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Study shows use of budesonide reduced the risk of asthma related events by 40% in children

San Antonio, Tex., - March 19, 2005 New data indicated that earlier intervention with once-daily budesonide, an inhaled corticosteroid delivered by dry powder inhaler to children with mild persistent asthma, significantly reduced the long-term risk and frequency of severe asthma-related events as well as the need for other inhaled medication.

The findings, presented today at the 61st annual meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI), are from two analyses of the Inhaled Steroid as Regular Therapy in Early Asthma (START) study, a three-year trial involving nearly 2,000 children aged 5 to 10 years with mild persistent asthma. The START study was funded by AstraZeneca.

"Many children with asthma make repeated trips to the emergency room or are hospitalized because of worsening symptoms," said Dr. Albert Sheffer, Clinical Professor of Medicine at Harvard Medical School, Director Emeritus at the Allergy Clinic, Brigham and Women's Hospital in Boston and an investigator in the safety and tolerability portion of the study. "The findings of these two analyses showed that budesonide had a viable long-term treatment effect."

In the first analysis, 1,974 children were randomized to receive either once-daily budesonide or placebo in addition to usual asthma care. The earlier use of budesonide reduced the risk of exacerbation, or severe asthma related events by 40 percent compared to usual asthma care. In addition, children in the budesonide group required fewer interventions with other inhaled corticosteroids (12.3 percent versus 22.7 percent for placebo), and had improved lung function.

The second analysis tracked the adverse side effects reported by 1,981 children taking either budesonide plus usual care or placebo over three years. Overall, the incidence of side effects was comparable between the two groups, with fewer asthma exacerbations and adverse events reported in the budesonide group throughout
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Contact: Heather Law
heather.law@astrazeneca.com
302-886-1652
Burson-Marsteller
21-Mar-2005


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