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Study Compares Bronchodilatory Effects of SYMBICORT(R) and Advair in Adults With Asthma
Date:3/18/2008

Data Showed Faster Onset with SYMBICORT with Improved Lung Function within

3 and 15 Minutes

WILMINGTON, Del., March 18 /PRNewswire-FirstCall/ -- Data from a new study demonstrated that the combination asthma maintenance therapy, SYMBICORT(R) (budesonide/formoterol fumarate dihydrate), provided greater and faster bronchodilatory effects, or opening of the airways, compared with Advair (fluticasone propionate/salmeterol) in adults with mild to moderate asthma. In addition, these data demonstrated that SYMBICORT provided a similar bronchodilatory response to albuterol. Bronchodilatory response is defined as the mean time to achieve improvement in lung function. The results from the two studies were presented at the American Academy of Allergy, Asthma & Immunology Annual Meeting held in Philadelphia, March 14-18, 2008.

"SYMBICORT is a combination of two proven asthma medications - budesonide and formoterol. It reduces inflammation experienced on a chronic basis to help patients breathe easier and offers fast action, dose after dose, for bronchodilation (or opening of the lungs)," said lead investigator Frank C. Hampel, Jr., MD, Central Texas Health Research, New Braunfels, Texas.

In both studies, bronchodilatory response was measured by the mean improvements 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 airway function and can be reduced with airway obstruction. Assessments were made at multiple time points over 12 hours including those at three minutes and 15 minutes after the medication was taken.

"SYMBICORT works quickly to improve airflow within 15 minutes, helping patients to breathe better throughout the day and night," said Philip Silkoff, MD, Medical Science, AstraZeneca. "It's important for patients, whose doctors have prescribed a daily maintenance medication to control inflammation, to take their medicine because even though they are symptom-free, they're not asthma-free. Asthma never goes away."

Study Results (Abstract #859)

Bronchodilatory response rate was investigated in two identically designed, multicenter, single-dose, four-period crossover studies. The studies were conducted in 109 patients (SD-039-0732, N=55; SD-039-0733, N=54) ages 18 years and older with mild to moderate asthma previously receiving ICS therapy. After a two-week run-in (two inhalations twice-daily budesonide pressurized metered-dose inhaler (pMDI) 80 micrograms), patients were randomized into one of four groups to receive once-daily treatment with two inhalations of SYMBICORT (budesonide/formoterol pMDI) 80/4.5 micrograms, one inhalation of fluticasone propionate/salmeterol dry powder inhaler (DPI) 250/50 micrograms, two inhalations of albuterol pMDI 90 micrograms or placebo. Each treatment was separated by a 3- to 14-day washout period.

In both studies, results showed that mean improvements in FEV1 at three minutes postdose were significantly greater with SYMBICORT and albuterol pMDI compared to fluticasone propionate/salmeterol DPI (P<.001). At the same time, all active treatments resulted in significantly greater FEV1 at three minutes postdose compared to placebo (P less than or equal to .029). In addition, significantly (P<.001) more patients (combined studies) achieved greater than or equal to 15 percent and greater than or equal to 12 percent improvements in FEV1 within 15 minutes postdose with SYMBICORT and albuterol pMDI versus fluticasone propionate/salmeterol DPI. All treatments were well tolerated.

About SYMBICORT

SYMBICORT is a combination therapy indicated for the long-term maintenance treatment of asthma in patients 12 years of age and older. Administered twice daily SYMBICORT is a combination of budesonide, an inhaled corticosteroid (ICS), and formoterol, a rapid and long-acting beta2-agonist (LABA). SYMBICORT does not replace fast-acting inhalers and should not be used to treat acute symptoms of asthma. SYMBICORT has safety data in long-term studies of up to one year, and has a robust cardiac safety profile.

Important Safety Information

Long acting beta2-adrenergic agonists may increase the risk of asthma- related death. Therefore, when treating patients with asthma, SYMBICORT should only be used for patients not adequately controlled on other asthma-controller medications (e.g., low-to-medium dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with two maintenance therapies. Data from a large placebo-controlled U.S. study compared the safety of another long-acting beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol may apply to formoterol (a long-acting beta2-adrenergic agonist), one of the active ingredients in SYMBICORT.

SYMBICORT is not indicated for the relief of acute bronchospasm.

SYMBICORT should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma.

Particular care is needed for patients who are transferred from systemically active corticosteroids. Deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids.

Patients who are receiving SYMBICORT twice daily should not use additional formoterol or other long-acting inhaled beta2-agonists for any reason.

Common adverse events reported in clinical trials, occurring in greater than or equal to 5 percent of patients, regardless of relationship to treatment, including nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, and stomach discomfort.

Please see full Prescribing Information and visit http://www.MySYMBICORT.com

About AstraZeneca

AstraZeneca (NYSE: AZN) is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. In the United States, AstraZeneca is a $13.35 billion dollar healthcare business with 12,200 employees committed to improving people's lives. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

For more information visit http://www.astrazeneca-us.com.


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SOURCE AstraZeneca
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