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New Patient Satisfaction Study With budesonide/formoterol Combination Therapy and fluticasone/salmeterol Combination Therapy in Adults With Asthma

WILMINGTON, Del., May 20 /PRNewswire-FirstCall/ -- A new open-label study evaluated patient satisfaction with budesonide/formoterol combination therapy and fluticasone/salmeterol combination therapy, as measured by the Asthma Treatment Satisfaction Measure (ATSM)(1). Patients participating in the study were ages 18 years and older with moderate to severe asthma(1) and had been previously treated with inhaled corticosteroids(1). Results were presented today at the International Conference of the American Thoracic Society held in Toronto, May 16-21, 2008.

Results showed that patients receiving budesonide/formoterol combination therapy administered as adjustable dosage reported significantly greater satisfaction on the ATSM overall (p=0.02) than patients receiving fluticasone/salmeterol combination therapy, especially in the categories of feel medication begins to work (p<0.001), dosing management (p<0.001), and timely relief of symptoms (p=0.037)(1). Patients receiving budesonide/formoterol combination therapy fixed dose reported significantly greater satisfaction for timely relief of symptoms (p=0.002) and feeling the medication begin to work (p=0.02) compared to patients receiving fluticasone/salmeterol combination therapy(1). Budesonide/formoterol combination therapy is not indicated for adjustable dosing in the U.S.

"These data showed that patients treated with budesonide/formoterol combination therapy fixed dose were more satisfied with the timeliness of their symptom relief than those patients treated with fluticasone/salmeterol combination therapy," said lead investigator Richard O'Connor, MD, of the University of California-San Diego.

About the ATSM

Patient satisfaction was assessed using the recently validated 11-item Asthma Treatment Satisfaction Measure (ATSM)(1). Scores range from 0-100, with the higher scores equaling greater satisfaction(1). Categories included symptom relief, onset of action, sensations that medications are working and self-management of dosing, as well as seven other related categories(1). The assessment of overall satisfaction was based on all the eleven ATSM items.

About the Study Design (Abstract A13)

Patient satisfaction was assessed in an open-label study involving 832 patients ages 18 years and older with moderate to severe asthma who were previously treated with ICS(1). After a 10-14 day run-in on previous ICS therapy, patients were randomized 2:1 to receive twice daily treatment with two inhalations of budesonide/formoterol combination therapy pressurized metered-dose inhaler (pMDI) fixed dose at 160/4.5 micrograms (mcg) (N=698) or twice daily treatment with one inhalation of fluticasone/salmeterol combination therapy dry powder inhaler (DPI) at 250/50 mcg (N=350)(1). After one month, patients on budesonide/formoterol combination therapy pMDI fixed dose were randomized 1:1 to continue budesonide/formoterol combination therapy pMDI fixed dose (N=333) or budesonide/formoterol combination therapy adjustable dose (N=330) at either once daily treatment with two inhalations of 160/4.5 mcg, twice daily treatment with two inhalations of 160/4.5 mcg, or twice daily treatment with four inhalations of 160/4.5 mcg for six months. The patients originally treated with fluticasone/salmeterol combination therapy remained on that medication (N=335)(1).


SYMBICORT is a combination therapy indicated for the long-term maintenance treatment of asthma in patients 12 years of age and older(2). Administered twice daily, SYMBICORT is a combination of two proven asthma medications -- budesonide, an inhaled corticosteroid (ICS), and formoterol, a rapid and long- acting beta2-agonist (LABA)(2). SYMBICORT does not replace fast-acting inhalers and should not be used to treat acute symptoms of asthma(2).

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.

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About AstraZeneca

AstraZeneca 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.
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(1) O'Connor, R.D., Patrick, D.L., Parasuraman, B., Martin, P., Goldman,

M. Patient Satisfaction During Treatment With Adjustable-Dose

Budesonide/Formoterol Pressurized Metered-Dose Inhaler (BUD/FM pMDI),

Fixed-Dose BUD/FM pMDI, and Fixed-Dose Fluticasone/Salmeterol Dry

Powder Inhaler (FP/SM DPI) [poster]. American Thoracic Society, May

16-21, 2008, Toronto. Abstract #A13.

(2) Symbicort Prescribing Information.

SOURCE AstraZeneca
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