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| |  Bronchodilation With Budesonide and Formoterol Combination Equivalent to Formoterol Alone, Better than Budesonide Alone: Presented at AAAAI By Paula Moyer SAN DIEGO, CA -- February 27, 2007 -- A new pressurised metered dose inhaler (pMDI) that combines the inhaled corticosteroid budesonide and the long-acting beta-agonist formoterol (Symbicort) induces bronchodilation as rapidly as does formoterol (Foradil) alone and more rapidly than either budesonide (Pulmicort) alone or placebo, according to data from 2 studies. "We found that the combination [budesonide/formoterol] caused as rapid bronchodilation as we have seen with fast-acting beta-agonists," said principal investigator Harold B. Kaiser, MD, clinical professor of medicine, University of Minnesota Medical School, Minneapolis, Minnesota, United States. "This expands our treatment options in the area of combination therapies." Dr. Kaiser presented the findings of two 12-week, randomised, double-blind, placebo-controlled, multicentre studies in a poster session here on February 27th at the American Academy of Allergy, Asthma, and Immunology (AAAAI) annual meeting. He and his co-investigators wanted to evaluate the onset of bronchodilation in patients with asthma who received the combination treatment and who had previously received inhaled corticosteroids. In the first study, patients who had moderate to severe asthma first underwent a 2-week run-in period in which they received 2 inhalations twice daily of budesonide through a pressurized metered dose inhaler at a dose of 80 mcg. Patients were then randomly assigned to 1 of the following treatments: In the second study, patients with mild to moderate asthma underwent a 2-week run-in period in which their asthma therapy was discontinued. They were then randomised to receive 1 of the following treatments: · 2 inhalations twice daily of the combination budesonide 80 mcg and formoterol 4.5 mcg by pressurized metered dose inhaler (123 patients); After treatment, the investigators assessed the length of time before patients achieved at least a 15% improvement in their forced expiratory volume at 1 second (15% FEV1). In both studies after the first dose of treatment on the day of randomisation, the time to 15% FEV1 was significantly earlier with the combination in a pressurized metered dose inhaler than either agent alone or placebo (P < . 001). The percentages of patients achieving this level of improvement within 15 minutes after treatment on the day of randomisation consisted of: · Budesonide/formoterol pressurized metered dose inhaler: 56.5% in the first study and 48.8% in the second study; Symbicort has been approved for the long-term maintenance treatment of asthma in patients 12 and older who are appropriate for combination therapy, and is expected to be available in the U.S. in mid-2007, according to Chris O'Brien, MD, senior director, medical science division, AstraZeneca, which manufactures Symbicort and funded the study.
[Presentation title: Measured Onset of Bronchodilation With Budesonide and Formoterol Administered Via One Pressurised Metered-dose Inhaler (pMDI) in Patients With Asthma Previously Receiving Inhaled Corticosteroids. Abstract 972]
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