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Medicineworld.org: Symbicortand Improves Lung Function

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Symbicortand Improves Lung Function

Symbicortand Improves Lung Function
Wilmington, DE February 24, 2007 New data demonstrated the maintenance combination asthma treatment, SYMBICORT (budesonide/formoterol fumarate dehydrate), provides a rapid, clinically significant bronchodilatory response, or opening of the airways, defined as the median time to achieve ≥15% improvement in lung function within 15 minutes after administration. In addition, these data demonstrated that compared to its monocomponents (budesonide and formoterol) and placebo, SYMBICORT and the other therapy groups containing formoterol had a faster bronchodilatory response than budesonide or placebo. The combined study results, involving patients with mild-to-severe persistent asthma who previously mandatory therapy with inhaled corticosteroids (ICS), were presented today at the annual meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI) held in San Diego, February 23-27, 2007.

SYMBICORT is a newly approved, twice-daily, inhaled combination treatment containing budesonide, a corticosteroid, and formoterol, a rapid and long-acting beta2-agonist. It is indicated for the long-term maintenance therapy of asthma in patients ages 12 and older. SYMBICORT is not indicated in patients whose asthma can be successfully managed by inhaled corticosteroids along with occasional use of inhaled, short-acting beta2-agonists.

Additional data from these studies presented at AAAAI showed SYMBICORT provided significantly greater improvements in asthma control in comparison to its monocomponents (budesonide or formoterol) or placebo in patients with mild-to-moderate asthma who mandatory an ICS. In patients with moderate-to-severe asthma who mandatory an ICS, SYMBICORT also demonstrated significantly greater improvement in lung function in comparison to its monocomponents (budesonide or formoterol) or placebo.

"With an estimated 20 million patients currently suffering from asthma in the U.S., SYMBICORT represents an exciting new therapy option and a welcome addition to our respiratory franchise," said Chris O'Brien, Senior Director, Medical Science, AstraZeneca. "We are dedicated to the development of new, effective therapys to improve lung health and are looking forward to making SYMBICORT available in the U.S".


Study Results

Abstract #974: Bronchodilatory response rate was investigated in two 12-week, randomized double-blind, placebo-controlled, multicenter studies. Study I involved 596 patients with moderate-to-severe asthma who were randomized after a two-week run-in (two inhalations bid budesonide pMDI 80 mg), into one of five groups, including: therapy with two inhalations twice daily with SYMBICORT (budesonide/formoterol pMDI) 160/4.5 micrograms (mg), budesonide pMDI 160 + formoterol dry powder inhaler (DPI) 4.5 mg in separate inhalers, budesonide pMDI 160 mg, formoterol DPI 4.5 mg, or placebo. Study II involved 480 patients with mild-to-moderate asthma who were randomized after a two-week run-in (current asthma treatment discontinued) into one of four groups, including: therapy with two inhalations twice daily with SYMBICORT (budesonide/formoterol pMDI) 80/4.5 mg, budesonide pMDI 80 mg, formoterol DPI 4.5 mg, or placebo. Bronchodilatory response was measured by the median time to achieve ≥15% improvement in forced expiratory volume in one second (FEV1) how much air a person can exhale during a forced breath in the first second of exhalation, which is a measure of how well the lungs are functioning after medicine was taken.

Results showed that after the first dose of therapy (day of randomization), the median time to ≥15% FEV1 improvement was significantly earlier (P<.001, Wilcoxon test) with SYMBICORT pMDI versus budesonide pMDI and placebo and similar to formoterol in both studies.

Abstract #972: Changes in asthma control measures were investigated in a 12-week, multicenter, double-blind, placebo-controlled study evaluating 480 patients aged 12 and older with mild-to-moderate persistent asthma receiving inhaled corticosteroids. Patients were randomized to receive therapy with two inhalations twice daily with SYMBICORT (budesonide/formoterol pMDI) 80/4.5 mg, budesonide pMDI 80 mg, formoterol DPI 4.5 mg, or placebo after a two-week run-in. The data demonstrated that SYMBICORT resulted in significantly greater improvements in measures of asthma control (i.e., day/night time peak expiratory flow (PEF) the maximum speed of a forced breath, day/night time symptom scores, percent of symptom-free days, awakening-free nights, rescue medication-free days, and asthma control days) versus placebo, and greater improvements in some measures of asthma control versus its monocomponents (budesonide or formoterol).

Abstracts #7&17: The safety and therapy effects of SYMBICORT (budesonide/formoterol pMDI) on lung function versus its monocomponents (budesonide and formoterol) or placebo were assessed in a 12-week randomized, double-blind, double-dummy, placebo-controlled, multicenter study evaluating 596 patients 12 years and older with moderate-to-severe asthma who were previously treated with inhaled corticosteroids. After a two-week run-in period (two inhalations budesonide pMDI 80 μg bid), symptomatic patients were randomized to receive therapy with two inhalations twice daily with one of five therapys including SYMBICORT (budesonide/formoterol pMDI) 160/4.5 μg, budesonide pMDI 160 μg + formoterol DPI 4.5 μg in separate inhalers, budesonide pMDI 160 μg, formoterol DPI 4.5 μg, or placebo. Results showed SYMBICORT provided improvements in lung function (measured by morning predose FEV1, 12-hour mean postdose FEV1, and morning and evening PEF) significantly greater than its monocomponents (budesonide and formoterol) or placebo and was well tolerated.


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Did you know?
Wilmington, DE February 24, 2007 New data demonstrated the maintenance combination asthma treatment, SYMBICORT (budesonide/formoterol fumarate dehydrate), provides a rapid, clinically significant bronchodilatory response, or opening of the airways, defined as the median time to achieve and#8805;15% improvement in lung function within 15 minutes after administration. In addition, these data demonstrated that compared to its monocomponents (budesonide and formoterol) and placebo, SYMBICORT and the other therapy groups containing formoterol had a faster bronchodilatory response than budesonide or placebo. The combined study results, involving patients with mild-to-severe persistent asthma who previously mandatory therapy with inhaled corticosteroids (ICS), were presented today at the annual meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI) held in San Diego, February 23-27, 2007.

Medicineworld.org: Symbicortand Improves Lung Function

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