Navigation Links
Study analyzed SYMBICORT in children with persistent asthma
Date:5/20/2008

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


'/>"/>

Contact: Katie Neff
katie.neff@astrazeneca.com
302-885-9960
Edelman Public Relations
Source:Eurekalert

Related medicine news :

1. Penn study finds pro-death proteins required to regulate healthy immune function
2. New study shows promise in reducing surgical risks associated with surgical bleeding
3. Study, meta-analysis examine factors associated with death from heatstroke
4. Study suggests loss of 2 types of neurons -- not just 1 -- triggers Parkinsons symptoms
5. Study says COPD testing is not measuring up
6. Preclinical study suggests organ-transplant drug may aid in lupus fight
7. Ability to cope with stress can increase good cholesterol in older white men, study finds
8. High alcohol consumption increases stroke risk, Tulane study says
9. Mailman School of Public Health study examines link between racial discrimination and substance use
10. Pitt study finds inequality in tobacco advertising
11. Stanford study highlights cost-effective method of lowering heart disease risks
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/13/2016)... ... February 13, 2016 , ... ... becomes the first in the area to offer AngioPlex™ Optical Coherence Tomography (OCT) ... disease, such as macular degeneration, diabetic retinopathy, and other vascular conditions. , In ...
(Date:2/13/2016)... ... February 13, 2016 , ... The National Association for Children ... organization representing the growing community of recovering individuals (now over 23 million), to ... in policies addressing addiction. , Although many of the presidential candidates of ...
(Date:2/13/2016)... ... February 13, 2016 , ... The producers of Enterprises TV ... , The increasingly modern world of instantaneous consumption proves very convenient for businesses. ... such as oil and coal, which pollutes our air, water, and soil. It can ...
(Date:2/13/2016)... ... February 13, 2016 , ... When an Au Pair comes all the way ... they are in for and they are often worried things won’t go well. More often ... for. This year’s Au Pair of the Year winner’s all commented how their Au Pairs ...
(Date:2/12/2016)... CA (PRWEB) , ... February 12, 2016 , ... According ... hernia surgeries are beginning to account for a significant portion of hernia repairs throughout ... Towfigh of the Beverly Hills Hernia Center notes that this trend has not only ...
Breaking Medicine News(10 mins):
(Date:2/12/2016)... MONTREAL , February 12, 2016 ... sofern nicht anders vermerkt)   ... Unternehmens http://www.telestatherapeutics.com abrufbar.    ... Website des Unternehmens http://www.telestatherapeutics.com ... Inc. (TSX:TST; PNK:BNHLF) veröffentlichte heute seinen Konzernabschluss ...
(Date:2/12/2016)... 2016  SI-BONE, Inc., a medical device company that pioneered the ... invasive surgical (MIS) device indicated for fusion for certain disorders of ... the Medicare Administrative Contractor (MAC) covering the states of ... , Massachusetts , Minnesota ... , Rhode Island , Vermont ...
(Date:2/12/2016)... 2016  Memorial Hermann Health System has teamed up ... to bring a one-of-a-kind experience to pediatric patients at ... such as 360-degree video and Google Cardboard, Howard was ... – giving the patients and their families an unexpected, ... caught on video . Memorial Hermann ...
Breaking Medicine Technology: