New Patient Satisfaction Study With budesonide/formoterol Combination Therapy and...

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).
About SYMBICORT
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.
Please see full Prescribing Information and visit www.MySYMBICORT.com.
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. For
more information visit www.astrazeneca-us.com.

References
(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

Michele Meeker, +1-302-885-6351, michele.meeker@astrazeneca.com, Katie Neff,
+1-302-885-9960, katie.neff@astrazeneca.com, both of AstraZeneca