The purpose of the Phase III trial is to evaluate the safety and efficacy of unit dose budesonide (UDB) in approximately 360 children from 12 months to eight years of age.
The multi-center, randomized, double-blind, placebo controlled study has enrolled children 12 months to eight years of age. Patients complete a two week screening period and those who meet the entry criteria are then randomized to a 12-week treatment period receiving twice daily 0.25mg UDB, 0.135mg UDB or placebo.
The primary efficacy endpoints for the study are the changes in nighttime and daytime composite symptom scores, which are comprised of cough, wheeze and breathlessness. According to the company, UDB is designed to be administered more quickly and to provide efficacy at a lower dose than the commercially available product.
Timothy Nelson, president and CEO of Map Pharmaceuticals, said: “Completion of enrollment of this study represents an important milestone in the development of UDB. We would like to thank our clinical investigators as well as parents for their strong interest in and support for studying the potential benefits of UDB therapy. We believe UDB has the potential to offer both physicians and families with asthmatic children a convenient, low-dose therapy to treat this chronic condition.”