AstraZeneca today announced results from the SYMBICORT® (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol LABA (long-acting beta2-adrenergic agonist) safety study showing patients with controlled and uncontrolled asthma had a comparable risk of serious asthma-related events and a lower risk of asthma exacerbations when formoterol was combined with budesonide versus budesonide alone.
The study compared the safety of formoterol, a LABA, used in combination with budesonide, an inhaled corticosteroid (ICS)–the two active therapies in SYMBICORT pressurized metered dose inhaler (pMDI)–against budesonide (pMDI) to evaluate the risk of serious asthma-related events. These events are defined as a composite endpoint of asthma related events including asthma-related deaths, intubations, and hospitalizations, with time to first serious asthma-related event as the primary endpoint.
The results showed a comparable risk of serious asthma-related events when formoterol was combined with budesonide versus budesonide alone. Based on a predefined non-inferiority margin, the upper limit of the 95% confidence interval (CI) for the hazard ratio (HR) of the primary safety endpoint needed to be less than two. As a result, the findings demonstrated statistical non-inferiority of SYMBICORT to budesonide for time to first serious asthma-related event (HR [1.073], 95% CI, [0.698-1.650]). Furthermore, SYMBICORT therapy resulted in a 16.5% lower risk of asthma exacerbations than budesonide (HR, 0.835; 95% CI, 0.745 to 0.937; P = 0.002).
Full study results are now available in The New England Journal of Medicine. The study began in 2011 as a post-marketing requirement by the U.S. Food and Drug Administration (FDA) and all manufacturers of LABA-containing products indicated for the treatment of asthma in the U.S. were required to conduct similar studies evaluating the safety of LABAs when used in combination with an ICS.
Gregory Keenan, Vice President and Head Medical Officer, US Medical Affairs, said: “These findings reconfirm the well-established safety profile of SYMBICORT as demonstrated in our robust clinical program and extensive post-marketing surveillance from around the world. We are pleased to see the importance of ICS/LABA combination therapy in the management of asthma further validated through this study’s findings and its publication in The New England Journal of Medicine.”
The study was conducted at 534 centers in 25 countries and included patients 12 years of age or older with a documented clinical diagnosis of asthma for at least 1 year who were either currently being treated with an inhaled corticosteroid/long-acting β2-agonist (ICS/LABA) combination, or who had asthma that was not adequately controlled on a long-term asthma control medication, or whose disease severity warranted initiation of treatment with ICS/LABA. Patients had at least one asthma exacerbation in the previous year. In total, 11,693 patients were randomized to either SYMBICORT pMDI (two inhalations of 80/4.5 micrograms or 160/4.5 micrograms) or budesonide pMDI (two inhalations of 80 micrograms or 160 micrograms) twice daily for 26 weeks. Forty-three patients receiving SYMBICORT experienced 49 serious asthma-related events and 40 patients receiving budesonide experienced 45 serious asthma-related events. Two asthma-related deaths occurred, both in the SYMBICORT arm; one of these patients also experienced an asthma-related intubation. The remaining events were asthma-related hospitalizations.
AstraZeneca has shared these results with the FDA and will soon be discussing next steps in line with post-marketing requirements.
SYMBICORT is indicated for the treatment of asthma in patients 12 years and older (also see Boxed WARNING).
SYMBICORT 160/4.5 is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
SYMBICORT is NOT indicated for the relief of acute bronchospasm.
IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING
Please see full Prescribing Information, including Boxed WARNING and Medication Guide .
NOTES TO EDITORS
About the Study
The global, multi-center study was a 26-week, randomized, double-blind, active-controlled clinical trial comparing SYMBICORT® (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol with budesonide HFA pressurized metered dose inhaler (pMDI). The study evaluated the risk of serious asthma outcomes, defined as asthma-related hospitalizations, intubation or death, in 11,693 adult and adolescent patients 12 years of age and older with controlled and uncontrolled asthma.
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three therapy areas – Respiratory and Autoimmunity, Cardiovascular and Metabolic Diseases, and Oncology. The company is also active in inflammation, infection and neuroscience through numerous collaborations. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca-us.com
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Last updated on: 31/08/2016
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