usual care). The authors also reported that aggravated asthma was reported by more children receiving placebo/usual care (n = 82) than by budesonide recipients (n = 53). The most significant implication of this study is that there appears to be no difference in using budesonide versus placebo/usual care in terms of safety, which is extremely important in children, said Michael Noonan, MD, clinical director, Allergy Associates Research Center, Portland, Oregon, United States. "This supports the belief that using an inhaled steroid is safe in clinical practice with children in this age group."
[Presentation title: Safety and Tolerability of Inhaled Budesonide in Children in the START Trial. Poster 14]
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