MAP PHARMA BEGINS TRIAL OF PEDIATRIC ASTHMA DRUG

MAP Pharmaceuticals has announced the initiation of a Phase II trial evaluating MAP0010, a proprietary nebulized formulation of budesonide for the inhalation treatment of asthma in pediatric and adolescent populations. This approach is intended to provide the same efficacy as the currently marketed nebulizer product, but with a lower dose delivered in less time.

The trial will assess the efficacy of two doses of the drug and will be conducted at multiple clinical sites in the United States as a randomized, double-blind, placebo-controlled study in approximately 225 pediatric and adolescent asthma patients. The primary endpoint for the study will be asthma control as assessed by changes in daily and evening asthma symptoms compared with placebo, with secondary endpoints evaluating changes in pulmonary function. Safety evaluations will be made throughout the trial.