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Poor Asthma Control Demonstrated in Phase 3 Trial of Unit Dose Budesonide
"Based on our initial review of these data, both the placebo and study groups experienced improvements in asthma symptoms, but the differences were not statistically significant. We observed a higher than expected response in the placebo group, starting as early as one week after randomization and continuing throughout the 12 week treatment period," said Timothy S. Nelson, Chief Executive Officer of MAP Pharmaceuticals. "We and our partner, AstraZeneca, are conducting further analyses of these data to determine appropriate next steps going forward for the program. The Company remains dedicated to developing therapies for children suffering from asthma."
About the Study
In this randomized, double-blind, placebo-controlled study, 360 steroid naïve children with asthma, 12-months to eight years of age, were randomized to receive 0.25mg UDB, 0.135mg UDB or placebo twice a day over a 12-week period. The co-primary endpoints evaluated asthma control as assessed by changes from baseline as compared to placebo in nighttime composite symptom scores, and daytime composite symptom scores, both comprised of cough, wheeze and shortness of breath.
Source: MAP Pharmaceuticals