The study examined the safety of Symbicort in children for 26 weeks and also included efficacy measures. For children previously treated with inhaled corticosteroid, either alone or in combination, the study showed that long-term treatment with Symbicort resulted in significantly greater improvements in lung function and reduced healthcare resource utilization, compared with budesonide dry powder inhaler (DPI) alone. In the study, Symbicort also had a safety profile similar to its monocomponent, budesonide, which is an approved asthma medication for children.
Results showed that mean changes in predose forced expiratory volume in one second (FEV1) were significantly greater for Symbicort versus budesonide. In addition, the percentage of patients receiving Symbicort (3.3%) who had at least one urgent care visit was significantly lower compared with patients using budesonide (11.1%) (p<0.05). Results also found that Symbicort was well tolerated over 26 weeks with a similar safety profile to budesonide. AstraZeneca anticipates filing a supplemental new drug application with the FDA for the pediatric indication of Symbicort in the first half of 2008.