Wilmington, DE May 20, 2008 A new 12-week study2examined safety and efficacy measures of the maintenance combination asthma therapy, SYMBICORT (budesonide/formoterol fumarate dehydrate) Inhalation Aerosol,2 in treating mild to moderate persistent asthma in children ages 6 to 15 years old2 who were previously treated with an inhaled corticosteroid (ICS).2 Of note, the study included efficacy assessments of nighttime symptoms, nighttime rescue medication use and rescue medication-free days in patients taking SYMBICORT compared to those taking formoterol dry powder inhaler (DPI) or budesonide pressurized metered-dose inhaler (pMDI). Results were presented today at the International Conference of the American Thoracic Society held in Toronto, Canada, May 16-21, 2008.
Children with asthma, who are not adequately controlled by ICS therapy, may have their sleep affected by asthma symptoms,6 said Kathy Lampl, MD, Director, Clinical Research, AstraZeneca. Combination therapy with inhaled ICS and LABA is one of the recommended regimens for children who have moderate to severe persistent asthma or are not controlled with ICS therapy alone, according to the NIH Guidelines. 7
AstraZeneca (NYSE:AZN) anticipates filing a supplemental new drug application with the Food and Drug Administration for the pediatric indication of SYMBICORT in the first half of 2008.
About the Study (Abstracts #K66 and K67)
The safety profile and efficacy measures of SYMBICORT were assessed during a 12-week randomized, double-blind, active-controlled study that evaluated 411 children ages 6 to 15 years old with mild to moderate persistent asthma1,2 previously treated with ICS therapy.1,2 After a two-week period during which patients discontinued their current asthma medications and received two inhalations twice-daily of budesonide pMDI 40 micrograms (mcg), 128 patients1,2 were randomized to receive treatment with SYMBICORT pMDI 40/4.5 mcg two inhalations
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