Wilmington, DE – May 20, 2008 – A new 12-week study2examined safety and efficacy measures of the maintenance combination asthma therapy, SYMBICORT® (budesonide/formoterol fumarate dehydrate) Inhalation Aerosol,2 in treating mild to moderate persistent asthma in children ages 6 to 15 years old2 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 asthma1,2 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 patients1,2 were randomized to receive treatment with SYMBICORT pMDI 40/4.5 mcg two inhalations twice-daily, 1451,2 were randomized to receive budesonide pMDI 40 mcg two inhalations twice-daily, and 1381,2 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 > 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 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. 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. Available at 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. Available at http://www.aafa.org/display.cfm?id=8&sub=16&cont=586.
5. Symbicort Prescribing Information.
6. Vargas PA, et al. Symptom Profile and Asthma Control in School-Aged Children. 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. Retrieved on 25 April 2008. Available at http://www.nhlbi.nih.gov/guidelines/asthma.