Study Analyzed Long-Term Symbicort Use in Children With Persistent AsthmaSYMBICORT Was Well Tolerated in 26-Week Study
WILMINGTON, Del., March 17, 2008 /PRNewswire-FirstCall/ -- A new study analyzed long-term use of the maintenance combination asthma therapy, SYMBICORT(R) (budesonide/formoterol fumarate dihydrate), in treating persistent asthma in children 6 to 11 years old. The study examined the safety of SYMBICORT in children for 26 weeks and also included efficacy measures. For children previously treated with inhaled corticosteroid, either alone or in combination, the study showed that long-term treatment with SYMBICORT resulted in significantly greater improvements in lung function and reduced healthcare resource utilization, compared with budesonide dry powder inhaler (DPI) alone. In the study, SYMBICORT also had a safety profile similar to its monocomponent, budesonide, which is an approved asthma medication for children. Results were presented today at the American Academy of Allergy, Asthma & Immunology Annual Meeting held in Philadelphia, March 14-18, 2008.
"According to the NIH Guidelines, combination therapy is recommended for children whose asthma is not adequately controlled with inhaled corticosteroids alone," said lead investigator Jeffrey Leflein, MD, Allergy & Immunology Associates of Ann Arbor, Michigan.
The study defined resource utilization directly and indirectly. Direct utilization was defined as urgent care center visits due to asthma, unscheduled healthcare provider visits, unscheduled phones calls to physicians and hospitalizations due to serious adverse events. Indirect utilization was defined as days children were unable to participate in activities, days caregivers missed work due to their child's asthma and caregivers' days interrupted.
AstraZeneca 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 Studies (Abstracts #28 and #597)
Long-term safety was assessed during a 26-week multicenter, randomized, open-label study that evaluated 186 children ages 6 to 11 years old with persistent asthma that were previously treated with inhaled corticosteroid, either alone or in combination. After one week on their usual ICS therapy, 123 patients were randomized to receive treatment with two inhalations twice-daily SYMBICORT (budesonide/formoterol pressurized metered-dose inhaler (pMDI)) 160/4.5 micrograms, and 63 were randomized to receive two inhalations twice- daily budesonide dry powder inhaler (DPI) 160 micrograms.
Predose 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 airflow and is reduced with airflow obstruction -- was measured at randomization (baseline) and weeks 2, 12 and 26. Caregivers reported resource utilization weekly. Safety assessments included adverse events, 24-hour urinary cortisol (nmol/24 h) and physical examination, including change from baseline to the end of treatment in height (cm).
Results showed that mean changes in predose FEV1 were significantly greater for SYMBICORT versus budesonide. In addition, the percentage of patients receiving SYMBICORT (3.3%) who had at least one urgent care visit was significantly lower compared with patients using budesonide (11.1%) (p<0.05), and the percentage of patients using SYMBICORT (29.3%) who experienced fewer days unable to participate in daily activities was significantly lower compared with patients using budesonide (44.4%). In both groups, unscheduled visits and phone calls to healthcare providers, use of concomitant asthma medications and interrupted caregiver days were similar. Hospitalizations were low in both groups.
Results also found that SYMBICORT was well tolerated over 26 weeks with a similar safety profile to budesonide. The percentage of patients reporting any adverse events was similar for SYMBICORT (84.6%) and budesonide (85.7%). Most adverse events reported were mild or moderate in intensity and did not lead to discontinuation. The incidence of drug-related adverse events was low and similar with both SYMBICORT (4.9%) and budesonide (6.3%). The most common adverse events reported were headache, upper respiratory tract infection and nasopharyngitis, also known as the common cold.
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 two proven asthma medications -- 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.
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 http://www.MySYMBICORT.com
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.
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Posted: March 2008