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| |  AAAAI: Once-Daily Budesonide Does Not Suppress Growth Velocity in Children With Perennial Allergic Rhinitis By Bonnie Darves SAN FRANCISCO, CA -- March 23, 2004 -- Results of a clinical study show that once-daily budesonide aqueous nasal spray does not significantly suppress growth velocity in young children. Results of the multicentre, double blind, placebo controlled study were presented here March 21st at the American Academy of Allergy, Asthma & Immunology Annual Meeting. "In children, long-term continual use of corticosteroids has raised concerns about [decreased] growth, and studies of children treated with oral budesonide suggest a dose-related reduction in growth velocity during the first year of treatment," said the study's lead author Kevin Murphy, MD, Midwest Allergy & Asthma Clinic, Omaha, Nebraska, United States. He added that most studies have found no long-term effects on growth, but that parents' concerns have possibly prevented some children, including those with concomitant allergic rhinitis and asthma, from receiving appropriate treatment. In the 21-month study of 229 patients between the ages of 4 and 8 years (mean age 5.9 years and predominantly male) with perennial allergic rhinitis, researchers looked at the effect of a once-daily 64 mcg dose of budesonide on growth velocity and height percentile. An initial 6-month phase to assess growth velocity preceded the 12-month double-blind treatment period, in which the children were randomised in a 2:1 ratio to receive either budesonide or placebo. A 3-month follow-up assessment period concluded the study. For inclusion, patients had to be diagnosed as having Tanner Stage 1 disease and a longer than 1-year history of perennial allergic rhinitis. The children also had to be able to demonstrate effective use of the medication. In all, 71% of patients on budesonide completed the study, compared to 77% patients in the placebo group. On study completion, the researchers found that mean growth velocity was comparable for the budesonide and placebo group -- 5.91 for the budesonide group and 6.19 for those on placebo. Nor did budesonide treatment significantly affect height percentile compared with placebo. Over the year of treatment, the percentage of patients whose height percentile decreased was 58.5% in the budesonide group and 54.1% in the placebo group. "We didn't see any statistically significant difference between the 2 groups, for either of these secondary growth assessments," Dr. Murphy said, noting that urinary corticosteroid creatinine levels were also comparable. He added that, as might be expected, patients on placebo experienced more serious adverse events than the treatment group (5 versus 0), but there was no difference between the 2 groups in common non-serious adverse effects such as fever, cough, upper airway infection and sinusitis. In response to questions about efficacy and treatment compliance, Dr. Murphy noted that the study design was not inclusive of efficacy and that researchers believed compliance rates were high based on the return of treatment containers. The study was supported by AstraZeneca.
[Study title: Recommended Once-Daily Dose Of Budesonide Aqueous Nasal Spray (Rhinocort Aqua®) Does Not Suppress Growth Velocity In Pediatric Patients With Perennial Allergic Rhinitis. Poster 600]
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