You are here

Poor Asthma Control Demonstrated in Phase 3 Trial of Unit Dose Budesonide

MOUNTAIN VIEW, Calif., Feb 23, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) announced today results of its initial Phase 3 clinical trial of Unit Dose Budesonide (UDB) for the potential treatment of children with asthma. The Company announced that the clinical trial did not meet its co-primary endpoints, asthma control as assessed by changes from baseline in nighttime and daytime composite symptom scores, in either of the doses evaluated, when compared with placebo. Median nebulization times were less than four minutes for both doses in the study. Initial review of the data has not identified any serious adverse events attributed to study drug. Patients continue to be treated in a 52-week safety study to collect long-term safety data on the two doses under investigation.

"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

Recent Headlines

Despite older, sicker patients, mortality rate fell by a third in 10 years
Study finds fewer than half of trials followed the law
WHO to meet tomorrow to decide on international public heath emergency declaration
Study of posted prices finds wild variations and missing data
Potential contamination could lead to supply chain disruptions
Kinase inhibitor targets tumors with a PDGFRA exon 18 mutation
Delayed surgery reduces benefits; premature surgery raises risks
Mortality nearly doubled when patients stopped using their drugs
Acasti reports disappointing results for a second Omega-3-based drug