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| |  Asthma Maintenance Therapy With Budesonide/Formoterol Safe for Younger Children: Presented at AAAAI By Em Brown, BSN PHILADELPHIA -- March 24, 2008 -- Inhaled corticosteroids (ICS) are only approved for use as maintenance therapy in asthma patients aged 12 years and older, however a study presented here on March 17 at the American Academy and Allergy, Asthma & Immunology (AAAAI) Annual Meeting showed that ICS is safe for children as young as 6 years. Jeffrey G. Leflein, MD, Allergist, Allergy and Immunology Associates of Ann Arbor, Ypsilanti, Michigan, led a 26-week multicenter trial of budesonide plus formoterol delivered together via metered-dose inhaler in 189 children between the ages of 6 and 11 years with mild to severe asthma who had been receiving inhaled corticosteroids. After 1 week of observation, with the children using their usual ICS, Dr. Leflein's team randomized the children to twice-daily treatment with 2 inhalations of budesonide 160 mcg plus formoterol 4.5 mcg (123 children) or to 2 inhalations of budesonide 160 mcg twice a day (63 children). The investigators assessed treatment effect on height and 24-hour urinary cortisol levels after 26 weeks of treatment as well as the rate of adverse events. Drug-related adverse events occurred in 4.9% of children on budesonide/formoterol and 6.3% of children on budesonide. There were no significant differences in changes in height after 26 weeks between monotherapy and combination therapy with the ICS, with a growth of 2.51 cm with budesonide/formoterol and 2.10 cm with budesonide monotherapy. Decreases in 24-hour urinary cortisol levels were numerically smaller with budesonide/formoterol versus budesonide alone, but the difference was not statistically significant, Dr. Leflein reported. Combination therapy resulted in significantly better pulmonary function and reduced resource utilization compared with budesonide monotherapy. In addition, 6 months of combination therapy resulted in significant improvements in patients' scores for self-reported quality of life and caregiver quality of life, and in a significantly greater percentage of caregivers reporting improvements in their child's asthma control. The rate of hospitalization was low in both groups. "In the rest of the world, budesonide/formoterol is approved for use in children as young as 6 [years]," Dr. Leflein said. "Budesonide/formoterol is a very nice medication. It is extremely safe. We've seen it used safely for years in babies as young as 6 months of age." AstraZeneca is looking to bring a New Drug Application to the US Food and Drug Administration in the next few months for approval of the combination product for use in children between 6 and 11 years of age, Dr. Leflein said. Funding for this study was provided by AstraZeneca.
[Presentation title: Long-Term Safety and Systemic Effects of Budesonide and Formoterol Administered Via One Pressurized Metered-Dose Inhaler (pMDI) in Children With Asthma. Poster 597]
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