Healthcare Industry News: sinusitis
News Release - May 10, 2012
SYMBICORT(R) (budesonide/formoterol fumarate dihydrate) Long-Term Study Shows Similar Safety Profile When Compared to Budesonide Monotherapy in African-American Patients with Asthma52-week Safety Data Published in The Journal of Allergy and Clinical Immunology
WILMINGTON, Del.--(Healthcare Sales & Marketing Network)--AstraZeneca (NYSE:AZN ) today announced the publication of data demonstrating that SYMBICORT Inhalation Aerosol 320/9 µg twice daily had a safety profile similar to budesonide pressurized metered-dose inhaler (pMDI)* 320 µg twice daily in a 52-week study in African-American patients with moderate-to-severe persistent asthma. The most common adverse events, regardless of study drug relationship, were headache, nasopharyngitis, sinusitis, and viral upper respiratory tract infection. No unexpected patterns of abnormalities were observed in laboratory, electrocardiographic, or Holter monitoring assessments. These data have been published in the May 1st online edition of The Journal of Allergy & Clinical Immunology (JACI).
More than 22 million Americans are living with asthma, including 2.3+ million African Americans.
“These findings provide important information about the use of SYMBICORT in African-American patients with persistent asthma, and may help guide healthcare professionals considering treatment therapies for their appropriate patients with asthma,” said Frank Trudo, Associate Medical Director, AstraZeneca. "This trial is part of AstraZeneca's commitment to studying SYMBICORT in patient populations with disproportionate asthma prevalence."
There have been few prior long-term studies evaluating combination inhaled corticosteroid (ICS)/long-acting ß2-adrenergic agonist (LABA) combination medications in specific ethnic populations with moderate to severe persistent asthma not adequately controlled on ICSs alone. Results from this 52-week study are commensurate with safety data from the TITAN study, a 12-week study of SYMBICORT in African-American patients, and with previous SYMBICORT studies that included Hispanic and Caucasian patients.
Cardiovascular safety sub-analysis results from the present study will be presented at the International American Thoracic Society Conference, being held May 18th-23rd in San Francisco, CA (Abstract #31858).
About the Study
The 52-week, randomized, double-blind Phase IIIb safety study included 742 self-reported African-American patients 12 years of age and older with moderate-to-severe persistent asthma previously receiving medium to high-dose inhaled corticosteroids. After two weeks of receiving twice-daily budesonide 320 µg pMDI, patients were randomized to receive twice-daily SYMBICORT 320/9 µg or twice-daily budesonide pMDI 320 µg.
Adverse events (AEs) were recorded in electronic diaries and assessed by investigators for a causal relationship to the study medication. Designed as a safety study, no single efficacy variable was considered primary. Spirometric variables, including predose FEV1 and forced vital capacity (FVC), were performed according to American Thoracic Society guidelines (at screening; randomization; days 14 and 45; months 3, 6, 9, and 12) at least 6 hours after albuterol use and approximately 12 hours after study medication use. Daily diary-based measures of asthma control included morning peak expiratory flow (PEF) (L/min), rescue medication use (via inhaler or nebulizer), rescue medication–free days, symptom-free days, and asthma control days (no asthma symptoms or rescue medication use).
*Budesonide pressurized metered-dose inhaler (pMDI) is a product that is allowed for use as a clinical study comparator but is not approved for commercialization.
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
For more information about AstraZeneca in the U.S. or our AZ&Me™ Prescription Savings programs, please visit: www.astrazeneca-us.com or call 1-800-AZandMe (292-6363).
SYMBICORT is a registered trademark, and AZ&Me is a trademark, of the AstraZeneca group of companies. ©2012 AstraZeneca. All rights reserved.
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