WILMINGTON, Del., May 20 /PRNewswire-FirstCall/ -- A new 12-week
study(2) examined safety and efficacy measures of the maintenance
combination asthma therapy, SYMBICORT(R) (budesonide/formoterol fumarate
dehydrate) Inhalation Aerosol(2) in treating mild to moderate persistent
asthma in children ages 6 to 15 years old(2) who were previously treated
with an inhaled corticosteroid (ICS).(2) Of note, the study included
efficacy assessments of nighttime symptoms, nighttime rescue medication use
and rescue medication-free days in patients taking SYMBICORT compared to
those taking formoterol dry powder inhaler (DPI) or budesonide pressurized
metered-dose inhaler (pMDI). Results were presented today at the
International Conference of the American Thoracic Society held in Toronto,
Canada, May 16-21, 2008.
"Children with asthma, who are not adequately controlled by ICS
therapy, may have their sleep affected by asthma symptoms,"(6) said Kathy
Lampl, MD, Director, Clinical Research, AstraZeneca. "Combination therapy
with inhaled ICS and LABA is one of the recommended regimens for children
who have moderate to severe persistent asthma or are not controlled with
ICS therapy alone, according to the NIH Guidelines."(7)
AstraZeneca (NYSE: AZN) anticipates filing a supplemental new drug
application with the Food and Drug Administration for the pediatric
indication of SYMBICORT in the first half of 2008.
About the Study (Abstracts #K66 and K67)
The safety profile and efficacy measures of SYMBICORT were assessed
during a 12-week randomized, double-blind, active-controlled study that
evaluated 411 children ages 6 to 15 years old with mild to moderate
persistent asthma(1,2) previously treated with ICS therapy.(1,2) After a
two-week period during which patients discontinued their current asthma
medications and received two inhalations twice-daily of budesonide pMDI 40
micrograms (mcg), 128 patients(1,2) were randomized to receive treatment
with SYMBICORT pMDI 40/4.5 mcg two inhalations twice-daily, 145(1,2) were
randomized to receive budesonide pMDI 40 mcg two inhalations twice-daily,
and 138(1,2) were randomized to receive formoterol DPI 4.5 mcg two
inhalations twice-daily.(1,2)
The study assessed changes in predose AM and PM peak expiratory flow
(PEF),(1) which measures the maximum flow of air a person can blow out
during a forced breath (the maximum flow achieved during forced
expiration),(3) and predose forced expiratory volume in one second
(FEV1),(1) which quantifies how much air a person can exhale during a
forced breath in the first second of exhalation.(4) In addition, patients
and caregivers were instructed to use an electronic diary twice a day to
record asthma symptom scores on a scale of 0 to 3 (0=none; 3=severe),
nighttime symptoms due to asthma and nighttime rescue medication use.(1)
Safety assessments included reported adverse events, electrocardiograms
(ECG), clinical chemistry and vital signs.(2)
Results revealed significantly greater improvements from baseline to
the average over the treatment period in predose AM and PM PEF for
SYMBICORT (23.6 +/- 32.6 and 19.6 +/- 28.4) compared with its
mono-components, budesonide (8.0 +/- 26.7 and 6.4 +/- 25.0 L/min) and
formoterol (8.6 +/- 30.3 and 6.9 +/- 29.0 L/min).(1) SYMBICORT also
demonstrated significantly greater improvements (p<0.05) in predose and
postdose FEV1 compared with budesonide.(1) Significant improvements in
asthma control as assessed by nighttime symptoms (p<0.05), nighttime rescue
medication use (p<0.05) and rescue medication-free days (p<0.05) were
reported for patients taking SYMBICORT compared to those taking
formoterol.(1) Improvements in nighttime asthma symptom scores and
nighttime rescue medication use were similar between patients taking
SYMBICORT and those taking budesonide.(1)
Results also showed that SYMBICORT was well tolerated for 12 weeks with
a safety profile similar to its mono-components, budesonide and
formoterol.(2) The percentage of patients reporting any adverse events,
regardless of treatment, was similar for SYMBICORT (70.3%), budesonide
(63.4%) and formoterol (70.3%).(2) Most adverse events reported were of
mild or moderate intensity and did not lead to discontinuation.(2)
Drug-related adverse events for all treatment groups were SYMBICORT (3.1%);
budesonide (3.4%); and formoterol (6.5%).(2) No drug-related events led to
the discontinuation of SYMBICORT.(2) The most common drug-related adverse
events reported were asthma related adverse events, headache, insomnia and
cough.(2)
About SYMBICORT
SYMBICORT is a combination therapy indicated for the long-term
maintenance treatment of asthma in patients 12 years of age and older.(5)
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).(5) SYMBICORT does not replace
fast-acting inhalers and should not be used to treat acute symptoms of
asthma.(5)
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.
For full Prescribing Information, please visit
http://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 http://www.astrazeneca-us.com.
References
1. Murphy, K.R., Pearlman, D.S., Uryniak, T., O'Brien, C.D., Mezzanotte,
W.S. Efficacy of Budesonide/Formoterol Pressurized Metered-Dose Inhaler
(BUD/FM pMDI) in Children With Asthma Previously Treated With Inhaled
Corticosteroids (ICSs) [poster]. American Thoracic Society, May 16-21,
2008, Toronto. Abstract #K66.
2. Pearlman, D.S., Murphy, K.R., Uryniak, T., O'Brien, C.D., Mezzanotte,
W.S. Safety of Budesonide/Formoterol Pressurized Metered-Dose Inhaler
(BUD/FM pMDI) in Children With Asthma Previously Treated With Inhaled
Corticosteroids (ICSs) [poster]. American Thoracic Society, May 16-221,
2008, Toronto. Abstract #K67.
3. Peak Flow Meters. Asthma and Allergy Foundation of America. Retrieved
on 25 April 2008. http://www.aafa.org/display.cfm?id=8&sub=16&cont=62
4. Know Your Asthma Numbers! Asthma and Allergy Foundation of America.
Retrieved on 25 April 2008.
http://www.aafa.org/display.cfm?id=8&sub=16&cont=586
5. Symbicort Prescribing Information.
6. Vargas PA, et al. Annals of Allergy Asthma and Immunology
2006;96(6):787-93.
7. National Asthma Education and Prevention Program. NIH/NHLBI.
Publication Number 08-4051, 2007. Available at
http://www.nhlbi.nih.gov/guidelines/asthma.
SOURCE AstraZeneca
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Related links:
http://www.astrazeneca-us.com
http://www.MySYMBICORT.com
http://www.prnewswire.com/comp/985887.html/
CONTACT:
Michele Meeker, +1-302-885-6351,
michele.meeker@astrazeneca.com, or Katie Neff, +1-302-885-9960,
katie.neff@astrazeneca.com, both of AstraZeneca
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