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Medicineworld.org: SYMBICORT in children with persistent asthma

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SYMBICORT in children with persistent asthma




A new 12-week study2examined safety and efficacy measures of the maintenance combination asthma treatment, 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 medicine use and rescue medication-free days in patients taking SYMBICORT in comparison 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.



SYMBICORT in children with persistent asthma

Children with asthma, who are not adequately controlled by ICS treatment, may have their sleep affected by asthma symptoms,6 said Kathy Lampl, MD, Director, Clinical Research, AstraZeneca. Combination treatment 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 treatment alone, as per 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 reviewed 411 children ages 6 to 15 years old with mild to moderate persistent asthma1,2 previously treated with ICS treatment.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 therapy 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 medicine 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 therapy 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 medicine use (p<0.05) and rescue medication-free days (p<0.05) were reported for patients taking SYMBICORT in comparison to those taking formoterol.1 Improvements in nighttime asthma symptom scores and nighttime rescue medicine 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 therapy, 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 therapy 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.


Posted by: JoAnn    Source




Did you know?
A new 12-week study2examined safety and efficacy measures of the maintenance combination asthma treatment, 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 medicine use and rescue medication-free days in patients taking SYMBICORT in comparison 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.

Medicineworld.org: SYMBICORT in children with persistent asthma

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